Effects of Progressive Elastic Band Resistance Training

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT03565081

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome Resistance Training	Device: PWS elastic band training group	N/A

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

Study Type:

Interventional

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 :

Feb 1, 2016

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

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.

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

Primary Outcome Measures

Changes in the handgrip strength functional physical assessment [Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks]
hand grip strength (pounds),
Changes in the 30 second chair stand functional physical assessment [Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks]
30-second chair stand test (times)
Changes in the timed up and go functional physical assessment [Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks]
timed up-and-go test (seconds)
Changes in the two minute step up functional physical assessment [Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks]
2 minute step up test (times)
Changes in the balance functional physical assessment [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)
Change in the BMI body composition [Change from Baseline body composition components at 6 months]
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 [Change from Baseline body composition components at 6 months]
Regional percentage body fat (%)
Change in the body fat mass of body composition [Change from Baseline body composition components at 6 months]
Fat mass (kg)
Change in the lean body mass of body composition [Change from Baseline body composition components at 6 months]
Lean body mass (kg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

Principal Investigator: Valeria JY Chiu, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

ClinicalTrials.gov Identifier:

NCT03565081

Other Study ID Numbers:

04-XD33-100

First Posted:

Jun 21, 2018

Last Update Posted:

Jun 21, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Prader-Willi Syndrome

Resistance Training

Body Composition

Additional relevant MeSH terms:

Prader-Willi Syndrome

Syndrome

Study Results

No Results Posted as of Jun 21, 2018