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Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life
Accepted Manuscript Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life
Rafael García Molina, Marta Carolina Ruíz Grao, Alicia Noguerón García, Marta Martínez Reig, Mariano Esbrí Víctor, Míkel Izquierdo Redín, Pedro Abizanda Soler PII: DOI: Reference:
S0531-5565(18)30106-2 doi:10.1016/j.exger.2018.05.013 EXG 10365
To appear in:
Experimental Gerontology
Received date: Revised date: Accepted date:
13 February 2018 10 May 2018 15 May 2018
Please cite this article as: Rafael García Molina, Marta Carolina Ruíz Grao, Alicia Noguerón García, Marta Martínez Reig, Mariano Esbrí Víctor, Míkel Izquierdo Redín, Pedro Abizanda Soler , Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Exg(2017), doi:10.1016/ j.exger.2018.05.013
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ACCEPTED MANUSCRIPT Title: Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life. Running Title: Exercise in older adults with falls in real life.
Authors
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Rafael García Molina, Sport scientist, PhD. Geriatrics Department, Complejo
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Hospitalario Universitario de Albacete, Albacete, Spain.
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Marta Carolina Ruíz Grao, RN. Castilla-La Mancha University, Albacete, Spain. Alicia Noguerón García, MD. Geriatrics Department, Complejo Hospitalario
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Universitario de Albacete, Albacete, Spain.
Marta Martínez Reig, MD, PhD. Geriatrics Department, Complejo Hospitalario
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Universitario de Albacete, Albacete, Spain.
Mariano Esbrí Víctor, MD. Geriatrics Department, Complejo Hospitalario Universitario
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de Albacete, Albacete, Spain.
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Míkel Izquierdo Redín, PhD. Department of Health Sciences, Public University of Navarre, Tudela, Navarre, Spain. CIBER de Fragilidad y Envejecimiento Saludable
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(CB16/10/00315), Instituto de Salud Carlos III, Madrid, Spain. Pedro Abizanda Soler, MD, PhD. Head of the Geriatrics Department, Complejo
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Hospitalario Universitario de Albacete, Albacete, Spain. CIBER de Fragilidad y Envejecimiento Saludable, Instituto de Salud Carlos III, Madrid, Spain. Correspondence Pedro Abizanda Soler Hospital Perpetuo Socorro, C/ Seminario 4, 02006 Albacete, Spain Tel.: +34967597651 Fax: +34967597635 Email: [email protected]
ACCEPTED MANUSCRIPT ABSTRACT Background/Objectives: Multicomponent exercise programs are the cornerstone in preventing gait and balance impairments and falls in older adults. However, the effects of these programs in usual clinical practice have been poorly analyzed. Design: 4-month, twice-a-week multicomponent exercise program cohort study in real-
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life.
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Setting: Falls Unit, Complejo Hospitalario Universitario of Albacete, Spain.
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Participants: Sixty-seven participants who had experienced a fall in the previous year were included.
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Measurements: Pre- and post -intervention measurements were collected for leg press, gait speed, the Short Physical Performance Battery (SPPB), the Falls Efficiency Scale
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International, fat mass percentage, body mass index, the Geriatric Depression Scale by Yesavage (GDS), the Mini Mental State Examination, and the number of falls.
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Results: Fifty participants completed the program (adherence rate 75%, attendance
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80%). Their mean age was 77.2 (SD 5.8) years; 39 were women. The participants reduced the mean number of frailty criteria from 2.1 to 1.3. (95%CI 0.4-1.1) and
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increased mean gait speed from 0.65 m/s to 0.82 m/s (95%CI 0.11-0.22), increasing their median SPPB scores from 8.5 to 10.0 points (p<0.001), leg press strength from
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62.5 kg to 80.0 kg (p<0.001), and leg press power at 60% load from 76 W to 119 W (p<0.001). There was also an improvement in GDS scores from 5.3 to 4.4 (95%CI 0.11.7). Body mass index did not change, but fat-free mass increased from 43.7 kg to 44.2 kg (95%CI 0.1.-1.0), and fat mass percentage declined from 36.7% to 36.0% (95% CI 0.1-1.4). Seventeen patients (34%) had a fall during the six-month follow-up, and there was a reduction in the median number of falls from 3.0/year to 0.0/six months.
ACCEPTED MANUSCRIPT Conclusions: A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with previous falls.
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Key words: Multicomponent Exercise Program, Falls, Older adults, Usual care,
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Physical function
ACCEPTED MANUSCRIPT INTRODUCTION Several recent systematic reviews and meta-analyses have demonstrated that physical exercise is the gold standard treatment for functional improvement in older adults (1-5). Different exercise modalities such as strength, balance, cardiovascular and coordination, have demonstrated functional benefits in frail older adults, although
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multicomponent exercise programs that specifically include strength and power,
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endurance and balance training present a better profile (6-12). Moreover,
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multicomponent exercise programs that include strength and power training have added benefits for cardiovascular and respiratory function; cognitive and affective status;
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increased socialization; and reduced frailty, sarcopenia, falls and fear of falling syndrome (13-17). For these reasons, some authors question the ethics of not
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prescribing physical exercise when frailty is determined in older adults (18). Two physical exercise implementation strategies have been described in frail
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older adults (19). The first is based on home programs in which physical exercise
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experts teach older adults how to conduct the program by themselves at home (13,20), the participants perform physical exercise with direct expert supervision at home (21),
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or the participants follow well-structured programs such as VIVIFRAIL with telematic aids by themselves (22,23). In the second strategy, physical exercise programs are
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directly administered by specialists in this discipline who adapt the type, intensity, frequency and length of the programs to specialized individual needs in controlled spaces (17). Although this last strategy could seem less efficient from an economic approach, it is usually the most effective strategy for older populations (24-26). Until now, most of the published studies on physical exercise in older adults have been randomized clinical trials or have been performed under experimental conditions, but data regarding the real-life results of physical exercise programs among
ACCEPTED MANUSCRIPT older adults with different conditions, such as falls, and in different settings, such as Falls Units at hospitals, are lacking. For this reason, we decided to present the results of two first-years programs in the Multicomponent Physical Exercise Unit at our Falls Unit for frail older adults or older adults who have experienced falls.
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METHODS
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Design
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This was a retrospective study under usual clinical practice conditions conducted in real life, to describe the results of a multicomponent physical exercise program in
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patients older than 64 years with previous falls.
Every participant underwent a basal assessment in the Falls Unit including a
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complete falls history, physical examination, posturography (Neurocom Balance Master, NeuroCom® International, Inc., Clackamas, U.S.A.), gait analysis using
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GaitRite (GAIT Rite Portable Walkway System 427P, CIR Systems, Inc, Franklin, NJ,
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U.S.A.), grip strength measurement (Jamar digital dynamometer, NexGen ergonomics, Pointe Claire, Quebec, Canada), one repetition maximum (1RM) seated leg press
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strength (BH Exercycle X050, Exercycle SL, Vitoria-Gasteiz, Spain), leg press power (T-Force Dynamic Measurement System, Ergotech Consulting SL, Murcia, Spain), in
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the same order with a 3-minute rest between tests in order to diminish fatigue (27), and blood analysis to determine the medical conditions responsible for falls and to determine a management strategy. At the second visit, the patients received a complete diagnosis and medical treatment to reduce the risk and consequences of falls. All patients who were able to walk with or without technical aids (canes or a walker) without personal help were invited to participate in a multicomponent physical exercise program under usual clinical care conditions.
ACCEPTED MANUSCRIPT After finishing the program, all the patients attended a third medical visit aimed at analyzing the results of the program. At six months after the beginning of the intervention, the patients were asked about the occurrence of falls. Patients had been previously trained to register any incident fall during the follow-up period. This procedure represents the usual clinical practice at our Falls Unit.
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“The usual clinical practice at the Falls Unit is based on a comprehensive
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multifactorial assessment of older adults with falls. History of falls, risk factors, drugs,
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frailty and sarcopenia are evaluated. Complete clinical examination, balance analysis with static and dynamic posturography, and gait analysis is performed. Interventions
and
osteoporosis
treatment,
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are individualized according to the findings, including polypharmacy control, vitamin D ophthalmology
referral,
home
environmental
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recommendations, nutritional interventions, and physical exercise as needed.”
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Setting and study subjects
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We included 67 consecutive patients older than 64 years from the community at the Falls Unit of the Complejo Hospitalario Universitario of Albacete. The included
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patients had had at least one fall in the last year and were able to walk with or without technical aids (canes or a walker). All the patients agreed to participate in the program.
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At the baseline visit, we excluded patients who were unable to perform any of the exercises in the program or to understand the instructions given by the sport scientist who conducted the sessions.
