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Completed

NCT Number: NCT02107768

Aerobic Exercise in Early Subacute Stroke

The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.

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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

50 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

  • Ability to understand Swedish language.
  • Ability to walk 5 meters with or without the support of any means or person.
  • Be able to get up on a cycle ergometer and cycle in their own chosen pace.
  • Approval of medically responsible physician to conduct physical training in groups.

Exclusion criteria

  • Medical or neurological diseases that may affect the exercise execution.
  • Patients for whom transportation to and from hospital can not be arranged during intervention period

Treatment and study plan

Aerobic Exercise

Other

Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) .

Two fitness goals was to be achieved during the training session

  • An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate.

2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate.

Primary outcomes

  1. Aerobic capacity

    Time frame: Baseline,3month

    cardiorespiratory stress test (Watt)

Secondary outcomes

  1. Balance

    Time frame: Baseline,3month

    Time Up and Go(TUG) ,Single Leg Stance(SLS)

  2. Walking capacity

    Time frame: Baseline,3month

    Six minute walk test (6MWT ), 10 meters Walking test

Other outcomes

  1. EQ5-D

    Time frame: Baseline,3month,6month

    Quality of life

  2. Stroke Impact Scale

    Time frame: Baseline,3month,6month

    Recovery after stroke, participation

Sponsors and collaborators

Lead sponsor

Klas Sandberg

Other

Registry information

Official study title

Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2014
Registry last updated
Feb 4, 2015

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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