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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Exercise, Bedcycling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

Usual care and bedcycling.

Usual care

Outcomes

Primary Outcome Measures

Change in Modified Rankin Scale (mRS)

Functional Outcome

Secondary Outcome Measures

Change in Barthel ADL-Index

ADL

Change in 6-Minutes Walking test (6MWT)

Walking Ability

Full Information

NCT ID

NCT04241952

First Posted

January 14, 2020

Last Updated

January 24, 2020

Sponsor

Klas Sandberg

1. Study Identification

Unique Protocol Identification Number

NCT04241952

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

December 15, 2015 (Actual)

Primary Completion Date

December 15, 2015 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Klas Sandberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Rehabilitation, Exercise, Bedcycling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

RCT

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise group

Arm Type

Experimental

Arm Description

Usual care and bedcycling.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Usual care

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Bedcycling

Primary Outcome Measure Information:

Title

Change in Modified Rankin Scale (mRS)

Description

Functional Outcome

Time Frame

Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.

Secondary Outcome Measure Information:

Title

Change in Barthel ADL-Index

Description

ADL

Time Frame

Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.

Title

Change in 6-Minutes Walking test (6MWT)

Description

Walking Ability

Time Frame

Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Enthoven, PhD

Organizational Affiliation

Linkopings University,Sweden

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

33704913

Citation

Sandberg K, Kleist M, Enthoven P, Wijkman M. Hemodynamic responses to In-Bed Cycle Exercise in the acute phase after moderate to severe stroke: A randomized controlled trial. J Clin Hypertens (Greenwich). 2021 May;23(5):1077-1084. doi: 10.1111/jch.14232. Epub 2021 Mar 11.

Results Reference

derived

Learn more about this trial

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

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