Multicomponent Physical Exercise Program The intervention consisted of a twice-a-week, 4-month (32 sessions) multicomponent physical exercise program. The main objective of the program was to
ACCEPTED MANUSCRIPT achieve an improvement in physical function that would reduce future falls. The program was conducted by a sport scientist with the help of a trained nurse. In the first session, the patients completed a modified Senior Fitness Test battery for measuring basal functional fitness (28), including upper and lower limb strength, flexibility, agility, and endurance. We also determined the leg press1RM, leg press
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power, gait speed, and grip strength.
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An individualized multicomponent physical exercise program was designed for
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every patient according to the basal functional level, comorbidities, and previous exercise experience. Individualization was based on the modified Senior Fitness Test
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battery results, adjusting load and intensity to allow a maximum of 30 repetitions for each exercise. Complexity of exercises was also adapted to cognitive status, preferences
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and previous experience of participants. The strength and power program was based on previous work resistance training approaches for older adults (Table 1). It begins with
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low-intensity, high-repetition sessions, ending with high-intensity, low-repetition
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sessions. The patients were asked to perform a combined maximal/explosive resistance training program to improve both strength and power (29,30). In addition to strength
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and power exercises with machines, we included general strength exercises with bands, dumbbells and elastic bands and balance exercises. Moreover, agility, coordination and
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dual-task exercises were included. The sessions ended with flexibility and stretching exercises to cool down. This exercise program was based on the VIVIFRAIL multicomponent physical exercise program to prevent weakness and the risk of falling (22,23). The length of the sessions was 45 minutes approximately, divided in three different parts: a warm-up (10 to 15 minutes); the main exercise program (20 to 25 minutes) consisting on four to six different exercises with 2 to 4 series per each one, a
ACCEPTED MANUSCRIPT recover between series of 30-60 seconds, and a recover between exercises of 60 to 90 seconds; finally return to calm (5 to 10 minutes) with stretching of the main muscle groups and quiet breaths to reduce heart frequency.
Result variables
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Pre and post measures of the following variables were collected: Frailty
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phenotype (31); disability in basic activities of daily living (BADL), assessed with the
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Barthel index (32), and in instrumental activities of daily living (IADL), assessed with the Lawton index (33); fear of falling, assessed with the Falls Efficiency Scale -
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International (FES-I) (34); affective status, assessed with the Geriatric Depression Scale (GDS) by Yesavage (35); and cognitive status, assessed with Folstein´s Mini Mental
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State Evaluation (MMSE) (36). Body composition was determined using body mass index (BMI), fat-free mass (FFM) and the percentage of fat mass, determined with
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bioimpedanciometry (BC-418 Segmental Body Composition Tanita Instrument, Tanita,
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Tokyo, Japan). Physical function was measured with the Short Physical Performance Battery (SPPB) (37), and the three subtests of this battery (gait speed, balance and 5-sit-
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to-stand test) were also independently analyzed. The hand grip strength, 1RM seated leg press strength, and leg press power at 60% (Q60) and 100% (Q100) of 1RM, that means
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60% and 100% of 1RM, were also determined. The 60% 1RM leg press power is within the range observed in the literature that elucidates the maximal power output in older adults on the leg press exercise (27). Three sets of one to three repetitions per load, performed over several representative loads (<50%, 50%–80%, and >80% 1RM, or by a body mass-based incremental protocol), might be optimal to assess muscle power in older adults (27,38). Finally, the participants were asked about the number of falls in the
ACCEPTED MANUSCRIPT previous year, during the exercise program and 6 months from the beginning of the program.
Ethical aspects Our research was conducted in accordance with the Helsinki statement regarding
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human research. The retrospective analysis study was approved by the Ethics Review
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Committee of the Complejo Hospitalario Universitario of Albacete. It was not necessary
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for the participants to give written consent because the program was performed under usual clinical practice conditions in real life. However, all the participants agreed to
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participate in the program and were informed about the conditions and risks, although
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the protocol was part of the usual care for intervention on frailty and falls prevention.
Statistics
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A descriptive analysis was performed. The normal distribution of variables was
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determined by Kolmogorov-Smirnoff test. Results for normally distributed variables are presented by means (standard deviation), and for variables not meeting normal
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distribution the median with the interquartile range is presented. The comparison of the pre- and post-intervention variables following normal distribution were compared using
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paired t-tests with 95% confidence interval (CI) for the means, and in variables not meeting normal distribution criteria Z Wilcoxon rank test for median differences was used. As a result, data from SPPB, Balance subtest SPPB, 5 sit-to-stand test, 1RM leg press, Q100 leg press, Q60 leg press and number of falls are expressed in medians (interquartile range), and significance is analyzed with Z Wilcoxon rank test. All the other variables are expressed in means (standard deviation) and analyzed with paired ttest. Differences in the number of patients with falls and falls/person during the follow-
ACCEPTED MANUSCRIPT up period were described, but no statistical analysis was undertaken because of the absence of a control group. The data were analyzed with SPSS 22.0.
RESULTS We included 67 participants, 50 completed the physical exercise intervention,
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and 17 dropped out at various points in the program, for an adherence rate of 75%, and
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a mean attendance of 80% to the sessions. All participants received intervention with
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vitamin D correction and polypharmacy control, and 20% nutritional intervention. Table 2 presents the baseline characteristics of the complete sample, those who finished the
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intervention program, and those who dropped out. The mean age of the participants who completed the program was 77.2 years (SD 5.8; range 66-88). Most important
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comorbidities were from the circulatory system (91.0%), locomotor system (70.1%), vision (46.3%), nervous system (34.3%) and respiratory system (26.9%), and the most
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prevalent diseases were osteoarthritis 29.9%, diabetes 26.9%, hypertension 23.9%,
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osteoporosis 23.9%, and depression 16.4%. There were no baseline differences between the participants who finished the
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exercise program and those who dropped out in terms of age, female sex, SPPB, number of frailty criteria, hand grip strength and 1RM leg press strength, although the
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participants who finished the program had fewer falls in the previous year than those who dropped out (3.3 and 5.1 mean falls per participant in the previous year respectively). However, one participant who dropped out had 50 falls in the previous year, biasing the mean number of falls in this group. After excluding this patient, the number of falls was 2.3 (SD 1.4), without statistical difference compared to those who finished the program. Because there were no significant differences between
ACCEPTED MANUSCRIPT participants who finished or drop out the program, we decided not to weight the results (39). Table 3 presents the pre- and post-intervention results. The number of frailty criteria decreased from 2.1 per participant to 1.3 (a reduction of 0.8 criteria per participant; 95% CI 0.4-1.1). The Yesavage GDS scores improved from 5.3 to 4.4
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differences in cognitive status before and after the program.
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points per participant (reduction in 0.9 points; 95% CI 0.1-1.7). We found no
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Although the BMI did not change significantly across the program, there was a 0.5 kg increase in FFM per participant (95% CI 0.1-1.0) from 43.7 kg to 44.2 kg with a
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decrease in fat mass from 25.9 kg to 25.4 kg, and consequently a decrease in fat mass percentage from 36.7% to 36.0% (reduction of 0.7%; 95% CI 0.1-1.4).
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Regarding the physical function variables, the participants who finished the program showed improved SPPB median scores, from 8.5 to 10.0, and there was an
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improvement in the mean gait speed subtest of the SPPB from 0.65 m/s to 0.82 m/s
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(increase in 0.17 m/s; 95% CI 0.11-0.22), and median 5 sit-stands subtest of the SPPB from 13.3 sec. to 11.7 sec. There was also an increase in median 1RM leg press strength
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from 62.5 kg to 80.0 kg, and an increasing trend in hand grip strength from 18.0 kg to 18.5 kg (increase of 0.5 kg; 95% CI -0.7-1.9). Regarding leg-press power, there was an
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increase in median Q100 (100% load) of 30.5 W, from 63.0 to 93.5, and in Q60 (60% load) of 43 W from 76.0 to 119.0. Figure 1 presents the main results of physical function tests. Among the 50 participants who finished the program, only 17 (34%) reported a new fall in the 6 months since the study began, and only one participant developed a new fracture. The median number of falls per participant decreased from 3.0 to 0.0 during this follow-up period.
ACCEPTED MANUSCRIPT DISCUSSION Our results show that a Falls Unit-based multicomponent exercise program as part of usual clinical practice in real life in older adults with a previous fall improves physical function, body composition, and affective status and shows a possible reduction in the number of falls. Our work adds to previous knowledge that in selected
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frail populations with previous falls, a Falls Unit-based exercise program directed
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toward improving muscle strength and power is an efficient clinical intervention that
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could be implemented in real life.
