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High-intensity strength training in addition to standard non-surgical treatment in patients with knee osteoarthritis – a randomized controlled trial
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
Conclusions: Telomeres of the chondrocyte cultured for future implantation are larger enough to think that these cells are not senescent.
Figure 1. Q-FISH of the biopsies included in the study. Nuclei are stained in blue and telomeres in green.
Table 1 Doubling time and number of cell divisions during the cultures Cartilage biopsy
Age (years)
Gender
Time in culture (days)
Dubling time (days)
Estimated number of eel divisions
B1 B2 B3
40 36 42
Female Male Male
53 49 35
4.83 5.04 3.72
10.97 9.72 9.42
Table 2 Median and 20 th percentile of telomere length of the cartillage biopsies Cartilage biopsy
Median lenght (bp)
20 th Percentile lenght (bp)
Coeficient of variation
B1 B2 B3
10.270 10.733 10.467
6.840 7.095 7.059
3.94 5.72 3.54
Trial Design 731 OSTEOARTHRITIS PATIENT PREFERENCE FOR USING COMPUTERS, SMARTPHONES, AND INTERNET TO PARTICIPATE IN CLINICAL TRIALS L. Khurana y, E.M. Durand y, S.T. Gary y, A.V. Otero y, C. Hall y, M. Cala z, S. Egan z, S.M. Dallabrida y. y ERT, Boston, MA, USA; z Endpoint Outcomes, Boston, MA, USA Purpose: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate clinical trial endpoints. The aim of this study was to characterize how patients with osteoarthritis prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during trial design may reduce patient burden and improve patient engagement. Methods: 104 subjects with osteoarthritis were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials. Results: Subjects were diverse in age, sex, ethnicity, and technology use. 50% reported having a computer at home, 48% reported using the internet daily, and 43% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (25%), 2-6 months (18%), 1-2 years (13%), or 5þ years (16%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (22%), 2-6 months (15%), 1-2 years (17%), or 5þ years (14%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (29%), 8am-noon (18%), or 4pm8 pm (15%). Subjects thought it would be necessary (15%) or helpful (68%) to have an audible alarm to remind them to record their
S443
symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a paper form (60%), a smartphone provided by their physician (51%), or a web-based online form (49%). Conclusions: Subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments. 732 HIGH-INTENSITY STRENGTH TRAINING IN ADDITION TO STANDARD NON-SURGICAL TREATMENT IN PATIENTS WITH KNEE OSTEOARTHRITIS e A RANDOMIZED CONTROLLED TRIAL P.M. Holm, II y, z, P. Aagaard, II z, H. Schrøder, II x, S.T. Skou, II y, k. y Næstved- Slagelse- Ringsted Hosp., Region Zealand, Slagelse, Denmark; z Res. unit for Muscle Physiology and Biomechanics, Dept. of Sports Sci. and Clinical Biomechanics, Univ. of Southern Denmark, Odense M, Denmark; x Næstved- Slagelse- Ringsted Hosp., Region Zealand, Næstved, Denmark; k Res. unit for Musculoskeletal Function and Physiotherapy, Dept. of Sports Sci. and Clinical Biomechanics, Univ. of Southern Denmark, Odense M, Denmark Purpose: Substantial evidence supports the efficacy of exercise to improve pain, function and quality of life in patients with knee OA. However, there is still a paucity of evidence on which exercise protocol that is most effective. The purpose of this study is to investigate the potentially additive effects of progressive high-intensity knee extensor strength training in addition to 12 weeks of neuromuscular exercise and education. Methods: This is a parallel group randomized controlled trial (RCT) with short-term follow-ups at 6 weeks and 12 weeks and a longterm follow-up at 12 months. The primary endpoint is the change in the subscale Activities of Daily Living on the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL), from baseline to 12 weeks. Secondary endpoints include the other four KOOS subscales, EuroQol-5D (EQ-5D), maximum knee extensor muscle power and functional performance (40 m shuttle walk, 30 s chair rise & stair negotiation). With a low-frequent training regime (2 weekly sessions), 12 weeks of training (24 sessions) are required for strengthand hypertrophy adaptations to readily manifest into clinically worthwhile effects. The supplementary follow-up at week 6 will provide a measure of dose-response relationships between groups. The one-year follow-up will allow for assessments of the sustainability of eventual treatment effects between groups. 