NCT03565081

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
Last Updated

June 21, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 28, 2018

Last Update Submit

June 11, 2018

Conditions

Prader-Willi SyndromeResistance Training

Keywords

Prader-Willi SyndromeResistance TrainingBody Composition

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (1)

PWS elastic band training group

EXPERIMENTAL

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

Interventions

PWS elastic band training groupDEVICE

PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.

PWS elastic band training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PWS individuals who can cooperate with motor performances

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 16509530RESULT

  • 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.

    PMID: 12520259RESULT

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Valeria JY Chiu, MD

    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 21, 2018

Study Start

February 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 21, 2018

Record last verified: 2018-05