ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trialBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b2810 (Published 22 July 2009) Cite this as: BMJ 2009;339:b2810
- Gudrun Boysen, professor of neurology1,
- Lars-Henrik Krarup, PhD student16,
- Xianrong Zeng, neurologist2,
- Adam Oskedra, neurologist3,
- Janika Kõrv, neurologist4,
- Grethe Andersen, neurologist5,
- Christian Gluud, head of Copenhagen Trial Unit6,
- Anders Pedersen, study nurse1,
- Marianne Lindahl, physiotherapist1,
- Lotte Hansen, physiotherapist1,
- Per Winkel, statistical adviser6,
- Thomas Truelsen, neurologist1
- for the ExStroke Pilot Trial Group
- 1Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen NV, Denmark
- 2Department of Neurology, Sichuan Provincial People’s Hospital, Chengdu, China
- 3Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland
- 4Department of Neurology and Neurosurgery, University of Tartu, Estonia
- 5Department of Neurology, Aarhus University Hospital, Denmark
- 6Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital
- Correspondence to: G Boysen
- Accepted 28 April 2009
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
Details of the ExStroke Pilot Trial Group. Steering committee—G Boysen, T Truelsen, C Gluud. Coordinating investigator and guarantor for the study—G Boysen. Investigators—G Andersen, Anders Christensen, Kim Holsted, L-H Krarup, J Kõrv, Sascha Michelsen, Signe Tellerup Nielsen, Tang Ning, A Oskedra, Mai Roose, Mette Søndergaard, Rikke Thomsen, Sun Xiangrong, Zeng X, Nina Åslund. Study nurse—A Pedersen. Physiotherapists—Anne Junker Alsted, Krista Ankru, L Hansen, M Lindahl, Monika Pietrzak. Randomisation coordinators and data management—Nader Salas, Rita Aslan, Bitten Hansen, Pia Hughes, Lars Klingenberg, C Gluud. Secretary—Inger Hedegaard. Adjudication committee—Jette Ingerslev, Helle Iversen, Marianne Schroll, Christian Kruse-Larsen, Jesper Sylvest, Bjarne Sigurd, Steen Husted. Independent data monitoring and safety committee—Jørgen Hilden, Troels Staehelin Jensen. Statistical analyses—P Winkel.
Funding: The ExStroke Pilot Trial was funded by the Ludvig and Sara Elsass’ Foundation, Hede Nielsen Foundation, Eva and Henry Frænkel’s Foundation, Søren and Helene Hempel’s Foundation, and King Christian X Foundation. The funding sources had no involvement in the design of the trial; data collection, management, analysis, interpretation, and reporting; writing of the paper; or submission of the article for publication.
Competing interests: None declared.
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