A Home- and Community-Based Physical Activity Program Can Improve the Cardiorespiratory Fitness and Walking Capacity of Stroke Survivors

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A Home- and Community-Based Physical Activity Program Can Improve the Cardiorespiratory Fitness and Walking Capacity of Stroke Survivors Dianne Lesley Marsden, BAppSci(Physiotherapy), MAppMgnt(Health), PhD,*†‡ Ashlee Dunn, BExSpSci(Hon),§‖ Robin Callister, BPharm, MSc, PhD,§‖ Patrick McElduff, BMath, PhD,¶ Christopher Royce Levi, MBBS, BMedSci, FRACP, FAHMS,‡**†† and Neil James Spratt, FRACP, PhD‡‡‡§§

Background: The cardiorespiratory fitness of stroke survivors is low. Center-based exercise programs that include an aerobic component have been shown to improve poststroke cardiorespiratory fitness. This pilot study aims to determine the feasibility, safety, and preliminary efficacy of an individually tailored home- and communitybased exercise program to improve cardiorespiratory fitness and walking capacity in stroke survivors. Methods: Independently ambulant, community-dwelling stroke survivors were recruited. The control (n = 10) and intervention (n = 10) groups both received usual care. In addition the intervention group undertook a 12-week, individually tailored, home- and community-based exercise program, including onceweekly telephone or e-mail support. Assessments were conducted at baseline and at 12 weeks. Feasibility was determined by retention and program participation, and safety by adverse events. Efficacy measures included change in cardiorespiratory

From the *School of Medicine and Public Health and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Callaghan, New South Wales, Australia; †Hunter Stroke Service, Hunter New England Local Health District, New Lambton Heights, New South Wales, Australia; ‡Brain and Mental Health Program, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia; §School of Biomedical Sciences and Pharmacy and Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; ‖Cardiovascular Research, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia; ¶School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; **Clinical Research & Translation and Neurology Department at John Hunter Hospital, Hunter New England Local Health District, New Lambton Heights, New South Wales, Australia; ††Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Callaghan, New South Wales, Australia; ‡‡School of Biomedical Sciences and Pharmacy and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Callaghan, New South Wales, Australia; and §§Neurology Department at John Hunter Hospital, Hunter New England Local Health District, New Lambton Heights, New South Wales, Australia. Received March 30, 2016; revision received May 23, 2016; accepted June 3, 2016. Grant support: This research has been supported by small project grants from the National Stroke Foundation, the John Hunter Hospital Charitable Trust, the Hunter New England Allied Health Research Committee Research Fund, and Hunter Medical Research Institute: Estate of the late Stephen James Fairfax Award (HMRI 13-55). D.L.M. was supported by the Heart Foundation (PB 10S 5518) and the University of Newcastle through the provision of a postgraduate scholarship and by the Hunter Stroke Service. A.D. was supported by the University of Newcastle through an Australian Postgraduate Award Scholarship and through a Hunter Medical Research Institute Emlyn and Jennie Thomas Postgraduate Medical Research Scholarship. N.J.S. was supported by a Career Development Fellowship (APP1035465) from the Australian National Health and Medical Research Council. This funding has in no way influenced how the study was designed, conducted, or reported. Address correspondence to Dianne Lesley Marsden, PhD, Hunter Stroke Service, Level 2, The Lodge, Rankin Park Campus, Lookout Road, New Lambton Heights 2305, NSW, Australia. E-mail: [email protected]. 1052-3057/$ - see front matter © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2016.06.007

Journal of Stroke and Cerebrovascular Diseases, Vol. ■■, No. ■■ (■■), 2016: pp ■■–■■

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fitness (peak oxygen consumption [VO2peak]) and distance walked during the Six-Minute Walk Test (6MWT). Analysis of covariance was used for data analysis. Results: All participants completed the study with no adverse events. All intervention participants reported undertaking their prescribed program. VO2peak improved more in the intervention group (1.17 ± .29 L/min to 1.35 ± .33 L/min) than the control group (1.24 ± .23 L/min to 1.24 ± .33 L/min, between-group difference = .18 L/min, 95% confidence interval [CI]: .01-.36). Distance walked improved more in the intervention group (427 ± 123 m to 494 ± 67m) compared to the control group (456 ± 101m to 470 ± 106m, between-group difference = 45 m, 95% CI: .3-90). Conclusions: Our individually tailored approach with once-weekly telephone or e-mail support was feasible and effective in selected stroke survivors. The 16% greater improvement in VO2peak during the 6MWT achieved in the intervention versus control group is comparable to improvements attained in supervised, center-based programs. Key Words: Stroke—cardiorespiratory fitness—exercise—home program—walking capacity. © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Introduction The cardiorespiratory fitness of stroke survivors is low1,2 with peak oxygen consumption (VO2peak) values ranging from 26% to 87% of those of healthy age- and gendermatched individuals.2 It has been estimated that over three quarters of people after stroke have low levels of physical activity or are sedentary.3 Stroke survivors spend a large proportion of their day (median = 19.5 hours, 81%) in sedentary behaviors, often accumulated via prolonged bouts of inactivity (median = 1.7 hours).4 Stroke survivors spend 4 hours more per day in sedentary behavior than age-, sex-, and body mass index-matched healthy volunteers.5 Low levels of cardiorespiratory fitness and physical activity and high levels of sedentary time can reduce the ability to perform activities of daily living and may contribute to an increased risk for recurrent stroke and other cardiometabolic diseases.6 Exercise programs that include an aerobic component have been shown to improve cardiorespiratory fitness,1,7-9 walking speed8,9 and walking endurance.8-10 Even modest amounts of aerobic training can improve cardiorespiratory fitness by 10%-15%.1 Of the 28 studies included in a recent systematic review, 25 used multiple sessions of center-based supervised training each week1; 2 studies used once-weekly center-based supervised sessions in conjunction with a home program; and 1 study used a oneon-one therapist-supervised home program.1 For safety reasons supervised cardiorespiratory fitness training programs may be required for stroke survivors with significant impairments or multiple comorbidities. Programs providing ongoing support with little or no face-to-face supervision may offer a safe and effective alternative. Such programs may address the unmet needs of more independent stroke survivors and can provide an option for health services where limited, if any, community-based therapy services are available. Recent audit data indicate that 44% of stroke survivors were discharged directly home from the acute setting, with only 31% subsequently accessing rehabilitation.11 Although these

