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Clinical Trials/NCT04241952
NCT04241952CompletedNot Applicable

Effects of Early Exercise in Patients With Moderate to Severe Stroke - a Randomized Controlled Trial

Klas Sandberg0 sites52 target enrollmentStarted: December 15, 2015Last updated:
Conditions

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

Sponsor
Klas Sandberg
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Klas Sandberg

Clinical Investigator

Ostergotland County Council, Sweden

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