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

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Arms and Interventions

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.

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

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

Primary Outcome Measures :

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

Secondary Outcome 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

Other Outcome Measures:

EQ5-D [ Time Frame: Baseline,3month,6month ]
Quality of life
Stroke Impact Scale [ Time Frame: Baseline,3month,6month ]
Recovery after stroke, participation

Eligibility Criteria

Information from the National Library of Medicine

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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

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.


Responsible Party:	Klas Sandberg, MSc,RPT, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:	NCT02107768 History of Changes
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:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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