search
Back to results

Aerobic Exercise in Early Subacute Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Klas Sandberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Randomized trial, Quality of Life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Exercise recommendation

    Aerobic exercise

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Aerobic capacity
    cardiorespiratory stress test (Watt)

    Secondary Outcome Measures

    Balance
    Time Up and Go(TUG) ,Single Leg Stance(SLS)
    Walking capacity
    Six minute walk test (6MWT ), 10 meters Walking test

    Full Information

    First Posted
    April 3, 2014
    Last Updated
    February 3, 2015
    Sponsor
    Klas Sandberg
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02107768
    Brief Title
    Aerobic Exercise in Early Subacute Stroke
    Official Title
    Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Klas Sandberg

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Stroke, Exercise, Randomized trial, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise recommendation
    Arm Type
    Experimental
    Arm Description
    Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts
    Arm Title
    Aerobic exercise
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Aerobic exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Aerobic capacity
    Description
    cardiorespiratory stress test (Watt)
    Time Frame
    Baseline,3month
    Secondary Outcome Measure Information:
    Title
    Balance
    Description
    Time Up and Go(TUG) ,Single Leg Stance(SLS)
    Time Frame
    Baseline,3month
    Title
    Walking capacity
    Description
    Six minute walk test (6MWT ), 10 meters Walking test
    Time Frame
    Baseline,3month
    Other Pre-specified Outcome Measures:
    Title
    EQ5-D
    Description
    Quality of life
    Time Frame
    Baseline,3month,6month
    Title
    Stroke Impact Scale
    Description
    Recovery after stroke, participation
    Time Frame
    Baseline,3month,6month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Klas Sandberg, Msc,RPT
    Organizational Affiliation
    Rehab East, Local Health Care Östergötland County Council
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marie Kleist, Bsc,RPT
    Organizational Affiliation
    Rehab East, Local Health Care Östergötland County Council
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Lars Falk, PhD,MD
    Organizational Affiliation
    Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paul Enthoven, PhD,RPT
    Organizational Affiliation
    Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29338111
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26903147
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Aerobic Exercise in Early Subacute Stroke

    We'll reach out to this number within 24 hrs