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

A Systematic Review and Meta-Analysis on Self-Management for Improving Risk Factor Control in Stroke Patients

“…Three studies reported on recurrent stroke or TIA events [36, 41,44]. Although in all three studies there were no differences between the groups, recurrent event rate was not the primary objective of the studies, nor were they powered for this variable.…”

“…The number of techniques used in each of the 14 interventions ranged between two and six (median of three techniques). The duration and number of sessions ranged between 2 weeks [37] and 24 months [44], and 2 [37, 40] to 13 [42] sessions, respectively. The mean length of each individual session ranged between 38.5 and 73 minutes.…”

“…Although several studies each reported on more than one stroke risk factor, nine interventions had a focus on self-management for lifestyle behaviours in general [31-35, 38-40, 43], two interventions had a specific focus on self-management for physical activity [42][43][44], two interventions had a focus on blood pressure [36,41], and one on medication adherence [37].…”

“…In seven studies, the interventions were administered in-person [32, 34, 36-37, 40, 43-44], six on an individual basis [34, 36-37, [43][44][45], one using a group format [32], and one using both individual and group formats [40]. Three studies delivered the intervention via telehealth, using a telephone [33,38] [41][42]).…”

“…Thus, future research should include follow-up data collection and report on the longer-term retention of the effect of self-management interventions. Next, two studies [33,44] required conversion of the data from medians and interquartile ranges to means and standard deviations, and several studies required conversion of ORs to SMDs to estimate the effect sizes. Conversion of data and effect sizes has the potential to increase error, especially in studies with small sample sizes, due to the use of mathematical formulas that only provide conversion estimates.…”