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Home Bicycle Exercise and Aerobic Capacity

Primary Purpose

Metabolic Cardiovascular Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bicycle exercise
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Cardiovascular Syndrome focused on measuring Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult with metabolic syndrome or type 2 diabetes

Exclusion Criteria:

  • hyperglycemic crisis or HbA1c > 12%;
  • serum creatinine levels greater than 200 mmol/L;
  • acute or chronic infectious diseases;
  • limitations in the ability to undertake regular exercise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bicycle Exercise

    Arm Description

    Bicycle Exercise for 12 weeks

    Outcomes

    Primary Outcome Measures

    Metabolic syndrome
    Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria

    Secondary Outcome Measures

    Muscle strength
    A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
    Brain-derived neurotrophic factor
    Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
    Arterial stiffness
    Pulse wave velocity

    Full Information

    First Posted
    September 27, 2014
    Last Updated
    October 15, 2014
    Sponsor
    Taichung Veterans General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02268292
    Brief Title
    Home Bicycle Exercise and Aerobic Capacity
    Official Title
    The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taichung Veterans General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program. All participators underwent an indoor bicycle exercise for twelve weeks. In addition to demographic data and biochemical tests were determined after an overnight fasting. Extension of muscle strength was detected in the dominant lower extremity.
    Detailed Description
    This prospective open-labeled study was conducted in Taichung Veterans General Hospital. The adult participants with metabolic syndrome and/or type 2 diabetes were enrolled. MetS. The procedures were fully explained to all subjects before the cardiopulmonary exercise test. ll enrolled subjects received a scheduled twelve-week program for exercise-training program. A commercially available bicycle with an indoor bicycle trainer are used as the home exercise training modality. All medications were not allowed to be changed during the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Cardiovascular Syndrome
    Keywords
    Metabolic syndrome, Diabetes, Muscle strength, Aerobic exercise, Bicycle, Brain-derived neurotrophic factor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bicycle Exercise
    Arm Type
    Experimental
    Arm Description
    Bicycle Exercise for 12 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    bicycle exercise
    Intervention Description
    All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.
    Primary Outcome Measure Information:
    Title
    Metabolic syndrome
    Description
    Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Muscle strength
    Description
    A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
    Time Frame
    12 weeks
    Title
    Brain-derived neurotrophic factor
    Description
    Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
    Time Frame
    12 weeks
    Title
    Arterial stiffness
    Description
    Pulse wave velocity
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult with metabolic syndrome or type 2 diabetes Exclusion Criteria: hyperglycemic crisis or HbA1c > 12%; serum creatinine levels greater than 200 mmol/L; acute or chronic infectious diseases; limitations in the ability to undertake regular exercise

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25682570
    Citation
    Tsai SW, Chan YC, Liang F, Hsu CY, Lee IT. Brain-derived neurotrophic factor correlated with muscle strength in subjects undergoing stationary bicycle exercise training. J Diabetes Complications. 2015 Apr;29(3):367-71. doi: 10.1016/j.jdiacomp.2015.01.014. Epub 2015 Feb 7.
    Results Reference
    derived

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    Home Bicycle Exercise and Aerobic Capacity

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