Clinical trial NCT03565081: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prader-Willi Syndrome
Resistance Training
Keywords: Prader-Willi Syndrome
Resistance Training
Body Composition
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the handgrip strength functional physical assessment
timeFrame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
measure: Changes in the 30 second chair stand functional physical assessment
timeFrame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
measure: Changes in the timed up and go functional physical assessment
timeFrame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
measure: Changes in the two minute step up functional physical assessment
timeFrame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
measure: Changes in the balance functional physical assessment
timeFrame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
measure: Change in the BMI body composition
timeFrame: Change from Baseline body composition components at 6 months
measure: Change in the percentage of body fat of body composition
timeFrame: Change from Baseline body composition components at 6 months
measure: Change in the body fat mass of body composition
timeFrame: Change from Baseline body composition components at 6 months
measure: Change in the lean body mass of body composition
timeFrame: Change from Baseline body composition components at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
name: Valeria JY Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.