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Effects of Progressive Elastic Band Resistance Training

Primary Purpose

Prader-Willi Syndrome, Resistance Training

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PWS elastic band training group
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring Prader-Willi Syndrome, Resistance Training, Body Composition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PWS individuals who can cooperate with motor performances

Exclusion Criteria:

  • arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance
  • severe cognitive impairment or parents who cannot read nor write.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PWS elastic band training group

    Arm Description

    Genetically confirmed diagnosis of PWS participants were recruited. The PWS participants needed to have sufficient command of the Mandarin language to understand the study information and motivated to conduct the training program.

    Outcomes

    Primary Outcome Measures

    Changes in the handgrip strength functional physical assessment
    hand grip strength (pounds),
    Changes in the 30 second chair stand functional physical assessment
    30-second chair stand test (times)
    Changes in the timed up and go functional physical assessment
    timed up-and-go test (seconds)
    Changes in the two minute step up functional physical assessment
    2 minute step up test (times)
    Changes in the balance functional physical assessment
    Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)
    Change in the BMI body composition
    Body weight (km) and height (m) will be combined to report as BMI (kg/m2)
    Change in the percentage of body fat of body composition
    Regional percentage body fat (%)
    Change in the body fat mass of body composition
    Fat mass (kg)
    Change in the lean body mass of body composition
    Lean body mass (kg)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2018
    Last Updated
    June 11, 2018
    Sponsor
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03565081
    Brief Title
    Effects of Progressive Elastic Band Resistance Training
    Official Title
    Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. The aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with PWS.
    Detailed Description
    Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, BMI, and regional extremities fat mass and percentage. Regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. Balance function achieved significant improvements after 16 weeks of training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prader-Willi Syndrome, Resistance Training
    Keywords
    Prader-Willi Syndrome, Resistance Training, Body Composition

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PWS elastic band training group
    Arm Type
    Experimental
    Arm Description
    Genetically confirmed diagnosis of PWS participants were recruited. The PWS participants needed to have sufficient command of the Mandarin language to understand the study information and motivated to conduct the training program.
    Intervention Type
    Device
    Intervention Name(s)
    PWS elastic band training group
    Intervention Description
    PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.
    Primary Outcome Measure Information:
    Title
    Changes in the handgrip strength functional physical assessment
    Description
    hand grip strength (pounds),
    Time Frame
    Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
    Title
    Changes in the 30 second chair stand functional physical assessment
    Description
    30-second chair stand test (times)
    Time Frame
    Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
    Title
    Changes in the timed up and go functional physical assessment
    Description
    timed up-and-go test (seconds)
    Time Frame
    Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
    Title
    Changes in the two minute step up functional physical assessment
    Description
    2 minute step up test (times)
    Time Frame
    Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
    Title
    Changes in the balance functional physical assessment
    Description
    Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)
    Time Frame
    Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
    Title
    Change in the BMI body composition
    Description
    Body weight (km) and height (m) will be combined to report as BMI (kg/m2)
    Time Frame
    Change from Baseline body composition components at 6 months
    Title
    Change in the percentage of body fat of body composition
    Description
    Regional percentage body fat (%)
    Time Frame
    Change from Baseline body composition components at 6 months
    Title
    Change in the body fat mass of body composition
    Description
    Fat mass (kg)
    Time Frame
    Change from Baseline body composition components at 6 months
    Title
    Change in the lean body mass of body composition
    Description
    Lean body mass (kg)
    Time Frame
    Change from Baseline body composition components at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PWS individuals who can cooperate with motor performances Exclusion Criteria: arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance severe cognitive impairment or parents who cannot read nor write.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valeria JY Chiu, MD
    Organizational Affiliation
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    16509530
    Citation
    Schlumpf M, Eiholzer U, Gygax M, Schmid S, van der Sluis I, l'Allemand D. A daily comprehensive muscle training programme increases lean mass and spontaneous activity in children with Prader-Willi syndrome after 6 months. J Pediatr Endocrinol Metab. 2006 Jan;19(1):65-74. doi: 10.1515/jpem.2006.19.1.65.
    Results Reference
    result
    PubMed Identifier
    12520259
    Citation
    Eiholzer U, Nordmann Y, l'Allemand D, Schlumpf M, Schmid S, Kromeyer-Hauschild K. Improving body composition and physical activity in Prader-Willi Syndrome. J Pediatr. 2003 Jan;142(1):73-8. doi: 10.1067/mpd.2003.mpd0334.
    Results Reference
    result

    Learn more about this trial

    Effects of Progressive Elastic Band Resistance Training

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