Previous meta-analyses have demonstrated that multicomponent group exercise
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significantly reduced the rate of falls (rate ratio [RaR] 0.71, 95% CI 0.63 to 0.82; 16 trials; 3,622 participants) and the risk of falling (risk ratio [RR] 0.85, 95% CI 0.76 to
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0.96; 22 trials; 5,333 participants), as did multicomponent home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; 7 trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94;
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6 trials; 714 participants) (40). In our exercise group, we observed an absolute falls risk
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reduction of 0.34, greater than in previous studies, probably secondary to the characteristics of our participants, a high risk of falls frail population.
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Previous work of Casas Herrero et al. stated that multicomponent exercise programs are the most complete method for improving physical function in frail older
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adult populations (41). These types of programs, which include strength, power and balance exercises, are directed towards physical conditioning, unlike those that only include one modality, such as balance or strength, and only accomplish benefits in that domain. Furthermore, programs that include power training seem to produce greater benefits than those that only include strength exercises because they also improve cardiovascular and respiratory function (42,43). For this reason we decided to include this kind of program as usual clinical practice at our Falls Unit. Our clinical group not
ACCEPTED MANUSCRIPT only improved strength and physical function with this program, but also presented an important increase in leg press power, a more functionally relevant measure of muscle performance than strength (44). Physical exercise in older adults can be implemented in hospital settings, institutions or in the community, but there is little information comparing the efficiency
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of both three settings in frail and faller older adults. In a systematic review (45), only 1
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out of 9 included randomized clinical trials was conducted in a teaching hospital (46),
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not allowing for comparisons. Another study showed more positive health outcomes in supervised/class-based groups in hip fracture older adults than in non-supervised/home-
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based groups (47). The rationale for conducting our program in a hospital setting was to break the negative feed-back of fear of falling and deconditioning in this population
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through a supervised and healthcare protective environment, with a close access to geriatricians and nurses.
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Our program also improved body composition with an increase in fat-free mass
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and a decrease in fat mass. Resistance and power exercise can increase the type I and type II muscle fiber cross-sectional area and lean muscle mass through enhanced muscle
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protein synthesis, anabolic hormone production, satellite cell activation, and reduction of catabolic cytokines (48). It has also been described that more than for physical
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movement, for posture and vital actions, such as chewing, swallowing, and breathing, skeletal muscle also serves as a regulator of interorgan crosstalk for energy and protein metabolism throughout the body, leading not only to functional benefits but also to metabolic benefits (49). It could be argued that the main limitation of our work is the absence of a control group or that the design is not a randomized clinical trial. Although this is true, our findings are in agreement with previous evidence that physical exercise is the gold
ACCEPTED MANUSCRIPT standard treatment for frail older adults and adults with previous falls and that it is not ethical not to prescribe exercise programs for these populations (18). For this reason, the inclusion of control (placebo) groups could be not ethic. Against this background, observational, real-life studies performed under usual clinical practice conditions are mandatory to ascertain that the results of clinical trials can be replicated in real life. The
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European Working Group on Relative Effectiveness has defined real life studies as a
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way to analyze medical data collected under real life conditions, in everyday settings, providing insights into the real life effectiveness of a medical condition/intervention.
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Randomized controlled trials are the “gold standard” for evaluating treatment outcomes
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providing information on treatments “efficacy”, designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason
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they have high internal validity, although the strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in
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conditions very different from real life usual care. However, real life studies describe
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the “effectiveness” of a treatment, allowing for a high generalizability, but low internal validity. The comparison of effectiveness and efficacy studies can provide important
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information about interventions. Both approaches can result complementary, and may guide the interpretation of each other results leading to better clinical decisions (50).
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Another limitation could be the small sample size. However, in the case of frail older adults, the number of participants per group must be small (four to six participants per session maximum) to avoid falls and injuries and increase adherence. For this reason, it is difficult to obtain a large number of participants in a short time. However, the results for our patients were so impressive and similar to those of previous clinical trials, that the sample size was large enough to demonstrate that these programs can be
ACCEPTED MANUSCRIPT effectively implemented in settings with similar characteristics to ours, a teaching hospital with a complete Geriatrics Department. The last limitation of the study could be that physical tests assessment could produce fatigue, biasing the results of the last ones. For this reason tests were performed always in the same order (from low to high metabolic demand), and adequate recovery
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intervals were allowed between them (27). We can´t absolutely confirm that benefits of
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the intervention were solely related to physical exercise because a comprehensive
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geriatric evaluation with clinical interventions was also implemented in the Falls Unit. However, all participants were included in the physical exercise program after a one-to-
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four month period after the clinical visit, thus allowing for a stabilization of medical problems before doing the pre-intervention assessment.
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Although pharmaceutical are the gold standard treatment for almost all medical conditions, an unique finding of the present study was that a Falls Unit-based physical
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exercise program induce positive functional and clinical benefits for frail older patients
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with falling risk. After our experience, we agree with previous authors that the implementation of these strategies in teaching hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations (51). Short Falls Units or Outpatient clinics-based programs may increase self-confidence and
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adherence to exercise in non-exercising frail older adults before they join communitybased or home-based programs (22,23). However, further analysis of other subgroups of older adults and different exercise modalities or intensities could be necessary to find the best approach for every individual using a precision medicine approach (52,53).
ACCEPTED MANUSCRIPT CONCLUSIONS A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with previous falls.
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Implementation of these strategies in hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations. Falls
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Units or Outpatient clinics-based short programs may increase self-confidence and adherence to exercise in non-exercising frail older adults before they join community-
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based or home-based programs.
ACCEPTED MANUSCRIPT DISCLOSURES / CONFLICT OF INTEREST All authors declare that there are no conflicts of interest.
STATEMENT OF AUTHORSHIP P. Abizanda, M. Esbrí and M. Martínez-Reig participated in the study concept
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development as well as the study design, protocol writing and reviewing process. All
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authors participated in the study take-off. R. García-Molina and M.C. Ruíz-Grao
Noguerón analyzed the study results.
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participated in data collection and management. P. Abizanda, M. Esbrí and A. M. Izquierdo reviewed the manuscript, and
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helped with data interpretation and counseling. All authors reviewed and approved the
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final manuscript.
ACKNOWLEDGMENTS
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This work was supported by CIBERFES, Instituto de Salud Carlos III, Ministerio de
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Economía y Competitividad, España. Ayuda cofinanciada por el Fondo Europeo de
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Desarrollo Regional FEDER Una Manera de hacer Europa.
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19. Bauman A, Merom D, Bull FC, Buchner DM, Fiatarone Singh MA. Updating the Evidence for Physical Activity: Summative Reviews of the Epidemiological Evidence, Prevalence, and Interventions to Promote “Active Aging”. Gerontologist 2016; 56 (S2): S268–S280. 20. Latham NK, Harris BA, Bean JF, et al. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA 2014; 311: 700–8.
ACCEPTED MANUSCRIPT 21. Burton E, Lewin CG, Boldy D. A systematic review of physical activity programs for older people receiving home care services. J Aging Phys Act 2015; 23: 460-70. 22. Mikel Izquierdo, Alvaro Casas-Herrero, Fabricio Zambom-Ferraresi, Nicolás Martínez-Velilla,
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Alonso-Bouzón,
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representing VIVIFRAIL. Multi-component physical exercise program to
at:
http://vivifrail.com/resources/send/3-documents/23-e-book-
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Available
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prevent weakness and the risk of falling. ISBN. 978-84-617-9780-6, 2017.
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23. Promoción del ejercicio físico en ancianos frágiles. Programa vivifrail. Available at: http://www.vivifrail.com/es/
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24. Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in
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community-dwelling older adults: Results of a randomized, controlled trial. J
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Am Geriatr Soc 2002; 50: 1921-8. 25. de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millán-Calenti JC.
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Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr 2015; 15: 154.
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26. Martin JT, Wolf A, Moore JL, Rolenz E, DiNinno A, Reneker JC. The effectiveness of physical therapist-administered group-based exercise on fall prevention: a systematic review of randomized controlled trials. J Geriatr Phys Ther 2013; 36: 182-93. 27. Alcazar J, Guadalupe-Grau A, García-García FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing
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F, Gorostiaga EM.Twice-weekly progressive resistance training decreases
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30. Izquierdo M, Häkkinen K, Ibañez J, Garrues M, Antón A, Zúñiga A, Larrión JL,
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Gorostiaga EM. Effects of strength training on muscle power and serum hormones in middle-aged and older men. J Appl Physiol (1985) 2001; 90: 1497-
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Frailty in Older Adults: Evidence for a Phenotype. J Gerontol A Biol Sci Med
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instrumental activities of daily living. Gerontologist 1969; 9: 179-86. 34. Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing 2005; 34: 614-9. 35. Yesavage JA, BrinK TL, Rose TL, Lum O. Development and validation of a geriatric depression scale: a preliminary report. J Psychiat Res 1983; 17: 37-49.
