Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, 231, Taiwan
NCT Number: NCT04597645
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New Taipei City, 231, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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)
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Other
Effects of Therapeutic Elastic Band Training on Body Composition and Physical Capacity in Adults With Prader-Willi Syndrome
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.
Published trials that share one or more normalized conditions with this study.
NCT03551132
Atrophy, Body Weight
Murcia, Spain
View Trial DetailsNCT06448871
Abnormalities, Multiple, Atrophy
New Taipei City, Taiwan
View Trial DetailsNCT07580144
Atrophy, Frailty
Konya, Turkey (Türkiye)
View Trial DetailsNCT06629805
Atrophy, Muscular Atrophy
Yangsan, South Korea
View Trial Details