Aerobic Exercise in Early Subacute Stroke

NCT ID: NCT02107768

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise recommendation

Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: 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

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 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.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: 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

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klas Sandberg

OTHER

Sponsor Role: lead

Responsible Party

Klas Sandberg

MSc,RPT

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Klas Sandberg, Msc,RPT

Role: PRINCIPAL_INVESTIGATOR

Rehab East, Local Health Care Östergötland County Council

Marie Kleist, Bsc,RPT

Role: PRINCIPAL_INVESTIGATOR

Rehab East, Local Health Care Östergötland County Council

Lars Falk, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,

Paul Enthoven, PhD,RPT

Role: PRINCIPAL_INVESTIGATOR

Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University

References

Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.

Reference Type: DERIVED

PMID: 29338111 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26903147 (View on PubMed)

Other Identifiers

2010/396-31

Identifier Type: -

Identifier Source: org_study_id