An interventional study of Therapeutic elastic band resistance training in Prader Labhart Willi Syndrome, Body Weight Changes and Sarcopenia, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 99 interventional studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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
Control group participants will receive usual care.
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.
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).
Time frame: 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.
Time frame: Baseline and 4 month follow up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 month follow up
Change in appendicular skeletal muscle mass and lower extremity skeletal muscle mass
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.
Time frame: Baseline and 4 month follow up
Change in skeletal muscle mass index and lower extremity skeletal muscle mass index
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)
Time frame: Baseline and 4 month follow up
Plan to share: No — The individual participant data (IPD) is not planned to be shared.
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Jul 2021, 14 months.
Of 20 interventional studies with no phase under Prader-Willi Syndrome, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's 14 months is below that.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation