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ExStroke pilot trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial [with consumer summary] |
Boysen G, Krarup LH, Zeng X, Oskedra A, Korv J, Andersen G, Gluud C, Pedersen A, Lindahl M, Hansen L, Winkel P, Truelsen T |
BMJ 2009 Aug 1;339:b2810 |
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* |
OBJECTIVES: To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity. DESIGN: Multicentre, multinational, randomised clinical trial with masked outcome assessment. SETTING: Stroke units in Denmark, China, Poland, and Estonia. PARTICIPANTS: 314 patients with ischaemic stroke aged >= 40 years who were able to walk -- 157 (mean age 69.7 years) randomised to the intervention, 157 (mean age 69.4 years) in the control group. INTERVENTIONS: Patients randomised to the intervention were instructed in a detailed training programme before discharge and at five follow-up visits during 24 months. Control patients had follow-up visits with the same frequency but without instructions in physical activity. MAIN OUTCOME MEASURES: Physical activity assessed with the Physical Activity Scale for the Elderly (PASE) at each visit. Secondary outcomes were clinical events. RESULTS: The estimated mean PASE scores were 69.1 in the intervention group and 64.0 in the control group (difference 5.0 (95% confidence interval -5.8 to 15.9), p = 0.36. The intervention had no significant effect on mortality, recurrent stroke, myocardial infarction, or falls and fractures. CONCLUSION: Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score. More intensive strategies seem to be needed to promote physical activity after ischaemic stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT00132483.
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