people might have minimal mobility issues, they may benefit from ongoing interventions to maintain or improve their cardiorespiratory fitness and to reduce their sedentary behavior. The need for studies of home-based programs with intermittent supervision has been recognized in a recent review, particularly to provide evidence for therapies that may help stroke survivors who live away from major centers.12 Individualizing exercise programs to suit each person’s ability is particularly pertinent to stroke survivors, given the heterogeneity of abilities in this population due to the effects of stroke and the wide age range over which stroke occurs. Individual tailoring also allows participants to engage in activities that are of interest to them.13 The aims of the present pilot study were to determine the feasibility, safety, and preliminary efficacy of an individually tailored, home- and community-based exercise program to improve cardiorespiratory fitness in stroke survivors. The effects on performance measures, fatigue, depression, and health-related quality of life were also investigated to guide the design of a future larger, randomized controlled trial.

Materials and Methods Study Design A pilot controlled trial was undertaken to investigate the effects of a 12-week exercise intervention on communitydwelling stroke survivors (“How Fit is the Stroke Survivor?” [HowFITSS?] trial ANZCTR Trial ID: ACTRN12614000134628). Participants in both the control and intervention groups received usual care, and the intervention group also undertook the HowFITSS? exercise program. All participants were assessed at baseline and at 12 weeks.

Ethics Statement The Hunter New England (11/04/20/4.04) and the University of Newcastle (H-2011-0172) Human Research Ethics Committees approved the study, which was conducted

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in compliance with the Australian National Health and Medical Research Council guidelines.14 All participants provided informed written consent.

Participants A convenience sample of 20 stroke survivors aged 18 years old or above, who were within 1 year of their most recent stroke and able to follow basic commands, were recruited via clinician referral. Clinicians were blinded to group allocation. Key exclusion criteria were inability to attend the center for testing, pregnancy, and being determined as medically unfit to participate by a medical practitioner. Absolute and relative contraindications to fitness testing15 were provided on the medical clearance form used in the study. Data were collected in the Human Performance Laboratory at the University of Newcastle, Australia. Due to time limitations for access to the Human Performance Laboratory, a block design was required. Hence, by necessity, this was a controlled but not randomized trial; the first 10 participants recruited were assigned to the intervention group with the next 10 assigned to the control group.

Assessments Assessments were undertaken in sessions conducted over 1 or 2 days, depending on each participant’s preference. Participant demographics (age, sex, country of birth, resides in a metropolitan, regional or rural location) and characteristics (stroke type, time since last stroke, number of strokes, side affected, thrombolysis with tPA, body mass index, current modified Rankin Scale score,16 and Functional Ambulation Category17) were recorded. Assessors (authors D.M. and A.D.) were not blinded to group allocation. Standardized instructions were provided to participants for each test. Feasibility was assessed by retention (number returning for 12-week assessments) and participation in the exercise program (intervention group, self-report) or other physical activities (both groups, self-report). At baseline, all participants were interviewed using a semistructured approach by author D.M. about their usual physical activity frequency, duration, and type, and about sedentary behavior. At the 12-week follow-up appointment, the participants were interviewed on their activity levels and the types of activities undertaken over the preceding 12 weeks. For the intervention group participants, the interview included their use of the prescribed program activities. Also, during their weekly phone calls or e-mails, the participants in the intervention group were asked about the activities they had been undertaking in the preceding week. Assessments of adherence to the exercise program and changes in physical activity levels were based on these self-reports.

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Safety was assessed by the occurrence of any adverse events during assessments (documented) or the intervention period (self-report). Adverse events included falls and cardiac, respiratory, or new neurological abnormalities; recurrent events; hospitalization; and musculoskeletal pain that did not settle within an hour of stopping exercise. Cardiorespiratory fitness was assessed using 3 tests. Standardized instructions were provided to the participants for each test. 1) The Six-Minute Walk Test (6MWT) was performed in accordance with the American Thoracic Society standards,18 with the exception of a 20-m straight walkway used due to limited space. Standardized instructions and encouragement were provided according to the guidelines and no physical assistance or support was provided.19 Distance walked was recorded. 2) The Shuttle Walk Test (SWT) required participants to walk between markers spaced 9 m apart (shuttles).20 Speeds were dictated by an audio CD (Glenfield Hospital NHS Trust, Leicester, UK) and increased each minute. The test was terminated when the participant was unable to reach within .5 m of the marker at the time of the audio signal. Standardized instructions for the test were used, including providing no encouragement during the test. If the participants were less than .5 m away from the cone when the beep sounded, feedback was provided that they were not going fast enough and needed to try to walk faster. The total number of shuttles walked was recorded. 3) The Cycle Progressive Exercise Test (cPXT) was performed on an upright cycle (818E Monark, Sweden). Participants cycled for 2-3 minutes for familiarization and to identify their preferred cadence (50 or 60 revolutions per minute) for the test. After a brief rest (2-3 minutes), the participant started pedaling and the test commenced once they reached their predetermined cadence. The workload resistance was adjusted each minute. The test commenced at a power output of 0 W with stepped increases in power output of 25 W each minute. Feedback was provided regarding participants’ maintenance of cadence. The final power output and duration of the test were recorded. During each of these tests, cardiorespiratory fitness was measured by VO2peak. The respiratory exchange ratio (R value) was used as an index of participant effort. Oxygen consumption and R values were recorded throughout each test using a portable metabolic system (K4b2; Cosmed, Rome, Italy). Heart rate (HR) was recorded via a 12-lead wireless electrocardiogram (ECG) device (Quark T12, Cosmed), which was monitored throughout each test by author A.D., who is experienced in conducting exercise tests. Conservative criteria were adopted to stop a test when any rhythm that was not normal appeared. A copy of the ECG was sent to

