Clinical trial NCT04597645: Prader-Willi Syndrome Body Composition
Official title: Effects of Therapeutic Elastic Band Training on Body Composition and Physical Capacity in Adults With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prader Labhart Willi Syndrome
Body Weight Changes
Sarcopenia
Keywords: Prader Willi Syndrome
Body composition
Sarcopenia
Resistance training
Physical capacity
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in lean tissue mass and adipose tissue mass
timeFrame: Baseline and 4 month follow up
measure: Change in body mass index
timeFrame: Baseline and 4 month follow up
Secondary outcomes:
measure: Change in grip muscle strength
timeFrame: Baseline and 4 month follow up
measure: Change in 30-second sit to stand test
timeFrame: Baseline and 4 month follow up
measure: Change in timed up and go test
timeFrame: Baseline and 4 month follow up
measure: Change in two minute step up test
timeFrame: Baseline and 4 month follow up
measure: Change in Berg balance scale
timeFrame: Baseline and 4 month follow up
measure: Change in lipid profile
timeFrame: Baseline and 4 month follow up
measure: Change in fasting glucose
timeFrame: Baseline and 4 month follow up
measure: Change in glycated hemoglobin
timeFrame: Baseline and 4 month follow up
Other outcomes:
measure: Change in appendicular skeletal muscle mass and lower extremity skeletal muscle mass
timeFrame: Baseline and 4 month follow up
measure: Change in skeletal muscle mass index and lower extremity skeletal muscle mass index
timeFrame: Baseline and 4 month follow up
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Valeria Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References: