Effects of Early Exercise in Patients With Moderate to Severe Stroke.

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241952
• Other study ID #: Stroke2015
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 30, 2019
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Exercise
Bedcycling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Klas Sandberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Rankin Scale (mRS)	Functional Outcome	Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.
Secondary	Change in Barthel ADL-Index	ADL	Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Secondary	Change in 6-Minutes Walking test (6MWT)	Walking Ability	Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.