Aerobic Exercise in Early Subacute Stroke

Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Aerobic exercise

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity	cardiorespiratory stress test (Watt)	Baseline,3month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5-D	Quality of life	Baseline,3month,6month
Stroke Impact Scale	Recovery after stroke, participation	Baseline,3month,6month

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Stroke; Quality of Life; Randomized trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2010/396-31