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OpenTrials
Completed

NCT Number: NCT04241952

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Bedcycling

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Klas Sandberg

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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