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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04241952

Enrollment

Registered

2020-01-27

Start date

2015-12-15

Completion date

2019-12-30

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Rehabilitation, Exercise, Bedcycling

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.

Interventions

OTHERExercise

Bedcycling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

RCT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Modified Rankin Scale (mRS)	Baseline 24-48 hours after onset, postintervention 3 weeks after baseline and follow up 3-months after baseline.	Functional Outcome

Secondary

Measure	Time frame	Description
Change in Barthel ADL-Index	Baseline 24-48 hours after stroke onset, postintervention 3-weeks after baseline and follow up 3-months after baseline.	ADL
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.	Walking Ability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026