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Completed

NCT Number: NCT04597645

Prader-Willi Syndrome Body Composition

Adults aged over 18 years, with the diagnosis of Prader-willi syndrome will be recruited through the hospital's outpatient clinic for either as intervention group receiving therapeutic elastic band training, or as control group receiving usual care for a total of 16 weeks. Body composition, physical capacity, and serum changes will be assessed before and after the intervention.

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Key information

About this study

Participants that fulfill the inclusion criteria will be assigned into one of the two arms: elastic band intervention group (EB) or control group (CG). Both groups will received a baseline: dual X-ray absorptiometry body composition, physical capacity, and serum markers examinations. EB will then receive a 16-week progressive elastic band resistance exercise training, while the CG will receive usual care. After the 16 weeks from the baseline assessment, a followed-up: dual X-ray absorptiometry body composition, physical capacity, and serum examinations will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-65 years old.
  • Genetically diagnosis of Prader-willi syndrome.
  • Must be able to follow and understand mandarin instructions and cooperate to the exercise assessments and/or training.

Exclusion criteria

  • Prader-willi syndrome individuals unable to sit, stand and walk independently which make physical capacity assessment difficult.
  • Severe arthritis, fracture, or other musculoskeletal deformities that interfere with exercise training.
  • Severe cognitive impairment who cannot read, write the informed consent.

Treatment and study plan

Therapeutic elastic band resistance training

Other

A16-week therapeutic program using Elastic Thera Band will be taught. The exercises are designed to train specific major muscle groups, strengthen the motivation of participants, and facilitate home-based compliance. The program will be performed two times per week (once supervised and guided by a trained physical therapist and the other supervised by educational trainers) over 16 weeks for a total of 32 sessions. Each session supervised by a physical therapist last for 60 minutes, including a 5-minute warm-up consisting of light-intensity aerobic and dynamic stretching exercises, followed by 50 minutes of EB exercise and a 5-minute period of cool-down and static stretching exercises.

Primary outcomes

  1. Change in lean tissue mass and adipose tissue mass

    Time frame: Baseline and 4 month follow up

    Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA).

  2. Change in body mass index

    Time frame: Baseline and 4 month follow up

    Body mass index will be calculated as the body mass in kilograms divided by the square of the height in meters.

Secondary outcomes

  1. Change in grip muscle strength

    Time frame: Baseline and 4 month follow up

    A baseline hydraulic dynamometer will be used to assess the grip muscle strength. The upper extremity muscle quality (ratio of muscular strength to muscle mass) will be calculated by dividing handgrip strength by arm lean mass.

  2. Change in 30-second sit to stand test

    Time frame: Baseline and 4 month follow up

    The 30-second sit to stand test assesses endurance by counting the number of sit to stand ups achieved.

  3. Change in timed up and go test

    Time frame: Baseline and 4 month follow up

    The timed up and go test measures the time required to rise from a chair, walk a 3-meter-long line on the floor, turn around, walk back, and sit down again.

  4. Change in two minute step up test

    Time frame: Baseline and 4 month follow up

    The two minute step up test measures aerobic endurance by having the subject marching in place for two minutes, lifting alternatively the knees to a midway between patella and iliac crest height of a tape (marked at the wall).

  5. Change in Berg balance scale

    Time frame: Baseline and 4 month follow up

    Berg balance scale assesses simple mobility function tasks (sit unsupported, sit-to-stand, stand to sit, stand unsupported, transfer, stand with eyes closed and feet together) and more difficult balance tasks (turn to look behind, retrieve object from floor, turn 360 degrees, reach forward with an outstretched arm, tandem stand, place alternate foot on stool, and single leg stand). It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. A maximum scoring of 56 indicates functional balanced, while scoring< 45 indicates higher risk of falling.

  6. Change in lipid profile

    Time frame: Baseline and 4 month follow up

    Measurements of serum levels of total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein will be determined using biochemical automatic analyzer according to the manufacturer's recommendations and established methods in the literature.

  7. Change in fasting glucose

    Time frame: Baseline and 4 month follow up

    Measurements of serum levels of fasting glucose will be determined using biochemical automatic analyzer according to the manufacturer's recommendations and established methods in the literature.

  8. Change in glycated hemoglobin

    Time frame: Baseline and 4 month follow up

    Measurements of the glycated hemoglobin (HbA1c) of fasting glucose will be determined using biochemical automatic analyzer according to the manufacturer's recommendations and established methods in the literature.

Other outcomes

  1. Change in appendicular skeletal muscle mass and lower extremity skeletal muscle mass

    Time frame: Baseline and 4 month follow up

    The appendicular skeletal muscle mass (ASM) will be obtained from the dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA) measurement, excluding the bone mass from the mass of the extremities, from which fat mass is already excluded. ASM (kg)=lean body mass of extremity - bone mass of extremity.

    The lower extremity skeletal muscle mass (LESM) will be obtained from the dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA) measurement, by excluding the bone mass of the lower extremity, from which fat mass is already excluded. LESM (kg)=lean body mass of lower extremity - bone mass of lower extremity.

  2. Change in skeletal muscle mass index and lower extremity skeletal muscle mass index

    Time frame: Baseline and 4 month follow up

    Skeletal muscle mass index (SMI) (%) will be calculated using the values measured via the dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA) as follow= ASM (kg)/body weight (kg)×100 Lower extremity skeletal muscle mass (LESM) (%) will be calculated using the values measured via the dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA) as follow= LESM (kg)/lower extremity body weight (kg)×100)

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

Effects of Therapeutic Elastic Band Training on Body Composition and Physical Capacity in Adults With Prader-Willi Syndrome

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
May 3, 2024

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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