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author N.S. (Senior Staff Specialist Neurologist) for review regarding safety of further testing, participation in exercise, or need for cardiologist review. Data were transmitted wirelessly to a laptop and exported as comma-separated values (CSV) files. Test end criteria were the participant’s own volition; any concern with cardiac rhythm or the participant’s well-being; inability to reach .5 m of the marker before the beep sounded during the SWT; and inability during the cPXT to maintain cadence; reaching 85% heart rate reserve (HRR) during the cPXT, calculated using the Karvonen formula of 85% HRR = {[(220 − age) − resting HR] × .85} + resting HR.21 As HR is not usually monitored during the 6MWT or SWT in clinical settings, it was not used to set end criteria for these tests. Blood pressure was measured before and after each fitness test as a safety precaution. Reasons for stopping were recorded. Other assessments included the following: The 10-m Walk Test was used to assess fast and selfselected walking speeds.22 The time taken to walk the middle 10 m of a 14-m walkway was recorded. Three trials were performed for each speed. The average of the three trials was calculated then converted to velocity (in meter per second). The Step Test was used to assess dynamic standing balance using the protocol outlined by Hill et al.23 It involved stepping 1 foot on, then off, a 7.5-cm step as quickly as possible in a 15-second period. Both legs were tested. The Fatigue Assessment Scale (FAS),24 Patient Health Questionnaire (PHQ-9),25 and the Stroke and Aphasia Quality of Life-39 (SAQoL-39)26 questionnaire were used to assess fatigue, depression, and health-related quality of life, respectively. Higher scores represented worse levels of fatigue and depression, whereas lower scores indicated worse healthrelated quality of life. The primary measure used to assess change in cardiorespiratory fitness was absolute VO2peak (in liter per minute) as relative VO2peak (in milliliter per kilogram per minute) is affected by any change in weight over time. Changes in VO2peak during the 6MWT, SWT, and cPXT were all examined to determine whether sensitivity to change differed among these tests. Changes in other cardiorespiratory fitness measures (relative VO2peak, R value, and HR during the 6MWT, cPXT, and SWT), performance measures (6MWT distance [in meter], cPXT maximum workload [in watt] and duration [in seconds], number of shuttles completed during the SWT, fast and self-selected walking speed [in meter per second], and number of steps during step test), and fatigue, depression, and health-related quality of life scores were examined.

Intervention Following their baseline assessments, all participants continued to receive usual care. In addition, the intervention group received a 12-week individually tailored

home- and community-based exercise program. Programs were devised through consultation between the participant and 2 experienced clinicians: a neurological physiotherapist (author D.M.) and exercise scientist (author A.D.), who were independent of the usual-care therapists. Carers who were present at the session were included in the discussion and planning. The intervention was designed so that it could be applied in most settings: metropolitan, regional, or rural. The intervention aimed to increase daily physical activity and reduce sedentary time, using a whole-day approach to being more active.27 The health benefits of regular ongoing physical activity, including undertaking activity at a level that has the potential to improve cardiorespiratory fitness, were discussed. The potential benefits for preventing subsequent stroke were highlighted. Strategies to overcome any perceived barriers to being active were also considered. The individually tailored programs were based on participant preferences for activities, including any prestroke activity the participants wished to resume or work toward resuming, their physical capacity to undertake specific activities, and access to resources in their home and community, including pools, gyms, exercise classes, and therapy programs. An exercise manual was provided that included written information to reinforce the verbal information provided on exercising safely and overcoming barriers. The exercise manual contained a core home-exercise program, based on previously reported programs.28-35 This consisted of taskspecific exercises that participants could use as part of their intervention (see Appendix 1), and information on how to progress these exercises over time. The participants were strongly encouraged to exercise at a level with the potential to improve cardiorespiratory fitness by meeting the exercise recommendations of accruing at least 30 min/day of moderate intensity physical activity on most days of the week.6,36 They were encouraged to undertake activities using large muscle groups. The concepts of interval training and accruing activity in 10- to 15minute bouts were included in the discussion. Progressing the duration of the higher-intensity intervals and reducing the duration of the low-intensity intervals were discussed. Low-intensity intervals were encouraged to be active rather than complete rest. Following the development of the individually tailored program, each participant practiced his or her chosen activities using interval training on a circuit of 5-minute task-specific and ergometer workstations under supervision. This single bout of supervised exercise was designed to build confidence and to provide participants with the experience of applying interval training to the various activities practiced. This single bout of exercise program was conducted at the Human Performance Laboratory at the University of Newcastle. Ongoing contact during the 12 weeks was provided by 1 researcher (author A.D.) via weekly e-mail or telephone

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calls. The support was tailored to each participant’s specific requirements, which included some or all of the following: checking adherence to regular activity, providing encouragement and strategies to overcome barriers, and any additional advice required as to how to progress their exercise program. The content of the support was developed in consultation with authors A.D., D.M., and R.C. (Professor of Clinical Exercise Physiology). If any medical issues were raised during the support sessions, A.D. discussed with author N.S. (Senior Staff Specialist Neurologist) for advice and possible referral back to the treating doctor if appropriate. After the initial consultation, no further faceto-face contact was provided with the exception of any participant with concerns about attending communitybased facilities for the first time after stroke. These people were offered the option of having one of the research team accompany them to their initial exercise session. Usual care consisted of any required medical or therapy appointments. Two people in each group were enrolled in outpatient physiotherapy at the time they commenced the 12-week period. All others had been discharged from ongoing therapy. Control participants were asked to continue their routine activities during the 12 weeks. These participants were not provided with any information from the research team about increasing physical activity, did not undertake the interval-training practice session, and the only contact initiated by the research team was a phone call to confirm their booking for the 12week assessment session. The medical clearance form completed by each participant’s medical practitioner outlined that the stroke survivor would be undergoing fitness testing and a 12-week exercise program, but did not specify when the program would start.

