ExStroke
ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial
Year of Publication: 2009
Authors: Gudrun Boysen, Lars-Henrik Krarup, Xianrong Zeng, ..., Thomas Truelsen
Journal: BMJ
Citation: BMJ 2009;339:b2810
PDF: Clinical Question
Does repeated verbal encouragement and instruction in being physically active result in sustained increase in stroke patients' physical activity as measured by the Physical Activity Scale for the Elderly (PASE)?
Bottom Line
Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score in stroke patients
Major Points
- Multicentre, multinational randomized trial with 314 patients with mild ischaemic stroke
- Intervention consisted of repeated verbal instructions about physical activity over 24 months
- Primary outcome was difference in PASE scores between groups
- No significant difference in PASE scores: 69.1 vs 64.0 (difference 5.0, P=0.36)
- No significant effects on mortality, recurrent stroke, myocardial infarction, or falls
- More intensive strategies needed to promote physical activity after stroke
Design
Study Type: Randomized controlled trial
Randomization: 1
Blinding: Masked outcome assessment - interviewers masked to randomization obtained PASE scores and clinical events, adjudicated by blinded adjudication committee
Enrollment Period: August 2003 to October 2005
Follow-up Duration: 24 months
Centers: 8
Countries: Denmark, China, Poland, Estonia
Sample Size: 314
Analysis: Intention-to-treat and per-protocol analysis using mixed model analysis (proc mixed SAS 9.1) with square root transformation of PASE scale, Cox analyses for clinical events
Inclusion Criteria
- Patients with ischaemic stroke aged ≥40 years
- Able to walk unassisted (canes and walkers allowed)
- Enrolled within 90 days of onset of stroke symptoms
- Verbal and written informed consent obtained
Exclusion Criteria
- Inability to understand the meaning of the trial
- Unwillingness to participate
- Medical contraindications to exercise
- Modified Rankin scale of 4 or 5 before the qualifying event
Baseline Characteristics
| Characteristic | Control | Active |
|---|---|---|
| Median age (years) | 69.4 (59.6-75.8) | 69.7 (60.0-77.7) |
| Women | 69 (43.6%) | 68 (43.3%) |
| Median Scandinavian stroke scale | 54 (51-57) | 54 (51-58) |
| Median PASE score before stroke | 65 (50-106) | 76 (50-124) |
| Mean BMI | 25.9 (4.5) | 25.8 (4.2) |
| Mean systolic BP (mm Hg) | 150.2 (29.2) | 152.7 (21.1) |
| Prior stroke | 27 (17.2%) | 22 (14.0%) |
| Diabetes | 17 (10.8%) | 28 (17.8%) |
| Hypertension | 78 (49.7%) | 93 (59.2%) |
| Current smoking | 66 (42.0%) | 49 (31.2%) |
Arms
| Field | Intervention Group | Control |
|---|---|---|
| Intervention | Repeated encouragement and verbal instruction on being physically active given by physiotherapist. Instruction in detailed training programme before discharge and at five follow-up visits during 24 months. Programme individualized according to patient's resources, former activities, and preferences. Telephone calls between visits | Standard treatment without detailed information on physical activity. Follow-up visits with same frequency as intervention group but without instructions in physical activity |
| Duration | 24 months | 24 months |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Difference in Physical Activity Scale for the Elderly (PASE) score between intervention and control groups | Primary | 64.0 | 69.1 | 0.36 | |
| Recurrent stroke | Secondary | 11 (7.0%) | 14 (8.9%) | 1.30 (0.59 to 2.87) | 0.51 |
| Myocardial infarction | Secondary | 2 (1.3%) | 2 (1.3%) | 1.01 (0.14 to 7.17) | 0.99 |
| Death (all cause) | Secondary | 9 (5.7%) | 11 (7.0%) | 1.41 (0.57 to 3.50) | 0.46 |
| Vascular death | Secondary | 4 (2.5%) | 3 (1.5%) | 0.76 (0.17 to 3.41) | 0.72 |
| Fall fracture | Adverse | 12 (7.6%) | 5 (3.2%) | 0.46 (0.16 to 1.31) | 0.14 |
| First falls | Adverse | 54 (34%) | 53 (34%) | 1.08 (0.73 to 1.58) | 0.70 |
Subgroup Analysis
No significant effect of centre and no significant interactions between protocol specified variables and the intervention indicator
Criticisms
- Only about 15% of stroke patients were recruited, with 15% declining due to reluctance to engage in physical training
- Physiotherapists and investigators were unaware of PASE scores during the trial
- Repeated questioning about physical activity in control group may have increased their PASE scores
- Trial not powered to show effects on recurrent stroke, MI, or survival
- Possible selection bias as some patients declined participation due to lack of interest in physical training
- Most participants had mild strokes limiting generalizability to more severe stroke patients
Funding
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
Based on: ExStroke (BMJ, 2009)
Authors: Gudrun Boysen, Lars-Henrik Krarup, Xianrong Zeng, ..., Thomas Truelsen
Citation: BMJ 2009;339:b2810
Content summarized and formatted by NeuroTrials.ai.