Back to resultsPrader-Willi Syndrome Body Composition
Primary Purpose
Prader Labhart Willi Syndrome, Body Weight Changes, Sarcopenia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Therapeutic elastic band resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Prader Labhart Willi Syndrome focused on measuring Prader Willi Syndrome, Body composition, Sarcopenia, Resistance training, Physical capacity
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.
Sites / Locations
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Elastic band (EB)
Control group (CG)
Arm Description
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.
Control group participants will receive usual care.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
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.
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.
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.
Full Information
NCT ID
NCT04597645
First Posted
August 21, 2020
Last Updated
October 20, 2020
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04597645
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader Labhart Willi Syndrome, Body Weight Changes, Sarcopenia
Keywords
Prader Willi Syndrome, Body composition, Sarcopenia, Resistance training, Physical capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elastic band (EB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
Control group participants will receive usual care.
Intervention Type
Other
Intervention Name(s)
Therapeutic elastic band resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in lean tissue mass and adipose tissue mass
Description
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
Title
Change in body mass index
Description
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
Secondary Outcome Measure Information:
Title
Change in grip muscle strength
Description
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
Title
Change in 30-second sit to stand test
Description
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
Title
Change in timed up and go test
Description
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
Title
Change in two minute step up test
Description
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
Title
Change in Berg balance scale
Description
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
Title
Change in lipid profile
Description
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
Title
Change in fasting glucose
Description
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
Title
Change in glycated hemoglobin
Description
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
Other Pre-specified Outcome Measures:
Title
Change in appendicular skeletal muscle mass and lower extremity skeletal muscle mass
Description
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
Title
Change in skeletal muscle mass index and lower extremity skeletal muscle mass index
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valeria Chiu, M.D
Phone
+886-266289779
Ext
67702
Email
haydenbell28@gmail.com
Facility Information:
Facility Name
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) is not planned to be shared.
Learn more about this trial
Prader-Willi Syndrome Body Composition
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