ACCEPTED MANUSCRIPT 36. Folstein MF, Folstein S, McHuth PR. Mini-mental state: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189-98. 37. Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing lower extremity function: association with self-reported
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38. Potiaumpai M, Gandia K, Rautray A, Prendergast T, Signorile JF. Optimal Loads for Power Differ by Exercise in Older Adults. J Strength Cond Res 2016;
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39. Schmidt SCE, Woll A. Longitudinal drop-out and weighting against its bias.
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40. Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson
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LM, et al. Interventions for preventing falls in older people living in the
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community. Cochrane Database Syst Rev 2012 Sep 12; (9): CD007146. 41. Casas Herrero A, Cadore EL, Martínez Velilla N, Izquierdo Redin M. El
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ejercicio físico en el anciano frágil: una actualización. Rev Esp Geriatr Gerontol 2015; 50: 74-81.
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42. Cadore EL, Izquierdo M. How to simultaneously optimize muscle strength, power, functional capacity, and cardiovascular gains in the elderly: an update. Age (Dordr) 2013; 35: 2329-44. 43. Izquierdo M, Cadore EL. Muscle power training in the institutionalized frail: a new approach to counteracting functional declines and very late-life disability. Curr Med Res Opin 2014; 30: 1385-90.
ACCEPTED MANUSCRIPT 44. Tevald MA, Murray AM, Luc B, Lai K, Sohn D, Pietrosimone B. The contribution of leg press and knee extension strength and power to physical function in people with knee osteoarthritis: A cross-sectional study. Knee 2016; 23: 942-9. 45. de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millán-Calenti JC.
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Effects of physical exercise interventions in frail older adults: a systematic
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review of randomized controlled trials. BMC Geriatr 2015; 15: 154.
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46. Latham NK, Anderson CS, Lee A, Bennett DA, Moseley A, Cameron ID, et al. A randomized, controlled trial of quadriceps resistance exercise and vitamin D
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in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). J Am Geriatr Soc 2003; 51: 291-9.
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47. Carmeli E, Sheklow SL, Coleman R. A comparative study of organized classbased exercise programs versus individual home-based exercise programs for
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elderly patients following hip surgery. Disabil Rehabil 2006; 28: 997-1005.
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48. Liberman K, Forti LN, Beyer I, Bautmans I. The effects of exercise on muscle strength, body composition, physical functioning and the inflammatory profile
30-53.
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of older adults: a systematic review. Curr Opin Clin Nutr Metab Care 2017; 20:
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49. Argilés JM, Campos N, Lopez-Pedrosa JM, Rueda R, Rodriguez-Mañas L. Skeletal Muscle Regulates Metabolism via Interorgan Crosstalk: Roles in Health and Disease. J Am Med Dir Assoc 2016; 17: 789-96. 50. Saturni S, Bellini F, Braido F, Paggiaro P, Sanduzzi A, Scichilone N,et al. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm Pharmacol Ther 2014; 27: 129-38
ACCEPTED MANUSCRIPT 51. Fiuza-Luces C, Garatachea N, Berger NA, Lucia A. Physiology (Bethesda). 2013; 28: 330-58. 52. Morley JE, Anker SD. Myopenia and precision (P4) medicine. J Cachexia Sarcopenia Muscle 2017 Sep 24. doi: 10.1002/jcsm. 53. Ramírez-Vélez R, Lobelo F, Izquierdo M. Exercise for Disease Prevention and
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Management: A Precision Medicine Approach. J Am Med Dir Assoc 2017;1 8:
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633-4.
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Table 1: Strength and power training progression of the multicomponent physical exercise program. 1
2
3
4
5
6
7
8
Repetitions
2x8
2x10
3x10
3x10
3x12
3x12
3x10
3x10
40%
40%
40%
40%
45%
45%
50%
50%
Session
9
10
11
13
14
15
16
Repetitions
3x10
3x12
3x12
3x12
2x8
2x10
3x10
3x10
50%
50%
55%
55%
60%
60%
60%
60%
18
19
20
21
22
23
24
3x6
3x8
3x4
3x6
3x6
3x6
3x4
3x4
65%
65%
70%
70%
70%
70%
75%
75%
Session
25
26
27
28
29
30
31
32
Repetitions
3x6
3x6
3x4
3x4
3x4
4x4
3x4
3x3
1RM
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per set
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Intensity
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(%1RM)
Second
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per set
17
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Session Repetitions
Intensity
12
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(%1RM)
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Intensity
Basal
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per set
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Sesion
1RM
(%1RM)
per set
ACCEPTED MANUSCRIPT Intensity
75%
75%
80%
80%
80%
80%
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NU
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(%1RM)
80%
80%
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Table 2: Basal characteristics of the sample. Sample finishing
sample
intervention
Mean (SD)
Mean (SD) n
or n (%) 77.3 (6.2)
Sex female
67
51 (76.1%)
BMI (kg/m2)
49
Fat free mass (kg)
44
50
n
Mean (SD) or n (%)
77.2 (5.8)
17
77.3 (7.5)
50
39 (78.0%)
17
12 (70.6%)
28.8 (4.3)
49
28.8 (4.3)
-
-
43.8 (7.3)
44
43.8 (7.3)
-
-
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67
Dropped out
or n (%)
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Age (years)
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n
Complete
44
26.2 (7.7)
44
26.2 (7.7)
-
44
37.0 (6.2)
44
37.0 (6.2)
-
-
Number of frailty phenotype criteria
67
2.0 (1.0)
50
2.1 (1.1)
17
1.8 (1.0)
Barthel index (score)
67
93.4 (8.5)
50
94.2 (7.0)
17
91.2 (12.1)
67
6.2 (2.0)
50
6.4 (2.0)
17
5.5 (1.9)
GDS Yesavage (score)
60
5.1 (3.0)
46
5.3 (3.1)
14
4.6 (3.0)
MMSE (score)
62
23.3 (4.1)
48
24.0 (3.9)
14
21.5 (3.5)
FES-I (score)
52
30.9 (10.8)
40
31.7 (11.2)
12
28.6 (9.2)
SPPB (score)
67
8.2 (2.6)
50
8.3 (2.5)
17
8.1 (3.0)
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Fat mass (kg)
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Fat mass (%)
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Lawton index (score)
ACCEPTED MANUSCRIPT 67
0.66 (0.18)
50
0.65 (0.18)
17
0.69 (0.20)
Balance subtest from SPPB (score)
67
3.4 (0.8)
50
3.4 (0.7)
17
3.2 (0.9)
5 sit-to-stand subtest SPPB (s)
67
15.2 (5.6)
50
14.9 (5.2)
17
16.1 (7.0)
1RM leg press strength (kg)
66
66.3 (27.4)
49
67.6 (27.9)
17
62.6 (26.6)
Q100 leg press power (W)
45
80.8 (47.3)
45
-
-
Q60 leg press power (W)
42
83.6 (47.6)
Hand grip strength (kg)
66
18.4 (7.5)
Number of patients with falls
67
Number of falls per patient
66
-
-
49
18.0 (6.9)
17
19.5 (9.2)
67 (100%)
50
50 (100%)
17
17 (100%)
3.8 (6.3)
49
3.3 (2.6)
17
5.1 (11.7)
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83.6 (47.6)
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80.8 (47.3)
42
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Gait speed (m/s)
ACCEPTED MANUSCRIPT Table 3: Results pre and post intervention
n
Post-
Mean difference
intervention
(95%CI)
p
49
28.8 (4.3)
28.9 (4.2)
01 (-01 to 0.4)
.262
Fat free mass (kg)
41
43.7 (7,2)
44.2 (7.3)
0.5 (0.1 to 1.0)
.034
Fat mass (%)
41
36.7 (6.3)
36.0 (6.8)
-0.7 (-1.4 to -0.1)
.023
Fat mass (kg)
41
25.9 (7.6)
0.5 (-0,1 to 1.1)
.116
Number of frailty phenotype
49
MMSE (score)
47
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-0.8 (-1.1 to -0.4)
1.3 (1.0)
.000
5.3 (3.1)
4.4 (2.8)
-0.9 (-1.7 to 0.1)
.023
24.0 (3.9)
24.7 (3.2)
0.7 (-0.3 to 1.7)
.175
FES-I (score)
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SPPB (score)
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46
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criteria
GDS Yesavage (score)
25.4 (7.9)
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2.1 (1.1)
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BMI (kg/m2)
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Baseline
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Gait speed (m/s)
Balance subtest from SPPB
40
31.7 (11.2)
28,5 (10.8)
-3.2 (-5.8 to -0.6)
.019
50
8.5 (4.0)
10.0 (3.0)
-
.000
50
0.65 (0.18)
0.82 (0.20)
0.16 (0.11 to 0.22)
.000
50
4.0 (1.0)
4.0 (0.0)
13.3 (7.4)
11.7 (5.3)
62.5 (32.3)
80.0 (45.0)
.012
(score)
5 sit-to-stand subtest from
48
.000
SPPB (s)
1RM leg press strength (kg)
46
-
.000
ACCEPTED MANUSCRIPT Q100 leg press power (W)
43
63.0 (66.0)
93.5 (82.0)
-
.000
Q60 leg press power (W)
40
76.0 (57.3)
119.0 (82.0)
-
.000
Hand grip strength (kg)
48
18.0 (6.9)
18.5 (6.1)
0.5 (-0.7 to 1.9)
.396
Number of patients with
50 50 (100%)
17 (34%)
3.0 (4.0)
0.0 (1.0)
49
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Number of falls per patient
-
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falls
-
-
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BMI (Body mass index); GDS (Geriatric Depression Scale); MMSE (Mini Mental State Examination); FES-I (Falls Efficiency Scale International); SPPB (Short Physical Performance
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Battery); 1RM (One Repetition Maximum). Q100: Leg-press power at 100% load. Q60: Leg-
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press power at 60% load. Data from SPPB, Balance subtest SPPB, 5 sit-to-stand test, 1RM leg press, Q100 leg press, Q60 leg press and Number of falls are expressed in medians (interquartile range), and significance is analyzed with Z Wilcoxon rank test, because of the non normal
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distribution. All the other variables are expressed in means (standard deviation) and analyzed
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with paired t-test. Number of patients with falls are analyzed with McNemar test.
