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

NCT ID: NCT04241952

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise group

Usual care and bedcycling.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Bedcycling

Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Bedcycling

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klas Sandberg

OTHER

Sponsor Role lead

Responsible Party

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Klas Sandberg

Clinical Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul Enthoven, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkopings University,Sweden

References

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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.

Reference Type DERIVED
PMID: 33704913 (View on PubMed)

Other Identifiers

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Stroke2015

Identifier Type: -

Identifier Source: org_study_id

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