ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: A multinational randomised controlled clinical trial

Abstract

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 Clinical Trials NCT00132483.