ACCEPTED MANUSCRIPT
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Figure 1: Pre and post-intervention main physical function results
ACCEPTED MANUSCRIPT HIGHLIGHTS
A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with
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previous falls.
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Implementation of these strategies in hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations. Falls Units or Outpatient clinics-based short programs may increase self-confidence and
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adherence to exercise in non-exercising frail older adults before they join community-
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based or home-based programs.
Figure 1
Rafael García Molina, Marta Carolina Ruíz Grao, Alicia Noguerón García, Marta Martínez Reig, Mariano Esbrí Víctor, Míkel Izquierdo Redín, Pedro Abizanda Soler PII: DOI: Reference:
S0531-5565(18)30106-2 doi:10.1016/j.exger.2018.05.013 EXG 10365
To appear in:
Experimental Gerontology
Received date: Revised date: Accepted date:
13 February 2018 10 May 2018 15 May 2018
Please cite this article as: Rafael García Molina, Marta Carolina Ruíz Grao, Alicia Noguerón García, Marta Martínez Reig, Mariano Esbrí Víctor, Míkel Izquierdo Redín, Pedro Abizanda Soler , Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Exg(2017), doi:10.1016/ j.exger.2018.05.013
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ACCEPTED MANUSCRIPT Title: Benefits of a multicomponent Falls Unit-based exercise program in older adults with falls in real life. Running Title: Exercise in older adults with falls in real life.
Authors
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Rafael García Molina, Sport scientist, PhD. Geriatrics Department, Complejo
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Hospitalario Universitario de Albacete, Albacete, Spain.
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Marta Carolina Ruíz Grao, RN. Castilla-La Mancha University, Albacete, Spain. Alicia Noguerón García, MD. Geriatrics Department, Complejo Hospitalario
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Universitario de Albacete, Albacete, Spain.
Marta Martínez Reig, MD, PhD. Geriatrics Department, Complejo Hospitalario
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Universitario de Albacete, Albacete, Spain.
Mariano Esbrí Víctor, MD. Geriatrics Department, Complejo Hospitalario Universitario
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de Albacete, Albacete, Spain.
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Míkel Izquierdo Redín, PhD. Department of Health Sciences, Public University of Navarre, Tudela, Navarre, Spain. CIBER de Fragilidad y Envejecimiento Saludable
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(CB16/10/00315), Instituto de Salud Carlos III, Madrid, Spain. Pedro Abizanda Soler, MD, PhD. Head of the Geriatrics Department, Complejo
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Hospitalario Universitario de Albacete, Albacete, Spain. CIBER de Fragilidad y Envejecimiento Saludable, Instituto de Salud Carlos III, Madrid, Spain. Correspondence Pedro Abizanda Soler Hospital Perpetuo Socorro, C/ Seminario 4, 02006 Albacete, Spain Tel.: +34967597651 Fax: +34967597635 Email: [email protected]
ACCEPTED MANUSCRIPT ABSTRACT Background/Objectives: Multicomponent exercise programs are the cornerstone in preventing gait and balance impairments and falls in older adults. However, the effects of these programs in usual clinical practice have been poorly analyzed. Design: 4-month, twice-a-week multicomponent exercise program cohort study in real-
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life.
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Setting: Falls Unit, Complejo Hospitalario Universitario of Albacete, Spain.
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Participants: Sixty-seven participants who had experienced a fall in the previous year were included.
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Measurements: Pre- and post -intervention measurements were collected for leg press, gait speed, the Short Physical Performance Battery (SPPB), the Falls Efficiency Scale
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International, fat mass percentage, body mass index, the Geriatric Depression Scale by Yesavage (GDS), the Mini Mental State Examination, and the number of falls.
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Results: Fifty participants completed the program (adherence rate 75%, attendance
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80%). Their mean age was 77.2 (SD 5.8) years; 39 were women. The participants reduced the mean number of frailty criteria from 2.1 to 1.3. (95%CI 0.4-1.1) and
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increased mean gait speed from 0.65 m/s to 0.82 m/s (95%CI 0.11-0.22), increasing their median SPPB scores from 8.5 to 10.0 points (p<0.001), leg press strength from
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62.5 kg to 80.0 kg (p<0.001), and leg press power at 60% load from 76 W to 119 W (p<0.001). There was also an improvement in GDS scores from 5.3 to 4.4 (95%CI 0.11.7). Body mass index did not change, but fat-free mass increased from 43.7 kg to 44.2 kg (95%CI 0.1.-1.0), and fat mass percentage declined from 36.7% to 36.0% (95% CI 0.1-1.4). Seventeen patients (34%) had a fall during the six-month follow-up, and there was a reduction in the median number of falls from 3.0/year to 0.0/six months.
ACCEPTED MANUSCRIPT Conclusions: A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with previous falls.
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Key words: Multicomponent Exercise Program, Falls, Older adults, Usual care,
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Physical function
ACCEPTED MANUSCRIPT INTRODUCTION Several recent systematic reviews and meta-analyses have demonstrated that physical exercise is the gold standard treatment for functional improvement in older adults (1-5). Different exercise modalities such as strength, balance, cardiovascular and coordination, have demonstrated functional benefits in frail older adults, although
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multicomponent exercise programs that specifically include strength and power,
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endurance and balance training present a better profile (6-12). Moreover,
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multicomponent exercise programs that include strength and power training have added benefits for cardiovascular and respiratory function; cognitive and affective status;
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increased socialization; and reduced frailty, sarcopenia, falls and fear of falling syndrome (13-17). For these reasons, some authors question the ethics of not
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prescribing physical exercise when frailty is determined in older adults (18). Two physical exercise implementation strategies have been described in frail
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older adults (19). The first is based on home programs in which physical exercise
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experts teach older adults how to conduct the program by themselves at home (13,20), the participants perform physical exercise with direct expert supervision at home (21),
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or the participants follow well-structured programs such as VIVIFRAIL with telematic aids by themselves (22,23). In the second strategy, physical exercise programs are
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directly administered by specialists in this discipline who adapt the type, intensity, frequency and length of the programs to specialized individual needs in controlled spaces (17). Although this last strategy could seem less efficient from an economic approach, it is usually the most effective strategy for older populations (24-26). Until now, most of the published studies on physical exercise in older adults have been randomized clinical trials or have been performed under experimental conditions, but data regarding the real-life results of physical exercise programs among
ACCEPTED MANUSCRIPT older adults with different conditions, such as falls, and in different settings, such as Falls Units at hospitals, are lacking. For this reason, we decided to present the results of two first-years programs in the Multicomponent Physical Exercise Unit at our Falls Unit for frail older adults or older adults who have experienced falls.
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METHODS
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Design
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This was a retrospective study under usual clinical practice conditions conducted in real life, to describe the results of a multicomponent physical exercise program in
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patients older than 64 years with previous falls.
