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Aerobic Exercise in Early Subacute Stroke

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ClinicalTrials.gov Identifier: NCT02107768
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Klas Sandberg, Ostergotland County Council, Sweden

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Other: Aerobic exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
Study Start Date : January 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

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Arms and Interventions
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Arm Intervention/treatment
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
 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.
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. Aerobic capacity [ Time Frame: Baseline,3month ]
    cardiorespiratory stress test (Watt)


Secondary Outcome Measures :
  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 Outcome Measures:
  1. EQ5-D [ Time Frame: Baseline,3month,6month ]
    Quality of life

  2. Stroke Impact Scale [ Time Frame: Baseline,3month,6month ]
    Recovery after stroke, participation


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107768


Sponsors and Collaborators
Klas Sandberg
Investigators
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Principal Investigator: Klas Sandberg, Msc,RPT Rehab East, Local Health Care Östergötland County Council
Principal Investigator: Marie Kleist, Bsc,RPT Rehab East, Local Health Care Östergötland County Council
Principal Investigator: Lars Falk, PhD,MD Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
Principal Investigator: Paul Enthoven, PhD,RPT Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Klas Sandberg, MSc,RPT, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT02107768    
Other Study ID Numbers: 2010/396-31
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Klas Sandberg, Ostergotland County Council, Sweden:
Stroke
Exercise
Randomized trial
Quality of Life
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases