Aerobic Exercise in Early Subacute Stroke

Overview

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.

Full Title of Study: “Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Other: Aerobic exercise
    • 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 1. 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.

Arms, Groups and Cohorts

  • Experimental: Exercise recommendation
    • Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts
  • Experimental: 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: 1. 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.

Clinical Trial Outcome Measures

Primary Measures

  • Aerobic capacity
    • Time Frame: Baseline,3month
    • cardiorespiratory stress test (Watt)

Secondary Measures

  • Balance
    • Time Frame: Baseline,3month
    • Time Up and Go(TUG) ,Single Leg Stance(SLS)
  • Walking capacity
    • Time Frame: Baseline,3month
    • Six minute walk test (6MWT ), 10 meters Walking test

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Klas Sandberg
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Klas Sandberg, MSc,RPT – Ostergotland County Council, Sweden
  • Overall Official(s)
    • Klas Sandberg, Msc,RPT, Principal Investigator, Rehab East, Local Health Care Östergötland County Council
    • Marie Kleist, Bsc,RPT, Principal Investigator, Rehab East, Local Health Care Östergötland County Council
    • Lars Falk, PhD,MD, Principal Investigator, Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
    • Paul Enthoven, PhD,RPT, Principal Investigator, Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University

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