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Community-based exercise programs incorporating healthcare-community partnerships to improve function post-stroke: feasibility of a 2-group randomized controlled trial |
Aravind G, Bashir K, Cameron JI, Howe JA, Jaglal SB, Bayley MT, Teasell RW, Moineddin R, Zee J, Wodchis WP, Tee A, Hunter S, Salbach NM |
Pilot and Feasibility Studies 2022 Apr 22;8(88):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Despite the potential for community-based exercise programs supported through healthcare-community partnerships (CBEP-HCPs) to improve function post-stroke, insufficient trial evidence limits widespread program implementation and funding. We evaluated the feasibility and acceptability of a CBEP-HCP compared to a waitlist control group to improve everyday function among people post-stroke. METHODS: We conducted a 3-site, pilot randomized trial with blinded follow-up evaluations at 3, 6, and 10 months. Community-dwelling adults able to walk 10 m were stratified by site and gait speed and randomized (1:1) to a CBEP-HCP or waitlist control group. The CBEP-HCP involved a 1-hour, group exercise class, with repetitive and progressive practice of functional balance and mobility tasks, twice a week for 12 weeks. We offered the exercise program to the waitlist group at 10 months. We interviewed 13 participants and 9 caregivers post-intervention and triangulated quantitative and qualitative results. Study outcomes included feasibility of recruitment, interventions, retention, and data collection, and potential effect on everyday function. RESULTS: Thirty-three people with stroke were randomized to the intervention (n = 16) or waitlist group (n = 17). We recruited 1 to 2 participants/month at each site. Participants preferred being recruited by a familiar healthcare professional. Participants described a 10- or 12-month wait in the control group as too long. The exercise program was implemented per protocol across sites. Five participants (31%) in the intervention group attended fewer than 50% of classes for health reasons. In the intervention and waitlist group, retention was 88% and 82%, respectively, and attendance at 10-month evaluations was 63% and 71%, respectively. Participants described inclement weather, availability of transportation, and long commutes as barriers to attending exercise classes and evaluations. Among participants in the CBEP-HCP who attended >= 50% of classes, quantitative and qualitative results suggested an immediate effect of the intervention on balance, balance self-efficacy, lower limb strength, everyday function, and overall health. CONCLUSION: The CBEP-HCP appears feasible and potentially beneficial. Findings will inform protocol revisions to optimize recruitment, and program and evaluation attendance in a future trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03122626. Registered April 21, 2017 -- retrospectively registered.
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