Prader-Willi Syndrome Body Composition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prader Labhart Willi Syndrome, Body Weight Changes, Sarcopenia

Intervention / Treatment
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* Other: Therapeutic elastic band resistance training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastic band (EB)<br>EB group participants who are attending sheltered employment will received Elastic Thera band training program two times per week (once supervised and guided by a trained physical therapist and the other supervised by educational trainer) over 16 weeks for a total of 32 sessions. | Other: Therapeutic elastic band resistance training<br>* 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.<br>|
| No Intervention: Control group (CG)<br>Control group participants will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean tissue mass and adipose tissue mass | Lean tissue mass and adipose tissue mass will be determined by dual energy x-ray absorptiometry (DXA) (Hologic Densitometer Discovery A, USA). | Baseline and 4 month follow up | 
| Change in body mass index | Body mass index will be calculated as the body mass in kilograms divided by the square of the height in meters. | Baseline and 4 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grip muscle strength | 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. | Baseline and 4 month follow up | 
| Change in 30-second sit to stand test | The 30-second sit to stand test assesses endurance by counting the number of sit to stand ups achieved. | Baseline and 4 month follow up | 
| Change in timed up and go test | 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. | Baseline and 4 month follow up | 
| Change in two minute step up test | 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). | Baseline and 4 month follow up | 
| Change in Berg balance scale | 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. | Baseline and 4 month follow up | 
| Change in lipid profile | 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. | Baseline and 4 month follow up | 
| Change in fasting glucose | 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. | Baseline and 4 month follow up | 
| Change in glycated hemoglobin | 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. | Baseline and 4 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prader Willi Syndrome, Body composition, Sarcopenia, Resistance training, Physical capacity