Aerobic Exercise in Early Subacute Stroke

NCT02107768 | Completed

• 1 other identifier: 2010/396-31
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Keywords

Stroke; Exercise; Randomized trial; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Aerobic capacity

  cardiorespiratory stress test (Watt)

  Baseline,3month

Secondary Outcomes (2)

• Balance

  Baseline,3month

• Walking capacity

  Baseline,3month

Other Outcomes (2)

• EQ5-D

  Baseline,3month,6month

• Stroke Impact Scale

  Baseline,3month,6month

Study Arms (2)

Exercise recommendation

EXPERIMENTAL

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

Aerobic exercise

EXPERIMENTAL

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

Interventions

Aerobic exercise 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; Exercise recommendation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Klas Sandberg: lead

Related Publications (2)

• 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.

  PMID: 29338111 DERIVED

• 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.

  PMID: 26903147 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc,RPT

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 4, 2015

Record last verified: 2015-02