90 patients from the Zealand Region of Denmark with knee-OA found not eligible for a total knee replacement (TKR) by an orthopaedic surgeon, meeting the inclusion criteria and consenting to participate in the study, will be randomized to one of two parallel training groups using permuted block randomization. The exercise interventions will take place at the Hospitals of Slagelse and Næstved in the Zealand Region, Denmark. To ensure blinding between exercise groups, the intervention- (neuromuscular exercise & education þ strength training) and control (neuromuscular exercise & education) groups will be allocated to training on separate days. To ensure equal distribution of subjects between each Hospital, allocation is conducted in permuted blocks within each stratum. Randomization will be conducted via a computer. The allocated numbers will be put in sealed opaque envelopes administered by an external staff member. Allocation of subjects will only be disclosed after conclusion of baseline testing. This study will be conducted as a single-blind study, where all outcome assessors will be blinded to subject allocation. Blinding of patients and physiotherapists delivering the intervention is not possible. Finally, the statistician performing the statistical analysis will be blinded and a blinded interpretation of the results will be conducted before breaking the randomization code. This study’s results will be reported in accordance with the CONSORT guidelines on non-pharmacological trials. To secure and demonstrate adherence to pre-specified outcome measures, this study protocol will be registered at “Clinicaltrials.gov”. Results: Results from this study will provide evidence to further improve the exercise protocol for patients with knee OA. There is sufficient evidence to suggest that exercise is an effective treatment to improve pain, function and quality of life in patients with knee
S444
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
OA. However, little is known of the exact dose and type of exercise for optimal effects. Reduced lower-limb muscle strength is a risk factor for development and progression of knee OA. Yet, evaluations of the beneficial effects of strengthening exercise in the knee OA population lack sufficient documentation and are generally poorly reported.
Conclusions: If proven feasible and efficient, strengthening exercise can be easily integrated into the current management of knee OA. As most clinical rehabilitation settings include standard machines for strengthening exercise or have access to training facilities with the equipment, the additional costs related to including strengthening exercise in the current exercise protocol can be kept to a minimum.
Conclusions: Telomeres of the chondrocyte cultured for future implantation are larger enough to think that these cells are not senescent.
Figure 1. Q-FISH of the biopsies included in the study. Nuclei are stained in blue and telomeres in green.
Table 1 Doubling time and number of cell divisions during the cultures Cartilage biopsy
Age (years)
Gender
Time in culture (days)
Dubling time (days)
Estimated number of eel divisions
B1 B2 B3
40 36 42
Female Male Male
53 49 35
4.83 5.04 3.72
10.97 9.72 9.42
Table 2 Median and 20 th percentile of telomere length of the cartillage biopsies Cartilage biopsy
Median lenght (bp)
20 th Percentile lenght (bp)
Coeficient of variation
B1 B2 B3
10.270 10.733 10.467
6.840 7.095 7.059
3.94 5.72 3.54
Trial Design 731 OSTEOARTHRITIS PATIENT PREFERENCE FOR USING COMPUTERS, SMARTPHONES, AND INTERNET TO PARTICIPATE IN CLINICAL TRIALS L. Khurana y, E.M. Durand y, S.T. Gary y, A.V. Otero y, C. Hall y, M. Cala z, S. Egan z, S.M. Dallabrida y. y ERT, Boston, MA, USA; z Endpoint Outcomes, Boston, MA, USA Purpose: Patient engagement and adherence are critical to the success of clinical trials. Electronic patient-reported outcomes (ePROs) are increasingly used to evaluate clinical trial endpoints. The aim of this study was to characterize how patients with osteoarthritis prefer to use various types of technology to report ePROs in a clinical trial. Considering patient preference during trial design may reduce patient burden and improve patient engagement. Methods: 104 subjects with osteoarthritis were surveyed regarding their preferences for using computers, smartphones, and internet in clinical trials. Results: Subjects were diverse in age, sex, ethnicity, and technology use. 50% reported having a computer at home, 48% reported using the internet daily, and 43% reported owning a smartphone. Subjects reported that they would be willing to participate in a clinical trial using the internet for up to 1 month (25%), 2-6 months (18%), 1-2 years (13%), or 5þ years (16%). Similarly, subjects were willing to participate in a clinical trial using a smartphone for up to 1 month (22%), 2-6 months (15%), 1-2 years (17%), or 5þ years (14%). When asked what time of day they would prefer to complete a daily electronic diary, subjects preferred 8pm-midnight (29%), 8am-noon (18%), or 4pm8 pm (15%). Subjects thought it would be necessary (15%) or helpful (68%) to have an audible alarm to remind them to record their
S443
