Effects of Early Exercise in Patients With Moderate to Severe Stroke.
1 other identifier
interventional
52
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Dec 2015
Longer than P75 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedJanuary 27, 2020
January 1, 2020
Same day
January 14, 2020
January 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Barthel ADL-Index
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)
Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.
Study Arms (2)
Exercise group
EXPERIMENTALUsual care and bedcycling.
Control group
NO INTERVENTIONUsual care
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klas Sandberglead
Related Publications (1)
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.
PMID: 33704913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Enthoven, PhD
Linkopings University,Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Investigator
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 27, 2020
Study Start
December 15, 2015
Primary Completion
December 15, 2015
Study Completion
December 30, 2019
Last Updated
January 27, 2020
Record last verified: 2020-01