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Effects of Progressive Elastic Band Resistance Training

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ClinicalTrials.gov Identifier: NCT03565081
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Resistance Training Device: PWS elastic band training group Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PWS elastic band training group
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.
 Device: PWS elastic band training group
PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the handgrip strength functional physical assessment [ Time Frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks ]
    hand grip strength (pounds),

  2. Changes in the 30 second chair stand functional physical assessment [ Time Frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks ]
    30-second chair stand test (times)

  3. Changes in the timed up and go functional physical assessment [ Time Frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks ]
    timed up-and-go test (seconds)

  4. Changes in the two minute step up functional physical assessment [ Time Frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks ]
    2 minute step up test (times)

  5. Changes in the balance functional physical assessment [ Time Frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks ]
    Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)

  6. Change in the BMI body composition [ Time Frame: Change from Baseline body composition components at 6 months ]
    Body weight (km) and height (m) will be combined to report as BMI (kg/m2)

  7. Change in the percentage of body fat of body composition [ Time Frame: Change from Baseline body composition components at 6 months ]
    Regional percentage body fat (%)

  8. Change in the body fat mass of body composition [ Time Frame: Change from Baseline body composition components at 6 months ]
    Fat mass (kg)

  9. Change in the lean body mass of body composition [ Time Frame: Change from Baseline body composition components at 6 months ]
    Lean body mass (kg)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565081


Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
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Principal Investigator: Valeria JY Chiu, MD Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
More Information
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Publications of Results:

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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT03565081    
Other Study ID Numbers: 04-XD33-100
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
Prader-Willi Syndrome
Resistance Training
Body Composition
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders