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A community-based exercise and education scheme for stroke survivors: a randomized controlled trial and economic evaluation [with consumer summary]
Harrington R, Taylor G, Hollinghurst S, Reed M, Kay H, Wood VA
Clinical Rehabilitation 2010 Jan;24(1):3-15
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; 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: The evaluation of a community-based exercise and education scheme for stroke survivors. DESIGN: A single blind parallel group randomized controlled trial. SETTING: Leisure and community centres in the south-west of England. SUBJECTS: Stroke survivors (median (IQR) time post stroke 10.3 (5.4 to 17.1) months). 243 participants were randomized to standard care (124) or the intervention (119). INTERVENTION: Exercise and education schemes held twice weekly for eight weeks, facilitated by volunteers and qualified exercise instructors (supported by a physiotherapist), each with nine participants plus carers or family members. METHOD: Participants were assessed by a blinded independent assessor at two weeks before the start of the scheme, nine weeks and six months. One-year follow-up was by postal assessment. MAIN MEASURES: Primary outcomes: Subjective Index of Physical and Social Outcome (SIPSO); Frenchay Activities Index; Rivermead Mobility Index. NHS, social care and personal costs. Secondary outcomes included WHOQoL-Bref. ANALYSIS: Intention-to-treat basis, using non-parametric analysis to investigate change from baseline. Economic costs were compared in a cost-consequences analysis. RESULTS: There were significant between-group changes in SIPSO physical at nine weeks (median (95% confidence interval (CI)), 1 (0 to 2): p = 0.022) and at one year (0 (-1 to 2): p = 0.024). (WHOQol-Bref psychological (6.2 (-0.1 to 9.1): p = 0.011) at six months. Mean cost per patient was higher in the intervention group. The difference, excluding inpatient care, was Great British Pounds 296 (95% CI -321 to 913). CONCLUSION: The community scheme for stroke survivors was a low-cost intervention successful in improving physical integration, maintained at one year, when compared with standard care.

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