symptoms. In a multi-select question, subjects preferred to report their symptoms once a day for a clinical trial using a paper form (60%), a smartphone provided by their physician (51%), or a web-based online form (49%). Conclusions: Subjects are willing to use computers, smartphones, and internet in a clinical trial setting. Trial sponsors should consider patient preferences for specific technology features to reduce patient burden and improve engagement and adherence when using ePRO assessments. 732 HIGH-INTENSITY STRENGTH TRAINING IN ADDITION TO STANDARD NON-SURGICAL TREATMENT IN PATIENTS WITH KNEE OSTEOARTHRITIS e A RANDOMIZED CONTROLLED TRIAL P.M. Holm, II y, z, P. Aagaard, II z, H. Schrøder, II x, S.T. Skou, II y, k. y Næstved- Slagelse- Ringsted Hosp., Region Zealand, Slagelse, Denmark; z Res. unit for Muscle Physiology and Biomechanics, Dept. of Sports Sci. and Clinical Biomechanics, Univ. of Southern Denmark, Odense M, Denmark; x Næstved- Slagelse- Ringsted Hosp., Region Zealand, Næstved, Denmark; k Res. unit for Musculoskeletal Function and Physiotherapy, Dept. of Sports Sci. and Clinical Biomechanics, Univ. of Southern Denmark, Odense M, Denmark Purpose: Substantial evidence supports the efficacy of exercise to improve pain, function and quality of life in patients with knee OA. However, there is still a paucity of evidence on which exercise protocol that is most effective. The purpose of this study is to investigate the potentially additive effects of progressive high-intensity knee extensor strength training in addition to 12 weeks of neuromuscular exercise and education. Methods: This is a parallel group randomized controlled trial (RCT) with short-term follow-ups at 6 weeks and 12 weeks and a longterm follow-up at 12 months. The primary endpoint is the change in the subscale Activities of Daily Living on the Knee injury and Osteoarthritis Outcome Score (KOOS-ADL), from baseline to 12 weeks. Secondary endpoints include the other four KOOS subscales, EuroQol-5D (EQ-5D), maximum knee extensor muscle power and functional performance (40 m shuttle walk, 30 s chair rise & stair negotiation). With a low-frequent training regime (2 weekly sessions), 12 weeks of training (24 sessions) are required for strengthand hypertrophy adaptations to readily manifest into clinically worthwhile effects. The supplementary follow-up at week 6 will provide a measure of dose-response relationships between groups. The one-year follow-up will allow for assessments of the sustainability of eventual treatment effects between groups. 90 patients from the Zealand Region of Denmark with knee-OA found not eligible for a total knee replacement (TKR) by an orthopaedic surgeon, meeting the inclusion criteria and consenting to participate in the study, will be randomized to one of two parallel training groups using permuted block randomization. The exercise interventions will take place at the Hospitals of Slagelse and Næstved in the Zealand Region, Denmark. To ensure blinding between exercise groups, the intervention- (neuromuscular exercise & education þ strength training) and control (neuromuscular exercise & education) groups will be allocated to training on separate days. To ensure equal distribution of subjects between each Hospital, allocation is conducted in permuted blocks within each stratum. Randomization will be conducted via a computer. The allocated numbers will be put in sealed opaque envelopes administered by an external staff member. Allocation of subjects will only be disclosed after conclusion of baseline testing. This study will be conducted as a single-blind study, where all outcome assessors will be blinded to subject allocation. Blinding of patients and physiotherapists delivering the intervention is not possible. Finally, the statistician performing the statistical analysis will be blinded and a blinded interpretation of the results will be conducted before breaking the randomization code. This study’s results will be reported in accordance with the CONSORT guidelines on non-pharmacological trials. To secure and demonstrate adherence to pre-specified outcome measures, this study protocol will be registered at “Clinicaltrials.gov”. Results: Results from this study will provide evidence to further improve the exercise protocol for patients with knee OA. There is sufficient evidence to suggest that exercise is an effective treatment to improve pain, function and quality of life in patients with knee
S444
Abstracts / Osteoarthritis and Cartilage 25 (2017) S76eS444
OA. However, little is known of the exact dose and type of exercise for optimal effects. Reduced lower-limb muscle strength is a risk factor for development and progression of knee OA. Yet, evaluations of the beneficial effects of strengthening exercise in the knee OA population lack sufficient documentation and are generally poorly reported.
Conclusions: If proven feasible and efficient, strengthening exercise can be easily integrated into the current management of knee OA. As most clinical rehabilitation settings include standard machines for strengthening exercise or have access to training facilities with the equipment, the additional costs related to including strengthening exercise in the current exercise protocol can be kept to a minimum.