Every participant underwent a basal assessment in the Falls Unit including a
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complete falls history, physical examination, posturography (Neurocom Balance Master, NeuroCom® International, Inc., Clackamas, U.S.A.), gait analysis using
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GaitRite (GAIT Rite Portable Walkway System 427P, CIR Systems, Inc, Franklin, NJ,
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U.S.A.), grip strength measurement (Jamar digital dynamometer, NexGen ergonomics, Pointe Claire, Quebec, Canada), one repetition maximum (1RM) seated leg press
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strength (BH Exercycle X050, Exercycle SL, Vitoria-Gasteiz, Spain), leg press power (T-Force Dynamic Measurement System, Ergotech Consulting SL, Murcia, Spain), in
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the same order with a 3-minute rest between tests in order to diminish fatigue (27), and blood analysis to determine the medical conditions responsible for falls and to determine a management strategy. At the second visit, the patients received a complete diagnosis and medical treatment to reduce the risk and consequences of falls. All patients who were able to walk with or without technical aids (canes or a walker) without personal help were invited to participate in a multicomponent physical exercise program under usual clinical care conditions.
ACCEPTED MANUSCRIPT After finishing the program, all the patients attended a third medical visit aimed at analyzing the results of the program. At six months after the beginning of the intervention, the patients were asked about the occurrence of falls. Patients had been previously trained to register any incident fall during the follow-up period. This procedure represents the usual clinical practice at our Falls Unit.
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“The usual clinical practice at the Falls Unit is based on a comprehensive
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multifactorial assessment of older adults with falls. History of falls, risk factors, drugs,
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frailty and sarcopenia are evaluated. Complete clinical examination, balance analysis with static and dynamic posturography, and gait analysis is performed. Interventions
and
osteoporosis
treatment,
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are individualized according to the findings, including polypharmacy control, vitamin D ophthalmology
referral,
home
environmental
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recommendations, nutritional interventions, and physical exercise as needed.”
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Setting and study subjects
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We included 67 consecutive patients older than 64 years from the community at the Falls Unit of the Complejo Hospitalario Universitario of Albacete. The included
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patients had had at least one fall in the last year and were able to walk with or without technical aids (canes or a walker). All the patients agreed to participate in the program.
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At the baseline visit, we excluded patients who were unable to perform any of the exercises in the program or to understand the instructions given by the sport scientist who conducted the sessions.
Multicomponent Physical Exercise Program The intervention consisted of a twice-a-week, 4-month (32 sessions) multicomponent physical exercise program. The main objective of the program was to
ACCEPTED MANUSCRIPT achieve an improvement in physical function that would reduce future falls. The program was conducted by a sport scientist with the help of a trained nurse. In the first session, the patients completed a modified Senior Fitness Test battery for measuring basal functional fitness (28), including upper and lower limb strength, flexibility, agility, and endurance. We also determined the leg press1RM, leg press
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power, gait speed, and grip strength.
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An individualized multicomponent physical exercise program was designed for
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every patient according to the basal functional level, comorbidities, and previous exercise experience. Individualization was based on the modified Senior Fitness Test
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battery results, adjusting load and intensity to allow a maximum of 30 repetitions for each exercise. Complexity of exercises was also adapted to cognitive status, preferences
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and previous experience of participants. The strength and power program was based on previous work resistance training approaches for older adults (Table 1). It begins with
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low-intensity, high-repetition sessions, ending with high-intensity, low-repetition
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sessions. The patients were asked to perform a combined maximal/explosive resistance training program to improve both strength and power (29,30). In addition to strength
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and power exercises with machines, we included general strength exercises with bands, dumbbells and elastic bands and balance exercises. Moreover, agility, coordination and
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dual-task exercises were included. The sessions ended with flexibility and stretching exercises to cool down. This exercise program was based on the VIVIFRAIL multicomponent physical exercise program to prevent weakness and the risk of falling (22,23). The length of the sessions was 45 minutes approximately, divided in three different parts: a warm-up (10 to 15 minutes); the main exercise program (20 to 25 minutes) consisting on four to six different exercises with 2 to 4 series per each one, a
ACCEPTED MANUSCRIPT recover between series of 30-60 seconds, and a recover between exercises of 60 to 90 seconds; finally return to calm (5 to 10 minutes) with stretching of the main muscle groups and quiet breaths to reduce heart frequency.
Result variables
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Pre and post measures of the following variables were collected: Frailty
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phenotype (31); disability in basic activities of daily living (BADL), assessed with the
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Barthel index (32), and in instrumental activities of daily living (IADL), assessed with the Lawton index (33); fear of falling, assessed with the Falls Efficiency Scale -
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International (FES-I) (34); affective status, assessed with the Geriatric Depression Scale (GDS) by Yesavage (35); and cognitive status, assessed with Folstein´s Mini Mental
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State Evaluation (MMSE) (36). Body composition was determined using body mass index (BMI), fat-free mass (FFM) and the percentage of fat mass, determined with
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bioimpedanciometry (BC-418 Segmental Body Composition Tanita Instrument, Tanita,
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Tokyo, Japan). Physical function was measured with the Short Physical Performance Battery (SPPB) (37), and the three subtests of this battery (gait speed, balance and 5-sit-
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to-stand test) were also independently analyzed. The hand grip strength, 1RM seated leg press strength, and leg press power at 60% (Q60) and 100% (Q100) of 1RM, that means
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60% and 100% of 1RM, were also determined. The 60% 1RM leg press power is within the range observed in the literature that elucidates the maximal power output in older adults on the leg press exercise (27). Three sets of one to three repetitions per load, performed over several representative loads (<50%, 50%–80%, and >80% 1RM, or by a body mass-based incremental protocol), might be optimal to assess muscle power in older adults (27,38). Finally, the participants were asked about the number of falls in the
ACCEPTED MANUSCRIPT previous year, during the exercise program and 6 months from the beginning of the program.
Ethical aspects Our research was conducted in accordance with the Helsinki statement regarding
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human research. The retrospective analysis study was approved by the Ethics Review
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Committee of the Complejo Hospitalario Universitario of Albacete. It was not necessary
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for the participants to give written consent because the program was performed under usual clinical practice conditions in real life. However, all the participants agreed to
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participate in the program and were informed about the conditions and risks, although
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the protocol was part of the usual care for intervention on frailty and falls prevention.
Statistics
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A descriptive analysis was performed. The normal distribution of variables was
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determined by Kolmogorov-Smirnoff test. Results for normally distributed variables are presented by means (standard deviation), and for variables not meeting normal
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distribution the median with the interquartile range is presented. The comparison of the pre- and post-intervention variables following normal distribution were compared using
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paired t-tests with 95% confidence interval (CI) for the means, and in variables not meeting normal distribution criteria Z Wilcoxon rank test for median differences was used. As a result, data from SPPB, Balance subtest SPPB, 5 sit-to-stand test, 1RM leg press, Q100 leg press, Q60 leg press and number of falls are expressed in medians (interquartile range), and significance is analyzed with Z Wilcoxon rank test. All the other variables are expressed in means (standard deviation) and analyzed with paired ttest. Differences in the number of patients with falls and falls/person during the follow-
ACCEPTED MANUSCRIPT up period were described, but no statistical analysis was undertaken because of the absence of a control group. The data were analyzed with SPSS 22.0.
RESULTS We included 67 participants, 50 completed the physical exercise intervention,
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and 17 dropped out at various points in the program, for an adherence rate of 75%, and
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a mean attendance of 80% to the sessions. All participants received intervention with
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vitamin D correction and polypharmacy control, and 20% nutritional intervention. Table 2 presents the baseline characteristics of the complete sample, those who finished the
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intervention program, and those who dropped out. The mean age of the participants who completed the program was 77.2 years (SD 5.8; range 66-88). Most important
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comorbidities were from the circulatory system (91.0%), locomotor system (70.1%), vision (46.3%), nervous system (34.3%) and respiratory system (26.9%), and the most
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prevalent diseases were osteoarthritis 29.9%, diabetes 26.9%, hypertension 23.9%,
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osteoporosis 23.9%, and depression 16.4%. There were no baseline differences between the participants who finished the
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exercise program and those who dropped out in terms of age, female sex, SPPB, number of frailty criteria, hand grip strength and 1RM leg press strength, although the
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participants who finished the program had fewer falls in the previous year than those who dropped out (3.3 and 5.1 mean falls per participant in the previous year respectively). However, one participant who dropped out had 50 falls in the previous year, biasing the mean number of falls in this group. After excluding this patient, the number of falls was 2.3 (SD 1.4), without statistical difference compared to those who finished the program. Because there were no significant differences between
ACCEPTED MANUSCRIPT participants who finished or drop out the program, we decided not to weight the results (39). Table 3 presents the pre- and post-intervention results. The number of frailty criteria decreased from 2.1 per participant to 1.3 (a reduction of 0.8 criteria per participant; 95% CI 0.4-1.1). The Yesavage GDS scores improved from 5.3 to 4.4
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differences in cognitive status before and after the program.
