Effects of Progressive Elastic Band Resistance Training

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

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.

Study Overview

• Status: Completed
• Conditions: Prader-Willi Syndrome; Resistance Training
• Intervention / Treatment: Device: PWS elastic band training group

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Change in the percentage of body fat of body composition	Regional percentage body fat (%)	Change from Baseline body composition components at 6 months
Change in the body fat mass of body composition	Fat mass (kg)	Change from Baseline body composition components at 6 months
Change in the lean body mass of body composition	Lean body mass (kg)	Change from Baseline body composition components at 6 months

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Principal Investigator: Valeria JY Chiu, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Body Composition; Resistance Training; Prader-Willi Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Syndrome; Prader-Willi Syndrome
• Other Study ID Numbers: 04-XD33-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No