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

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
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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. |
- Aerobic capacity [ Time Frame: Baseline,3month ]cardiorespiratory stress test (Watt)
- 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
- EQ5-D [ Time Frame: Baseline,3month,6month ]Quality of life
- Stroke Impact Scale [ Time Frame: Baseline,3month,6month ]Recovery after stroke, participation

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

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
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 |
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 |
Stroke Exercise Randomized trial Quality of Life |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |