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Completed

NCT Number: NCT03565081

Effects of Progressive Elastic Band Resistance Training

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Resistance Training

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PWS elastic band training group

Device

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

Primary outcomes

  1. Changes in the handgrip strength functional physical assessment

    Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

    hand grip strength (pounds),

  2. Changes in the 30 second chair stand functional physical assessment

    Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

    30-second chair stand test (times)

  3. Changes in the timed up and go functional physical assessment

    Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

    timed up-and-go test (seconds)

  4. Changes in the two minute step up functional physical assessment

    Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks

    2 minute step up test (times)

  5. Changes in the balance functional physical assessment

    Time frame: 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)

  6. Change in the BMI body composition

    Time frame: Change from Baseline body composition components at 6 months

    Body weight (km) and height (m) will be combined to report as BMI (kg/m2)

  7. Change in the percentage of body fat of body composition

    Time frame: Change from Baseline body composition components at 6 months

    Regional percentage body fat (%)

  8. Change in the body fat mass of body composition

    Time frame: Change from Baseline body composition components at 6 months

    Fat mass (kg)

  9. Change in the lean body mass of body composition

    Time frame: Change from Baseline body composition components at 6 months

    Lean body mass (kg)

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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