Prader-Willi Syndrome Body Composition

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597645
• Other study ID #: TCRD-TPE-109-55
• Status: Completed
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2024
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Prader Labhart Willi Syndrome
• Prader-Willi Syndrome
• Sarcopenia
• Syndrome

Intervention

Other:
• Therapeutic elastic band resistance training
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.

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline and 4 month follow up
Other	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)	Baseline and 4 month follow up
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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