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points per participant (reduction in 0.9 points; 95% CI 0.1-1.7). We found no
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Although the BMI did not change significantly across the program, there was a 0.5 kg increase in FFM per participant (95% CI 0.1-1.0) from 43.7 kg to 44.2 kg with a
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decrease in fat mass from 25.9 kg to 25.4 kg, and consequently a decrease in fat mass percentage from 36.7% to 36.0% (reduction of 0.7%; 95% CI 0.1-1.4).
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Regarding the physical function variables, the participants who finished the program showed improved SPPB median scores, from 8.5 to 10.0, and there was an
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improvement in the mean gait speed subtest of the SPPB from 0.65 m/s to 0.82 m/s
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(increase in 0.17 m/s; 95% CI 0.11-0.22), and median 5 sit-stands subtest of the SPPB from 13.3 sec. to 11.7 sec. There was also an increase in median 1RM leg press strength
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from 62.5 kg to 80.0 kg, and an increasing trend in hand grip strength from 18.0 kg to 18.5 kg (increase of 0.5 kg; 95% CI -0.7-1.9). Regarding leg-press power, there was an
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increase in median Q100 (100% load) of 30.5 W, from 63.0 to 93.5, and in Q60 (60% load) of 43 W from 76.0 to 119.0. Figure 1 presents the main results of physical function tests. Among the 50 participants who finished the program, only 17 (34%) reported a new fall in the 6 months since the study began, and only one participant developed a new fracture. The median number of falls per participant decreased from 3.0 to 0.0 during this follow-up period.
ACCEPTED MANUSCRIPT DISCUSSION Our results show that a Falls Unit-based multicomponent exercise program as part of usual clinical practice in real life in older adults with a previous fall improves physical function, body composition, and affective status and shows a possible reduction in the number of falls. Our work adds to previous knowledge that in selected
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frail populations with previous falls, a Falls Unit-based exercise program directed
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toward improving muscle strength and power is an efficient clinical intervention that
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could be implemented in real life.
Previous meta-analyses have demonstrated that multicomponent group exercise
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significantly reduced the rate of falls (rate ratio [RaR] 0.71, 95% CI 0.63 to 0.82; 16 trials; 3,622 participants) and the risk of falling (risk ratio [RR] 0.85, 95% CI 0.76 to
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0.96; 22 trials; 5,333 participants), as did multicomponent home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; 7 trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94;
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6 trials; 714 participants) (40). In our exercise group, we observed an absolute falls risk
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reduction of 0.34, greater than in previous studies, probably secondary to the characteristics of our participants, a high risk of falls frail population.
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Previous work of Casas Herrero et al. stated that multicomponent exercise programs are the most complete method for improving physical function in frail older
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adult populations (41). These types of programs, which include strength, power and balance exercises, are directed towards physical conditioning, unlike those that only include one modality, such as balance or strength, and only accomplish benefits in that domain. Furthermore, programs that include power training seem to produce greater benefits than those that only include strength exercises because they also improve cardiovascular and respiratory function (42,43). For this reason we decided to include this kind of program as usual clinical practice at our Falls Unit. Our clinical group not
ACCEPTED MANUSCRIPT only improved strength and physical function with this program, but also presented an important increase in leg press power, a more functionally relevant measure of muscle performance than strength (44). Physical exercise in older adults can be implemented in hospital settings, institutions or in the community, but there is little information comparing the efficiency
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of both three settings in frail and faller older adults. In a systematic review (45), only 1
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out of 9 included randomized clinical trials was conducted in a teaching hospital (46),
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not allowing for comparisons. Another study showed more positive health outcomes in supervised/class-based groups in hip fracture older adults than in non-supervised/home-
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based groups (47). The rationale for conducting our program in a hospital setting was to break the negative feed-back of fear of falling and deconditioning in this population
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through a supervised and healthcare protective environment, with a close access to geriatricians and nurses.
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Our program also improved body composition with an increase in fat-free mass
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and a decrease in fat mass. Resistance and power exercise can increase the type I and type II muscle fiber cross-sectional area and lean muscle mass through enhanced muscle
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protein synthesis, anabolic hormone production, satellite cell activation, and reduction of catabolic cytokines (48). It has also been described that more than for physical
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movement, for posture and vital actions, such as chewing, swallowing, and breathing, skeletal muscle also serves as a regulator of interorgan crosstalk for energy and protein metabolism throughout the body, leading not only to functional benefits but also to metabolic benefits (49). It could be argued that the main limitation of our work is the absence of a control group or that the design is not a randomized clinical trial. Although this is true, our findings are in agreement with previous evidence that physical exercise is the gold
ACCEPTED MANUSCRIPT standard treatment for frail older adults and adults with previous falls and that it is not ethical not to prescribe exercise programs for these populations (18). For this reason, the inclusion of control (placebo) groups could be not ethic. Against this background, observational, real-life studies performed under usual clinical practice conditions are mandatory to ascertain that the results of clinical trials can be replicated in real life. The
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European Working Group on Relative Effectiveness has defined real life studies as a
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way to analyze medical data collected under real life conditions, in everyday settings, providing insights into the real life effectiveness of a medical condition/intervention.
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Randomized controlled trials are the “gold standard” for evaluating treatment outcomes
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providing information on treatments “efficacy”, designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason
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they have high internal validity, although the strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in
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conditions very different from real life usual care. However, real life studies describe
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the “effectiveness” of a treatment, allowing for a high generalizability, but low internal validity. The comparison of effectiveness and efficacy studies can provide important
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information about interventions. Both approaches can result complementary, and may guide the interpretation of each other results leading to better clinical decisions (50).
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Another limitation could be the small sample size. However, in the case of frail older adults, the number of participants per group must be small (four to six participants per session maximum) to avoid falls and injuries and increase adherence. For this reason, it is difficult to obtain a large number of participants in a short time. However, the results for our patients were so impressive and similar to those of previous clinical trials, that the sample size was large enough to demonstrate that these programs can be
ACCEPTED MANUSCRIPT effectively implemented in settings with similar characteristics to ours, a teaching hospital with a complete Geriatrics Department. The last limitation of the study could be that physical tests assessment could produce fatigue, biasing the results of the last ones. For this reason tests were performed always in the same order (from low to high metabolic demand), and adequate recovery
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intervals were allowed between them (27). We can´t absolutely confirm that benefits of
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the intervention were solely related to physical exercise because a comprehensive
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geriatric evaluation with clinical interventions was also implemented in the Falls Unit. However, all participants were included in the physical exercise program after a one-to-
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four month period after the clinical visit, thus allowing for a stabilization of medical problems before doing the pre-intervention assessment.
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Although pharmaceutical are the gold standard treatment for almost all medical conditions, an unique finding of the present study was that a Falls Unit-based physical
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exercise program induce positive functional and clinical benefits for frail older patients
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with falling risk. After our experience, we agree with previous authors that the implementation of these strategies in teaching hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations (51). Short Falls Units or Outpatient clinics-based programs may increase self-confidence and
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adherence to exercise in non-exercising frail older adults before they join communitybased or home-based programs (22,23). However, further analysis of other subgroups of older adults and different exercise modalities or intensities could be necessary to find the best approach for every individual using a precision medicine approach (52,53).
ACCEPTED MANUSCRIPT CONCLUSIONS A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with previous falls.
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Implementation of these strategies in hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations. Falls
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Units or Outpatient clinics-based short programs may increase self-confidence and adherence to exercise in non-exercising frail older adults before they join community-
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based or home-based programs.
ACCEPTED MANUSCRIPT DISCLOSURES / CONFLICT OF INTEREST All authors declare that there are no conflicts of interest.
STATEMENT OF AUTHORSHIP P. Abizanda, M. Esbrí and M. Martínez-Reig participated in the study concept
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development as well as the study design, protocol writing and reviewing process. All
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authors participated in the study take-off. R. García-Molina and M.C. Ruíz-Grao
Noguerón analyzed the study results.
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participated in data collection and management. P. Abizanda, M. Esbrí and A. M. Izquierdo reviewed the manuscript, and
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helped with data interpretation and counseling. All authors reviewed and approved the
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final manuscript.
ACKNOWLEDGMENTS
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This work was supported by CIBERFES, Instituto de Salud Carlos III, Ministerio de
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Economía y Competitividad, España. Ayuda cofinanciada por el Fondo Europeo de
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Desarrollo Regional FEDER Una Manera de hacer Europa.
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review of randomized controlled trials. BMC Geriatr 2015; 15: 154.
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46. Latham NK, Anderson CS, Lee A, Bennett DA, Moseley A, Cameron ID, et al. A randomized, controlled trial of quadriceps resistance exercise and vitamin D
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in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). J Am Geriatr Soc 2003; 51: 291-9.
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47. Carmeli E, Sheklow SL, Coleman R. A comparative study of organized classbased exercise programs versus individual home-based exercise programs for
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elderly patients following hip surgery. Disabil Rehabil 2006; 28: 997-1005.
