Effects of Progressive Elastic Band Resistance Training

Prader-Willi Syndrome Clinical Trial

Official title:

Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565081
• Other study ID #: 04-XD33-100
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2018
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperphagia
• Prader-Willi Syndrome
• Resistance Training
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the handgrip strength functional physical assessment	hand grip strength (pounds),	Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Primary	Changes in the 30 second chair stand functional physical assessment	30-second chair stand test (times)	Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Primary	Changes in the timed up and go functional physical assessment	timed up-and-go test (seconds)	Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Primary	Changes in the two minute step up functional physical assessment	2 minute step up test (times)	Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Primary	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)	Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Primary	Change in the BMI body composition	Body weight (km) and height (m) will be combined to report as BMI (kg/m2)	Change from Baseline body composition components at 6 months
Primary	Change in the percentage of body fat of body composition	Regional percentage body fat (%)	Change from Baseline body composition components at 6 months
Primary	Change in the body fat mass of body composition	Fat mass (kg)	Change from Baseline body composition components at 6 months
Primary	Change in the lean body mass of body composition	Lean body mass (kg)	Change from Baseline body composition components at 6 months