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A randomized trial of two home-based exercise programmes to improve functional walking post-stroke [with consumer summary]
Mayo NE, Mackay-Lyons MJ, Scott SC, Moriello C, Brophy J
Clinical Rehabilitation 2013 Jul;27(7):659-671
clinical trial
7/10 [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: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To estimate the relative effectiveness in improving walking ability and other mobility and health outcomes post-stroke of two home-based exercise programmes -- stationary cycling and an exercise and walking programme. DESIGN: An observer-blinded, randomized, pragmatic, trial with repeated measures. SETTING: Hospital centers in two Canadian cities. SUBJECTS: People within 12 months of acute stroke who were able to walk > 10 meters independently and healthy enough to engage in exercise. INTERVENTIONS: Two dose-equivalent interventions, one involving stationary cycling and the other disability-targeted interventions were tested. Both protocols required daily moderate intensity exercise at home building up to 30 minutes per day. One group exercised on a stationary bicycle, the second group carried out mobility exercises and brisk walking. MAIN MEASURES: The primary outcome was walking capacity as measured by the six-minute walk test (6MWT). Secondary outcomes were physical function, role participation, health-related quality of life exercise adherence, and adverse events. RESULTS: The study failed to meet recruitment targets: 87 participants (cycle group, n = 43; exercise group, n = 44) participated. No significant effects of group or time were revealed for the 6MWT, which was approximately 320 m at randomization. A significant effect for role participation was found in favor of the exercise group (global odds ratio (OR) for cycling versus exercise was 0.51; 95% confidence interval (CI) 0.27 to 0.95). Change in the 6MWT between highest and lowest adherence categories was statistically significant (p = 0.022). CONCLUSIONS: Both programmes were equally effective in maintaining walking capacity after discharge from stroke rehabilitation; or were equally ineffective in improving walking capacity. CLINICALTRIALS.GOV NUMBER: NCT00786045.

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