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Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aerobic exercise training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age >20 years, male sex, and onset of injury more than one year

Exclusion Criteria:

  • known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Spinal cord injury

    Arm Description

    Cardio-pulmonary exercise testing and aerobic exercise training

    Outcomes

    Primary Outcome Measures

    serum myokines

    Secondary Outcome Measures

    Full Information

    First Posted
    July 1, 2016
    Last Updated
    July 27, 2016
    Sponsor
    National Taiwan University Hospital
    Collaborators
    National Science Council, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02850133
    Brief Title
    Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury
    Official Title
    Effect of Aerobic Exercise Training on the Blood Biochemical Factors and Peripheral Hemodynamics in Person With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI. Method: Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.
    Detailed Description
    The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal cord injury
    Arm Type
    Experimental
    Arm Description
    Cardio-pulmonary exercise testing and aerobic exercise training
    Intervention Type
    Other
    Intervention Name(s)
    aerobic exercise training
    Intervention Description
    aerobic exercise training for 36 sessions within 12-16 weeks
    Primary Outcome Measure Information:
    Title
    serum myokines
    Time Frame
    12-16 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age >20 years, male sex, and onset of injury more than one year Exclusion Criteria: known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The study is registered in publicly accessible site.

    Learn more about this trial

    Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury

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