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

January 24, 2020 updated by: Klas Sandberg

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual care
Experimental: Exercise group
Usual care and bedcycling.
Other: Exercise
Bedcycling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Barthel ADL-Index
Time Frame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
ADL
Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Change in 6-Minutes Walking test (6MWT)
Time Frame: Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Walking Ability
Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klas Sandberg

Investigators

  • Principal Investigator: Paul Enthoven, PhD, Linkopings University,Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

December 15, 2015

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stroke2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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