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Clinical Trials/NCT04241952
NCT04241952
Completed
Not Applicable

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

Klas Sandberg0 sites52 target enrollmentDecember 15, 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Klas Sandberg
Enrollment
52
Primary Endpoint
Change in Modified Rankin Scale (mRS)
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2015
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Klas Sandberg
Responsible Party
Sponsor Investigator
Principal Investigator

Klas Sandberg

Clinical Investigator

Ostergotland County Council, Sweden

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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.)

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