Statistical Methods Baseline characteristics are summarized as means and standard deviations for continuous data, and numbers and percentages for categorical data. Differences between groups in baseline characteristics were tested using a t-test for continuous data and Fisher’s exact test for categorical data. The efficacy of the intervention was tested using analysis of covariance by fitting a linear regression model to the data with the outcome in the model being the outcome of interest at 12 weeks and the only predictor variable being their group (intervention or control). We included all of the data that were available for the analysis. The coefficient of the group variable is a measure of the treatment effect and can be interpreted as the difference between the groups at follow-up adjusted for baseline. Changes in means for each outcome were determined for each group. Between-group differences were determined by absolute difference and the difference in percent change from baseline between the 2 groups. For any missing data for items in the FAS, PHQ-9, or SAQoL, substitution was based

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on the mean of the other scores. As this was a pilot study, scatter plots illustrating data distribution and changes were used in addition to summary statistics.37 Analyses were conducted in SAS 9.4 (SAS Institute Inc., Cary, NC) and Stata V13 (StataCorp LP, College Station, TX).

Results Demographic and other characteristic data for the intervention and control groups at baseline were compared and are summarized in Table 1. There were no statistically significant differences between the groups. All participants had suffered an ischemic stroke and all were independently ambulant. Three intervention participants used a walking stick for the 6MWT at baseline; no participant required a walking aid for the follow-up 6MWT assessment. Reasons for each participant stopping the cPXT are outlined in Appendix 2.

Feasibility and Safety The target of 20 participants was reached and all participants attended the assessments at 12 weeks. No serious adverse events were observed during testing or reported by participants in either group or over the 12week period. During baseline data collection, 1 intervention group participant had intermittent right bundle branch block on ECG and was referred to his general practitioner for investigation. A researcher (author D.M.) accompanied 2 intervention group participants to their first visit to a community exercise program and participated in the exercise session with them. Based on interview self-reports, the intervention participants reported being physically active more than the control group participants over the 12-week period. All of the intervention group participants reported that they undertook their individualized exercise program. Seven of the 10 (70%) participants reported being active for at least 30 minutes on most days of the week; one reported being active for 20 minutes or more on most days of the week. The other 2 participants reported that they were more active than before they commenced the program, including breaking up long periods of sitting. Participants undertook a variety of community and homebased activities: walking (n = 7), running (n = 2), boot camp (n = 1), aqua-aerobics (n = 2), ergometers (n = 2), weights (n = 1), aerobics class (n = 1); and the individualized homeexercise program in their manual (n = 5). Two participants continued with outpatient physiotherapy 1-2 times per week. One person commenced Masterstroke, which is a 9-week secondary prevention group program run by health professionals that included 1 hour of exercise in each twicea-week session.38 Three people returned to leisure activities they participated in before their stroke including lawn bowls, horse riding, and dancing. These activities contributed to the accumulated physical activity levels of each participant across the 12 weeks and highlight the

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achievement of these particular participants’ objectives regarding physical activity. Of the control group participants, one self-reported increasing community-based activities including walking; one self-reported increasing, by a small amount, his or her home duties and walking; and five self-reported that they maintained their current levels of activity with only one of these reporting being active most days of the week. Three participants self-reported they had been less active, mainly due to health issues not related to their stroke. Three people received physiotherapy at some stage during the 12 weeks: two attended outpatient therapy and one was admitted for 2 weeks to a rehabilitation unit for inpatient therapy. Appendix 2 shows the data for individual participants for the 6MWT and cPXT. There were some missing data from the exercise tests. Reasons for missing data were 2 intervention and 2 control group participants were unable to undertake the cPXT due to pre-existing arthritic limitations (knee n = 3, hip n = 1); 1 control group participant was excluded from the 12-week cPXT because his resting HR was at 85% HRR, and 1 control group participant did not perform the SWT due to a mobility safety issue, poor balance when turning, which was identified during the 6MWT. Baseline cardiorespiratory fitness data for 1 participant were excluded due to equipment problems resulting in physiologically impossible values. HR data were missing for 3 intervention group participants during the 6MWT due to data from the ECG unit not being recorded on the laptop.

Intervention Efficacy There was a .18 L/min (95% confidence interval [CI]: .01-.36) greater improvement in VO2peak on the 6MWT in intervention participants than in controls (Table 2). There were trends to improvement in the SWT (.14 L/min [95% CI: −.04 to .32]) and cPXT (.20 L/min [95% CI: −.04 to .43]). Enhancing the plausibility of the 6MWT result, a very strong concordance emerged between the effect size estimate for VO2peak and performance measures for each of the 3 fitness tests. All 3 tests indicated 11%-15% greater benefit in the intervention group compared to the control group (Table 2). Figure 1 shows the changes for individual participants for selected cardiorespiratory fitness and performance measures and for the questionnaires. The intervention group improved 1.5 and 1.3 steps more (P < .05) than the control group for the right and left legs, respectively, in the step test. There were no statistically significant differences between the groups for changes in fatigue, depression, or health-related quality of life (Table 2).

