Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- Change in Modified Rankin Scale (mRS)
Study Overview
Brief Summary
Purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability.
Methods: Patients with medium to severe stroke (NHISS >7) were recruited 24 - 48 hours after stroke onset from two stroke units in Sweden. Both groups received usual care. The intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. Functional outcome was measured with modified Rankin Scale (mRS) and Barthel index and walking with the 6-minute walking test (6MWT). Measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years.
- •Diagnose stroke with The National Institutes of Health Stroke Scale (NIHSS) 7-42 points.
- •Ability to understand the Swedish language.
- •Approval of medical responsible physician to participate in the study.
Exclusion Criteria
- •Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.
Outcomes
Primary Outcomes
Change in Modified Rankin Scale (mRS)
Time Frame: Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Functional Outcome
Secondary Outcomes
- Change in 6-Minutes Walking test (6MWT)(Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.)
- Change in Barthel ADL-Index(Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.)
Investigators
Klas Sandberg
Clinical Investigator
Ostergotland County Council, Sweden