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Randomized Controlled Trial
. 2009 Jul 22:339:b2810.
doi: 10.1136/bmj.b2810.

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

Gudrun Boysen  1 , Lars-Henrik Krarup, Xianrong Zeng, Adam Oskedra, Janika Kõrv, Grethe Andersen, Christian Gluud, Anders Pedersen, Marianne Lindahl, Lotte Hansen, Per Winkel, Thomas Truelsen; ExStroke Pilot Trial Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Gudrun Boysen et al. BMJ. .

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 >or=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.

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Conflict of interest statement

Competing interests: None declared.

Figures

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Fig 1 Participant flow chart of ExStroke Pilot Trial. Withdrawn denotes patients withdrawn due to severe recurrent stroke.
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Fig 2 Participants’ median (interquartile range) scores on the physical activity scale for the elderly (PASE) at each follow-up visit. Data are shown for the intention to treat analysis (top) and the per protocol analysis for participants who attended all planned visits (bottom)
See this image and copyright information in PMC

References

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