Discussion Our 12-week program of home- and communitybased exercise was feasible for participants to undertake and was effective in improving cardiorespiratory fitness. The improvements were of a similar magnitude to those identified in meta-analyses of exercise to improve cardiorespiratory fitness after stroke.1,9 There were no serious

Table 1. Participant demographics and characteristics Characteristic Sex Age (years) Body mass index (kg/m2) Location of home

Country of birth Time since stroke (months) Number of strokes

Modified Rankin Scale

Side affected by stroke

Thrombolysis with tPA Functional Ambulation Category

Category or mean (SD)

Intervention (n = 10)

Control (n = 10)

P value

Male Mean (SD) Mean (SD) Metropolitan Regional Rural Australia Other Mean (SD) One Two Three 0 1 2 3 Left Right Neither Yes Mean (SD)

3 (30%) 54.4 (22.2) 27.5 (8.2) 6 (60%) 1 (10%) 3 (30%) 9 (90%) 1 (10%) 5.6 (5.3) 9 (90%) 1 (10%)

5 (50%) 62.0 (16.8) 28.5 (3.7) 5 (50%) 3 (30%) 2 (20%) 9 (90%) 1 (10%) 3.8 (1.2) 8 (80%) 1 (10%) 1 (10%) 1 (10%) 7 (70%) 2 (20%)

.65 .42 .72 .70

Abbreviations: SD, standard deviation; tPA, tissue plasminogen activator.

8 (80%) 1 (10%) 1 (10%) 4 (40%) 4 (40%) 2 (20%) 2 (20%) 4.9 (.3)

3 (30%) 3 (30%) 4 (40%) 2 (20%) 4.9 (.3)

1.00 .33 1.00

1.00

.73

1.00 1.00

Intervention Test and outcome measure

Baseline

12 weeks

Change

.18 (.20) 2.6 (2.6) 4 (21)‡ .02 (.16) 66.5 (63.8) .14 (.21) 1.8 (3.0) 2 (22) −.10 (.20) 6.9 (7.5)

Baseline

12 weeks

1.24 (.23) 1.24 (.27) 15.2 (2.6) 15.2 (3.2) 118 (21) 122 (25) .99 (.13) 1.09 (.14) 456.4 (100.9) 470.9 (105.7)

Between-group difference Change −.00 (.13)* .1 (1.8)* 5 (12) .10 (.18) 14.5 (38.5)

Absolute difference (95% CI) P value % Difference

.18 (.01-.36) 2.6 (.3-4.9) 3 (−14 to 20) .08 (−.03 to .19) 45.2 (.3-90.2)

.044 .030 .731 .137 .049

15.6 15.6 .1 −8.1 12.4

1.28 (.36) 16.2 (5.0) 134 (24) .91 (.10) 36.8 (17.0)

1.29 (.33) 16.3 (4.8) 134 (30) .96 (.11) 39.8 (17.9)

.00 (.11)† .1 (1.3)† 0 (11)* .05 (.13)* 3.0 (5.3)*

.14 (−.04 to .32) 1.8 (−.7 to 4.2) 1 (−19 to 20) .04 (−.05 to .14) 3.9 (−2.7 to 10.5)

.117 .142 .919 .336 .228

11.3 10.0 1.2 −15.3 10.9

.10 (.22)† 1.31 (.17) 1.6 (3.1)† 16.6 (4.0) −2 (24)† 136 (21) −.06 (.29)† 1.04 (.12) 15.0 (62.1)† 334.3 (58.6) 9.4 (29.7)† 121.4 (26.7)

1.21 (.19) 15.4 (4.2) 131 (20) 1.06 (.11) 317.1 (84.6) 117.9 (34.5)

−.10 (.12)§ −1.1 (1.4)§ −5 (10)‡ .03 (.15)‡ −17.1 (29.3)‡ −3.6 (17.3)‡

.20 (−.04 to .43) 2.9 (−.2 to 6.0) 0 (−20 to 20) .00 (−.19 to .19) 32.6 (−27.4 to 92.6) 10.2 (−20.8 to 41.2)

.091 .067 .992 .997 .259 .486

15.6 15.9 2.3 −8.3 10.1 12.4

.036 .041

13.3 11.2

.871 .437

6.3 .8

2.5 (2.1) 1.9 (1.6)

16.4 (3.9) 16.3 (3.9)

17.0 (3.5) 16.6 (3.4)

.6 (1.4) .3 (1.4)

1.5 (.1-2.9) 1.3 (.1-2.5)

.0 (.3) .1 (.1)

1.5 (.3) 1.2 (.2)

1.6 (.3) 1.3 (.2)

.1 (.1) .1 (.1)

−4.5 (4.9)

22.5 (7.9)

21.5 (6.7)

−1.0 (7.1)

1.3 (−3.37 to 5.95)

.567

−12.7

−2.4 (4.1)

5.4 (4.6)

4.7 (4.2)

−.7 (3.2)

.4 (−2.4 to 3.2)

.761

−16.7

−.1 (.5)

4.3 (.6)

4.4 (.5)

.1 (.3)

.2 (−.1 to .5)

.160

−2.9

.0 (−.1 to .2) .0 (−.1 to .1)

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Abbreviations: 6MWT, Six-Minute Walk Test; CI, confidence interval; cPXT, Cycle Progressive Exercise Test; PHQ-9, Patient Health Questionnaire; SAQoL-39, Stroke and Aphasia Quality of Life-39; SD, standard deviation; SWT, Shuttle Walk Test; VO2peak, peak oxygen consumption. For change scores: the number of participants included in the analysis = 10 except where *n = 9. †n = 8. ‡n = 7. §n = 6.

