Prader-Willi Syndrome Body Composition

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

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.

Study Overview

• Status: Unknown
• Conditions: Body Weight Changes; Sarcopenia; Prader Labhart Willi Syndrome
• Intervention / Treatment: Other: Therapeutic elastic band resistance training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valeria Chiu, M.D; Phone Number: 67702 +886-266289779; Email: haydenbell28@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 231
    • Recruiting
    • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elastic band (EB); 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; 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.
No Intervention: Control group (CG); Control group participants will receive usual care.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Body composition; Sarcopenia; Resistance training; Physical capacity; Prader Willi Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Intellectual Disability; Muscular Atrophy; Atrophy; Abnormalities, Multiple; Chromosome Disorders; Obesity; Syndrome; Body Weight; Sarcopenia; Body Weight Changes; Prader-Willi Syndrome
• Other Study ID Numbers: TCRD-TPE-109-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) is not planned to be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No