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48. Liberman K, Forti LN, Beyer I, Bautmans I. The effects of exercise on muscle strength, body composition, physical functioning and the inflammatory profile
30-53.
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of older adults: a systematic review. Curr Opin Clin Nutr Metab Care 2017; 20:
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49. Argilés JM, Campos N, Lopez-Pedrosa JM, Rueda R, Rodriguez-Mañas L. Skeletal Muscle Regulates Metabolism via Interorgan Crosstalk: Roles in Health and Disease. J Am Med Dir Assoc 2016; 17: 789-96. 50. Saturni S, Bellini F, Braido F, Paggiaro P, Sanduzzi A, Scichilone N,et al. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm Pharmacol Ther 2014; 27: 129-38
ACCEPTED MANUSCRIPT 51. Fiuza-Luces C, Garatachea N, Berger NA, Lucia A. Physiology (Bethesda). 2013; 28: 330-58. 52. Morley JE, Anker SD. Myopenia and precision (P4) medicine. J Cachexia Sarcopenia Muscle 2017 Sep 24. doi: 10.1002/jcsm. 53. Ramírez-Vélez R, Lobelo F, Izquierdo M. Exercise for Disease Prevention and
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Management: A Precision Medicine Approach. J Am Med Dir Assoc 2017;1 8:
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633-4.
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Table 1: Strength and power training progression of the multicomponent physical exercise program. 1
2
3
4
5
6
7
8
Repetitions
2x8
2x10
3x10
3x10
3x12
3x12
3x10
3x10
40%
40%
40%
40%
45%
45%
50%
50%
Session
9
10
11
13
14
15
16
Repetitions
3x10
3x12
3x12
3x12
2x8
2x10
3x10
3x10
50%
50%
55%
55%
60%
60%
60%
60%
18
19
20
21
22
23
24
3x6
3x8
3x4
3x6
3x6
3x6
3x4
3x4
65%
65%
70%
70%
70%
70%
75%
75%
Session
25
26
27
28
29
30
31
32
Repetitions
3x6
3x6
3x4
3x4
3x4
4x4
3x4
3x3
1RM
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per set
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Intensity
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(%1RM)
Second
AC
per set
17
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Session Repetitions
Intensity
12
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(%1RM)
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Intensity
Basal
SC
per set
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Sesion
1RM
(%1RM)
per set
ACCEPTED MANUSCRIPT Intensity
75%
75%
80%
80%
80%
80%
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SC
RI
PT
(%1RM)
80%
80%
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Table 2: Basal characteristics of the sample. Sample finishing
sample
intervention
Mean (SD)
Mean (SD) n
or n (%) 77.3 (6.2)
Sex female
67
51 (76.1%)
BMI (kg/m2)
49
Fat free mass (kg)
44
50
n
Mean (SD) or n (%)
77.2 (5.8)
17
77.3 (7.5)
50
39 (78.0%)
17
12 (70.6%)
28.8 (4.3)
49
28.8 (4.3)
-
-
43.8 (7.3)
44
43.8 (7.3)
-
-
RI
67
Dropped out
or n (%)
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Age (years)
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n
Complete
44
26.2 (7.7)
44
26.2 (7.7)
-
44
37.0 (6.2)
44
37.0 (6.2)
-
-
Number of frailty phenotype criteria
67
2.0 (1.0)
50
2.1 (1.1)
17
1.8 (1.0)
Barthel index (score)
67
93.4 (8.5)
50
94.2 (7.0)
17
91.2 (12.1)
67
6.2 (2.0)
50
6.4 (2.0)
17
5.5 (1.9)
GDS Yesavage (score)
60
5.1 (3.0)
46
5.3 (3.1)
14
4.6 (3.0)
MMSE (score)
62
23.3 (4.1)
48
24.0 (3.9)
14
21.5 (3.5)
FES-I (score)
52
30.9 (10.8)
40
31.7 (11.2)
12
28.6 (9.2)
SPPB (score)
67
8.2 (2.6)
50
8.3 (2.5)
17
8.1 (3.0)
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Fat mass (kg)
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Fat mass (%)
AC
Lawton index (score)
ACCEPTED MANUSCRIPT 67
0.66 (0.18)
50
0.65 (0.18)
17
0.69 (0.20)
Balance subtest from SPPB (score)
67
3.4 (0.8)
50
3.4 (0.7)
17
3.2 (0.9)
5 sit-to-stand subtest SPPB (s)
67
15.2 (5.6)
50
14.9 (5.2)
17
16.1 (7.0)
1RM leg press strength (kg)
66
66.3 (27.4)
49
67.6 (27.9)
17
62.6 (26.6)
Q100 leg press power (W)
45
80.8 (47.3)
45
-
-
Q60 leg press power (W)
42
83.6 (47.6)
Hand grip strength (kg)
66
18.4 (7.5)
Number of patients with falls
67
Number of falls per patient
66
-
-
49
18.0 (6.9)
17
19.5 (9.2)
67 (100%)
50
50 (100%)
17
17 (100%)
3.8 (6.3)
49
3.3 (2.6)
17
5.1 (11.7)
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83.6 (47.6)
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80.8 (47.3)
42
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Gait speed (m/s)
ACCEPTED MANUSCRIPT Table 3: Results pre and post intervention
n
Post-
Mean difference
intervention
(95%CI)
p
49
28.8 (4.3)
28.9 (4.2)
01 (-01 to 0.4)
.262
Fat free mass (kg)
41
43.7 (7,2)
44.2 (7.3)
0.5 (0.1 to 1.0)
.034
Fat mass (%)
41
36.7 (6.3)
36.0 (6.8)
-0.7 (-1.4 to -0.1)
.023
Fat mass (kg)
41
25.9 (7.6)
0.5 (-0,1 to 1.1)
.116
Number of frailty phenotype
49
MMSE (score)
47
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-0.8 (-1.1 to -0.4)
1.3 (1.0)
.000
5.3 (3.1)
4.4 (2.8)
-0.9 (-1.7 to 0.1)
.023
24.0 (3.9)
24.7 (3.2)
0.7 (-0.3 to 1.7)
.175
FES-I (score)
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SPPB (score)
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criteria
GDS Yesavage (score)
25.4 (7.9)
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2.1 (1.1)
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BMI (kg/m2)
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Baseline
AC
Gait speed (m/s)
Balance subtest from SPPB
40
31.7 (11.2)
28,5 (10.8)
-3.2 (-5.8 to -0.6)
.019
50
8.5 (4.0)
10.0 (3.0)
-
.000
50
0.65 (0.18)
0.82 (0.20)
0.16 (0.11 to 0.22)
.000
50
4.0 (1.0)
4.0 (0.0)
13.3 (7.4)
11.7 (5.3)
62.5 (32.3)
80.0 (45.0)
.012
(score)
5 sit-to-stand subtest from
48
.000
SPPB (s)
1RM leg press strength (kg)
46
-
.000
ACCEPTED MANUSCRIPT Q100 leg press power (W)
43
63.0 (66.0)
93.5 (82.0)
-
.000
Q60 leg press power (W)
40
76.0 (57.3)
119.0 (82.0)
-
.000
Hand grip strength (kg)
48
18.0 (6.9)
18.5 (6.1)
0.5 (-0.7 to 1.9)
.396
Number of patients with
50 50 (100%)
17 (34%)
3.0 (4.0)
0.0 (1.0)
49
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Number of falls per patient
-
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falls
-
-
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BMI (Body mass index); GDS (Geriatric Depression Scale); MMSE (Mini Mental State Examination); FES-I (Falls Efficiency Scale International); SPPB (Short Physical Performance
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Battery); 1RM (One Repetition Maximum). Q100: Leg-press power at 100% load. Q60: Leg-
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press power at 60% load. Data from SPPB, Balance subtest SPPB, 5 sit-to-stand test, 1RM leg press, Q100 leg press, Q60 leg press and Number of falls are expressed in medians (interquartile range), and significance is analyzed with Z Wilcoxon rank test, because of the non normal
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distribution. All the other variables are expressed in means (standard deviation) and analyzed
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with paired t-test. Number of patients with falls are analyzed with McNemar test.
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Figure 1: Pre and post-intervention main physical function results
ACCEPTED MANUSCRIPT HIGHLIGHTS
A multicomponent Falls Unit-based exercise program as part of usual clinical practice in real life, improved physical function, reduced depressive symptoms, improved body composition and decreased the number of falls in older adults with
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previous falls.
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Implementation of these strategies in hospitals should be mandatory to
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empower frail older adults with exercise, “the best pill” for these populations. Falls Units or Outpatient clinics-based short programs may increase self-confidence and
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adherence to exercise in non-exercising frail older adults before they join community-
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based or home-based programs.
Figure 1