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
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
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
NCT ID
NCT03565081
First Posted
May 28, 2018
Last Updated
June 11, 2018
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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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