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6MWT 1.17 (.29) 1.35 (.33) VO2peak absolute (L/min) VO2peak relative (mL/kg/min) 16.0 (3.7) 18.6 (4.4) Heart rate (beats/min) 109 (18) 113 (12) R value .99 (.13) 1.01 (.09) Distance (m) 427.0 (123.0) 493.5 (89.6) SWT VO2peak absolute (L/min) 1.22 (.30) 1.36 (.40) VO2peak relative (mL/kg/min) 16.9 (4.8) 18.7 (5.0) Heart rate (beats/min) 114 (16) 116 (19) R value 1.02 (.17) .92 (.07) Shuttles (count) 36.3 (17.0) 43.2 (17.7) cPXT VO2peak absolute (L/min) 1.26 (.36) 1.35 (.42) VO2peak relative (mL/kg/min) 17.3 (5.0) 18.9 (5.0) Heart rate (beats/min) 127 (25) 125 (24) R value 1.11 (.17) 1.05 (.20) Duration (s) 303.8 (76.0) 318.8 (86.3) Workload (W) 100.0 (29.9) 109.4 (35.2) Step test (15 s) Steps right 14.7 (5.1) 17.2 (3.9) Steps left 14.6 (5.4) 16.5 (4.6) 10-min walk test Fast (m/s) 1.7 (.5) 1.7 (.3) Self-selected speed (m/s) 1.2 (.3) 1.3 (.2) Fatigue Assessment Scale Score (possible range 10 to 50) 26.2 (5.6) 21.8 (3.8) PHQ-9 Score (total out of 27) 8.1 (5.7) 5.7 (3.4) SAQoL Mean score (total out of 5) 4.1 (.5) 4.1 (.4)

Control

HOME EXERCISE TO IMPROVE POSTSTROKE FITNESS

Table 2. Outcome measures: within and between group scores (means [SD]) and differences. Group scores are means (SD)

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B. 6MWT: Distance (metres) [higher values better]

A. 6MWT: VO2peak absolute (L/min) [higher values better] Intervention

Intervention

Control

Control

2.0 600

500

1.5

400 1.0 300

200

0.5

C.

0 12W 0 12W SWT: Shuttles Completed (Number) [higher values better] Intervention

0

12W 0

D. cPXT: Workload (Watts) [higher values better] Intervention

Control

80

200

60

150

12W

Control

40 100

20 50 0 12W 0 E. 10m Walk Test: Fast (m/s) [higher values better] Intervention

12W

0

12W 0

Intervention

Control

2.5

40

2

30

1.5

20

1

12W

F. Fatigue Assessment Scale: Score (/50) [lower scores better] Control

10

0 12W 0 G. PHQ−9: Score (/27) [lower scores better] Intervention

12W

0

12W 0

H. SAQoL: Mean Score (/5) [higher scores better] Intervention

Control

12W

Control

5 15 4.5 10 4 5 3.5

0

3 0

12W 0

12W

0

12W 0

12W

Figure 1. Changes for individual participants for selected cardiorespiratory fitness and performance and questionnaire measures. Abbreviations: 6MWT, Six-Minute Walk Test; cPXT, Cycle Progressive Exercise Test; PHQ-9, Patient Health Questionnaire; SAQoL-39, Stroke and Aphasia Quality of Life-39; SWT, Shuttle Walk Test.

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adverse events and no withdrawals. The intervention design enabled stroke survivors from regional and rural, as well as metropolitan communities, to participate. Our results highlight that many of the barriers perceived by clinicians to incorporating aerobic training into neurorehabilitation, including concerns for patient safety, patients’ inability to participate, and lack of resources,39 can be overcome. It should be noted, however, that participants were self-selected, and all were independently ambulant. Our intervention appears a feasible method for incorporating cardiorespiratory fitness training into poststroke management. All intervention group participants selfreported increasing their levels of physical activity and reducing sedentary time, with the majority also meeting exercise recommendations for the frequency and duration of exercise.6,36 Our intervention did not require regular travel or attendance at a specific venue, which can be a barrier to participation.40 Importantly, there was no requirement for regular therapist supervision, which most would regard as a major cost saving, yet short periodic ongoing professional support41 was provided by phone or e-mail. The improvement in VO2peak we observed is comparable to that previously achieved in more resourceintensive programs.1 These programs typically used a single modality, such as a treadmill or cycle ergometer, for training,1 which may limit who can participate and the appeal of the program. Also, these programs required participants to attend a center at least once a week to undertake the intervention or for clinicians to undertake home visits several times per week.1 Resources for providing treatment once people are discharged back to the community after stroke are often very limited. Our results indicate that an intervention that requires minimal face-to-face contact may be sufficient for improving the cardiorespiratory fitness levels of independently ambulant stroke survivors. An important feature of the exercise program may have been the single session of supervised interval training performed over a circuit of different activities following baseline testing. Most participants reported that they were more confident to exercise after undertaking this session. The participants reported feeling reassured that they could exercise safely for a reasonable period of time (all performed for at least 10 minutes) and intensity using activities that they had identified they were interested in. The session gave the participants an experience of interval training and how to vary the intensity, and how to incorporate a variety of activities into their home-exercise program. To identify the key components that contribute to the success of this complex physical activity intervention, future studies should measure each component including the acceptability and perceived benefits. The VO2peak results observed during baseline testing are consistent with the low levels of fitness of people after stroke.1,2 The mean value for VO2peak of our participants at baseline fell in the 15- to 18-mL/kg/min range that has been suggested

42

as being a minimum requirement for independent living. The mean was well below published values for healthy people aged 60-69 years (men 33 ± 7.3 and women 27 ± 4.7 mLO2/kg/min).43 Improving the cardiorespiratory fitness of stroke survivors has the potential to enhance their ability to undertake activities of daily living. With improved fitness, the percentage of VO2peak required to undertake a task is reduced. This can increase submaximal exercise tolerance and endurance.6 Our intervention requires minimal clinician input, yet appears to be an effective approach to improve cardiorespiratory fitness and thus to contribute to poststroke recovery. The improvement in 6MWT distance highlights the potential of our intervention to significantly improve walking capacity in stroke survivors. The intervention group increased the distance walked during the 6MWT by 66 m to 493 m at 12 weeks. An improvement of more than 50 m is considered clinically significant.44 Walking endurance and speed are key components of community ambulation.45 The ability to “get out and about” in the community is considered very important by stroke survivors,46 and can reduce isolation and dependence while increasing social participation and physical activity.47 The change we observed was similar to those reported in meta-analyses investigating the impact on walking distance of gaitorientated training (41 m),48 cardiorespiratory fitness training involving walking (47 m),9 and mixed training involving walking (31 m).9 However, this change was only half of that seen with more intensive cardiovascular conditioning (111 m).10 In our study, 7 of 10 (70%) participants in the intervention group used walking as an activity compared to 2 of 10 (20%) participants in the control group. The use of walking as an exercise activity is a likely driver of the increased walking distance observed in the intervention group and has clear potential benefits for community participation. This raises the possibility that the improvements in 6MWT are reflective of improved walking ability, rather than a true indication of improved cardiorespiratory fitness. While the mean magnitude of change in absolute VO2peak was slightly higher for the cPXT than the 6MWT, there were fewer participants for the cPXT. This loss of statistical power is the likely explanation for the lack of significant difference for cPXT, rather than a physiological difference between the cPXT and the 6MWT. The improvements we saw in walking distance but not in self-selected walking speed are consistent with the metaanalysis of Mehta et al,10 who examined cardiovascular conditioning after stroke. At baseline, our cohort would already be considered community ambulators, with a selfselected walking speed greater than .8 m/s.49 Walking speed was similar to healthy people aged 60-69 years (men 1.3 m/s, women 1.2 m/s).50,51 Interestingly, participants were able to maintain their fast walking speed, measured over 10 m, to complete a 1-minute stage during the SWT. The ability to sustain speed is important for community activities such as safely crossing the road.52

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When examining the individual patient data, it is clear that many of the control group participants’ fitness appeared to deteriorate (Fig 1). Eighty percent of participants in the intervention group improved their 6MWT VO2peak, whereas 78% of the control group participants had a lower VO2peak during the 6MWT after 12 weeks (Fig 1, A). Participants who performed the worst in the intervention group at baseline for 6MWT distance, fast walking speed, fatigue, depression, and health-related quality of life appeared to make the greatest improvements (Fig 1, B, E-G). This finding suggests that such a program may particularly benefit those with the most to gain.

Strengths and Limitations A major strength of the present study was the individually tailored, home- and community-based program that enabled stroke survivors to participate, regardless of where they lived. Forty-four percent of participants lived in regional or rural communities. People from these communities are often unable to participate in clinical studies and programs that require them to travel to centerbased interventions in metropolitan settings. The point estimates for VO2 (peak and change) were very similar across the 3 fitness tests we used. The lack of statistically significant difference for the SWT and cPXT may be due to the inadequate power of the study or greater variability between participants. The R values achieved at the end of each test showed no group-by-time interaction between the intervention and control groups, suggesting that there were no differences in effort or intensity attained.32 There were some limitations with our fitness tests. The R values achieved during our tests indicate they were submaximal.53,54 Peak values for the cPXT may be underestimated for the participants who were stopped from continuing the exercise test when they reached 85% of age-predicted HRR. The use of a 20-m walkway during the 6MWT could have affected the VO2peak values achieved. Participants may have had to slow down more often to make the larger number of turns that were required compared to testing on a 30-m walkway. Although fitness tests may not always elicit a stroke survivor’s actual VO2peak,

the use of a standardized testing procedure allows for repetition over time to measure for change. The study was limited by the small number of selfselected participants and was not a randomized controlled trial. For the present pilot study, there was no blinding of assessors to group allocation. However, standardized tests and instructions were used. We relied on self-report to assess the exercise dose received throughout the 12 weeks and the changes in activity during the program. The accuracy of this information is limited by the participants’ recall and their ability to quantify their physical activity levels. Future studies would benefit from direct measures of activity via activity monitors and interviews conducted by blinded assessors using standardized interview schedules. The challenge of measuring exercise dose accurately in the real world has been recognized, as has the potential for emerging, low-cost wearable technology in measuring activity over time at home.12 The use of this technology would need to be considered for a larger trial.

Conclusion The results of the present pilot study show that a homeand community-based program to increase physical activity and reduce sedentary time is feasible and that it can result in improved cardiorespiratory fitness. Improving physical activity and cardiorespiratory fitness levels can provide multiple health benefits to stroke survivors. The present study demonstrates a promising intervention to improve the physical activity levels of communitydwelling stroke survivors and warrants further investigation in a large multicenter, randomized trial using wearable technology to examine dose–response relationships. Acknowledgments: We would like to thank our participants for volunteering their time and the carers who accompanied them to the sessions; the Hunter New England Local Health District staff, who assisted with recruitment; David Paul, who set up the electronic data entry forms; Amelia Tomkins and Lucy Murtha, who assisted with formatting the figures; and the research assistants, who assisted with data collection and entry.

Appendix 1. Summary of Activities Included in the Home-Exercise Manual Activity Sit to stand Fast/self-selected paced walking Balance

Equipment Chair with or without arm rests Track (e.g., hallway, length of driveway, between telegraph poles) Line on floor

Description

Progressions

Sit to stand, aiming to increase speed reduce upper limb Self-selected pace

↑ speed, number of repetitions ↓ use of arm rests, seat height ↑ walking or jogging speed

Standing feet together, standing on 1 leg, eyes open eyes closed, walking along line (normal step length or heel–toe)

Side stepping ± squats, side stepping crossing feet, backwards walking (continued on next page)

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Appendix 1. Activity

Equipment

(continued)

Description

Progressions

Step

Block between 5 and 25 cm high

Up and over forwards Up and over sideways Stepping up forward and down backwards Use table/bench for balance if required

Squat

Chair or bench

Side stepping around a table

Table or bench

High knee walking

Track (e.g., hallway)

Leg side raises

Chair or bench

Perform squat Start with small range of movement Use bench or chair for balance if required Sidestep around the table- to both left and right sides Hold onto table/bench for balance if required March on the spot March up and down a walkway Start with a small range of movement Hold onto table/bench for balance if required Hip abduction—left and right Hold onto chair/bench for balance if required

↓ use of table/bench ↑ speed Add in arm activities Start at a lower height and gradually build up ↑ depth of squat Hold arms out in front ↑ speed and number of repetitions Take wider steps Add in a squat ↑ speed and number of repetitions Bring knees up higher Add in simultaneous arm activities ↑ speed and number of repetitions ↑ range of motion Add weight around ankle ↑ speed and number of repetitions

Legend: ↑, increase; ↓, decrease.

