Prader Labhart Willi SyndromeNCT04597645
Prader-Willi Syndrome Body Composition
A study testing Therapeutic elastic band resistance training in people with Prader Labhart Willi Syndrome and Body Weight Changes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prader Labhart Willi Syndrome, Body Weight Changes, Sarcopenia
- What is being tested?
- Therapeutic elastic band resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 May 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, 231
About this study
Official title: 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.
Read the 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.
- Being tested
- Therapeutic elastic band resistance training
- Keywords
- Prader Willi Syndrome, Body composition, Sarcopenia, Resistance training, Physical capacity
- Medical subject headings
- Prader-Willi Syndrome, Body Weight Changes, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic elastic band resistance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Elastic band (EB) | Experimental | 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. Receives: Other: Therapeutic elastic band resistance training |
| Control group (CG) | No intervention | Control group participants will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and 4 month follow up
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start6 May 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader Labhart Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valeria Chiu, MD, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597645
- Sponsor's protocol ID
- TCRD-TPE-109-55
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) is not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Elastic Band Training on Body Composition and Physical Capacity in Adults With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT04597645
- Acronym / sponsor ID
- TCRD-TPE-109-55
- Keywords
- Prader Willi Syndrome, Body composition, Sarcopenia, Resistance training, Physical capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic band (EB) | Experimental | Other: Therapeutic elastic band resistance trainingEB 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 (CG) | No intervention | –Control group participants will receive usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic elastic band resistance trainingA16-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. | Other | Elastic band (EB) |
Primary outcome
Change in lean tissue mass and adipose tissue mass
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).
Change in body mass index
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.
8 secondary outcomes
Change in grip muscle strength
Time frame: Baseline and 4 month follow up
Change in 30-second sit to stand test
Time frame: Baseline and 4 month follow up
Change in timed up and go test
Time frame: Baseline and 4 month follow up
Change in two minute step up test
Time frame: Baseline and 4 month follow up
Change in Berg balance scale
Time frame: Baseline and 4 month follow up
Change in lipid profile
Time frame: Baseline and 4 month follow up
Change in fasting glucose
Time frame: Baseline and 4 month follow up
Change in glycated hemoglobin
Time frame: Baseline and 4 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No. The individual participant data (IPD) is not planned to be shared.
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Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Chiu, MD principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic elastic band resistance training in people with Prader Labhart Willi Syndrome and Body Weight Changes, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean tissue mass and adipose tissue mass (time frame: Baseline and 4 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.