Appendix 2. Data for Individual Participants for the 6MWT and cPXT (Absolute VO2peak and Performance Measures) Six-Minute Walk Test Absolute VO2peak (L/min)

Cycle Progressive Exercise Test

Distance walked (m)

Absolute VO2peak (L/min)

12 12 Participant Baseline weeks Change Baseline weeks Change Baseline Intervention group 1 1.074 2 .804 3 1.309 4 .972

1.390 1.045 1.387 1.322

.316 .241 .078 .350

294 202 406 455

415 347 494 559

121 145 88 104

12 weeks

Unable to do test Unable to do test 1.458 1.148 .876 1.086

Workload (W)

Change Baseline

Reasons for stopping

12 weeks

Change

Baseline

Leg fatigue Leg fatigue, SOB Knee pain Leg fatigue, SOB Interference on ECG, SOB SOB ECG abnorm →RBBB^ Leg fatigue, SOB

Leg fatigue SOB

HRR Knee pain

Leg fatigue Leg and general fatigue

Leg fatigue Leg fatigue HRR

Leg fatigue Leg fatigue HRR

−.310 .210

125 75

100 75

−25 0

5 6

1.313 .981

1.768 .998

.456 .016

598 330

641 413

43 83

1.659 .976

1.777 .984

.118 .008

150 100

150 100

0 0

7

1.763

1.817

.054

428

553

125

1.665

1.878

.214

100

150

50

8 9

1.418 1.156

1.392 1.590

−.026 .433

524 552

507 567

−17 15

1.332 1.379

1.308 1.835

−.024 .456

100 100

75 150

−25 50

10

.891

.788

−.104

481

439

−42

.698

.802

.103

50

75

25

Control group 1 1.002 2 1.278 3 1.445

.967 1.208 1.299

−.034 −.070 −.146

338 489 360

301 491 381

−37 2 21

Unable to do test 1.267 1.068 1.475 1.185

−.019 −.290

100 100

100 100

0 0

1.112 1.006 1.371 1.229

.192 −.045 −.014 –

433 600 520 593

423 619 481 609

−10 19 −39 16

Unable to do test 1.375 1.315 1.264 1.229 Equip 1.446

−.060 −.035 –

125 125 175

125 100 175

0 −25 0

4 5 6 7

.919 1.051 1.385 Equip

12 weeks

Leg fatigue Leg fatigue, SOB Leg fatigue, SOB Leg fatigue HRR

SOB

(continued on next page)

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Appendix 2.

(continued)

Six-Minute Walk Test Absolute VO2peak (L/min)

Cycle Progressive Exercise Test

Distance walked (m)

Absolute VO2peak (L/min)

12 12 Participant Baseline weeks Change Baseline weeks Change Baseline

12 weeks

Workload (W)

Change Baseline

8

1.388

1.303

−.085

449

480

31

.485

9

1.605

1.858

.253

477

561

84

1.467

Unable to do test 1.501

10

1.096

1.021

−.075

305

363

58

1.009

.958

–

75

12 weeks

.034

125

Unable to do test 150

−.052

100

75

Reasons for stopping

Change

Baseline

–

Leg fatigue

25

Leg fatigue

−25

Leg fatigue

12 weeks Unable to do test Leg fatigue, SOB Leg fatigue

Abbreviations: abnorm, abnormality; ECG, electrocardiogram; Equip, no data due to equipment issues; HRR, reaching 85% heart rate reserve; →RBBB^, subsequently diagnosed with right bundle branch block; SOB, shortness of breath.

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13 40. Nicholson S, Sniehotta FF, van Wijck F, et al. A systematic review of perceived barriers and motivators to physical activity after stroke. Int J Stroke 2013;8:357-364. 41. Simpson LA, Eng JJ, Tawashy AE. Exercise perceptions among people with stroke: barriers and facilitators to participation. Int J Ther Rehabil 2011;18:522-530. 42. Shephard RJ. Maximal oxygen intake and independence in old age. Br J Sports Med 2009;43:342-346. 43. Fletcher GF, Balady GJ, Amsterdam EA, et al. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation 2001;104:1694-1740. 44. Holland AE, Hill CJ, Rasekaba T, et al. Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil 2010;91:221-225. 45. Barclay R, Ripat J, Mayo N. Factors describing community ambulation after stroke: a mixed-methods study. Clin Rehabil 2015;29:509-521. 46. Lord SE, McPherson K, McNaughton HK, et al. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil 2004;85:234-239. 47. McCluskey A, Ada L, Middleton S, et al. Improving quality of life by increasing outings after stroke: study protocol for the out-and-about trial. Int J Stroke 2013;8:5458. 48. van de Port IGL, Wood-Dauphinee S, Lindeman E, et al. Effects of exercise training programs on walking competency after stroke: a systematic review. Am J Phys Med Rehabil 2007;86:935-951. 49. Bowden MG, Balasubramanian CK, Behrman AL, et al. Validation of a speed-based classification system using quantitative measures of walking performance poststroke. Neurorehabil Neural Repair 2008;22:672-675. 50. Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy 2011;97:182-189. 51. Salbach NM, O’Brien KK, Brooks D, et al. Reference values for standardized tests of walking speed and distance: a systematic review. Gait Posture 2015;41:341-360. 52. Andrews AW, Chinworth SA, Bourassa M, et al. Update on distance and velocity requirements for community ambulation. J Geriatr Phys Ther 2010;33:128-134. 53. Ivey F, Macko R, Ryan A, et al. Cardiovascular health and fitness after stroke. Top Stroke Rehabil 2005;12:1-16. 54. Balady GJ, Arena R, Sietsema K, et al. Clinician’s Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation 2010;122:191-225.