Prader-Willi SyndromeNCT03565081
Effects of Progressive Elastic Band Resistance Training
A study testing PWS elastic band training group in people with Prader-Willi Syndrome and Resistance Training, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prader-Willi Syndrome, Resistance Training
- What is being tested?
- PWS elastic band training group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Dec 2016
- 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
- PWS individuals who can cooperate with motor performances
Who cannot join
- arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance
- severe cognitive impairment or parents who cannot read nor write.
About this study
Official title: Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study
Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. The aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with PWS.
Read the detailed description
Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, BMI, and regional extremities fat mass and percentage. Regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. Balance function achieved significant improvements after 16 weeks of training.
- Conditions
- Prader-Willi Syndrome, Resistance Training
- Being tested
- PWS elastic band training group
- Keywords
- Prader-Willi Syndrome, Resistance Training, Body Composition
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PWS elastic band training groupDevice
PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.
| Study group | Role | What they receive |
|---|---|---|
| PWS elastic band training group | Experimental | Genetically confirmed diagnosis of PWS participants were recruited. The PWS participants needed to have sufficient command of the Mandarin language to understand the study information and motivated to conduct the training program. Receives: Device: PWS elastic band training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the handgrip strength functional physical assessment
hand grip strength (pounds),
Measured: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Changes in the 30 second chair stand functional physical assessment
30-second chair stand test (times)
Measured: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Changes in the timed up and go functional physical assessment
timed up-and-go test (seconds)
Measured: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Changes in the two minute step up functional physical assessment
2 minute step up test (times)
Measured: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Changes in the balance functional physical assessment
Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)
Measured: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Change in the BMI body composition
Body weight (km) and height (m) will be combined to report as BMI (kg/m2)
Measured: Change from Baseline body composition components at 6 months
Change in the percentage of body fat of body composition
Regional percentage body fat (%)
Measured: Change from Baseline body composition components at 6 months
Change in the body fat mass of body composition
Fat mass (kg)
Measured: Change from Baseline body composition components at 6 months
Change in the lean body mass of body composition
Lean body mass (kg)
Measured: Change from Baseline body composition components at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Feb 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prader-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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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 JY Chiu, MD, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565081
- Sponsor's protocol ID
- 04-XD33-100
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schlumpf M, Eiholzer U, Gygax M, Schmid S, van der Sluis I, l'Allemand D. A daily comprehensive muscle training programme increases lean mass and spontaneous activity in children with Prader-Willi syndrome after 6 months. J Pediatr Endocrinol Metab. 2006 Jan;19(1):65-74. doi: 10.1515/jpem.2006.19.1.65.
PubMed 16509530Eiholzer U, Nordmann Y, l'Allemand D, Schlumpf M, Schmid S, Kromeyer-Hauschild K. Improving body composition and physical activity in Prader-Willi Syndrome. J Pediatr. 2003 Jan;142(1):73-8. doi: 10.1067/mpd.2003.mpd0334.
PubMed 12520259
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Elastic Band Resistance Training on Body Composition and Motor Performance in Adults With Prader-Willi Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT03565081
- Acronym / sponsor ID
- 04-XD33-100
- Conditions
- Prader-Willi Syndrome, Resistance Training
- Keywords
- Prader-Willi Syndrome, Resistance Training, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 21 Jun 2018 (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.
Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment. The aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with PWS.
Detailed description
Six participants were enrolled in this pilot study. Following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, BMI, and regional extremities fat mass and percentage. Regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. Balance function achieved significant improvements after 16 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PWS elastic band training group | Experimental | Device: PWS elastic band training groupGenetically confirmed diagnosis of PWS participants were recruited. The PWS participants needed to have sufficient command of the Mandarin language to understand the study information and motivated to conduct the training program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PWS individuals who can cooperate with motor performances
Key exclusion criteria (2 listed)
- arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance
- severe cognitive impairment or parents who cannot read nor write.
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 |
|---|---|---|
| PWS elastic band training groupPWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions. | Device | PWS elastic band training group |
Primary outcome
Changes in the handgrip strength functional physical assessment
Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
hand grip strength (pounds),
Changes in the 30 second chair stand functional physical assessment
Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
30-second chair stand test (times)
Changes in the timed up and go functional physical assessment
Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
timed up-and-go test (seconds)
Changes in the two minute step up functional physical assessment
Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
2 minute step up test (times)
Changes in the balance functional physical assessment
Time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks
Berg Balance Scale (0-56 points; 0-20= high fall risk; 21-40= medium fall risk; 41-56= low fall risk)
Change in the BMI body composition
Time frame: Change from Baseline body composition components at 6 months
Body weight (km) and height (m) will be combined to report as BMI (kg/m2)
Change in the percentage of body fat of body composition
Time frame: Change from Baseline body composition components at 6 months
Regional percentage body fat (%)
Change in the body fat mass of body composition
Time frame: Change from Baseline body composition components at 6 months
Fat mass (kg)
Change in the lean body mass of body composition
Time frame: Change from Baseline body composition components at 6 months
Lean body mass (kg)
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 21 Jun 2018.
- Results publication: PubMed 16509530Schlumpf M, Eiholzer U, Gygax M, Schmid S, van der Sluis I, l'Allemand D. A daily comprehensive muscle training programme increases lean mass and spontaneous activity in children with Prader-Willi syndrome after 6 months. J Pediatr Endocrinol Metab. 2006 Jan;19(1):65-74. doi: 10.1515/jpem.2006.19.1.65.
- Results publication: PubMed 12520259Eiholzer U, Nordmann Y, l'Allemand D, Schlumpf M, Schmid S, Kromeyer-Hauschild K. Improving body composition and physical activity in Prader-Willi Syndrome. J Pediatr. 2003 Jan;142(1):73-8. doi: 10.1067/mpd.2003.mpd0334.
- Individual participant dataSharing planned: Undecided
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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 JY Chiu, MD principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
Questions about this trial
What is this clinical trial studying?
A study testing PWS elastic band training group in people with Prader-Willi Syndrome and Resistance Training, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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 1 inclusion and 2 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in the handgrip strength functional physical assessment (time frame: Changes from Baseline functional motor performance tests at 8 weeks, 16 weeks and 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565081, which also lists 2 linked publications.
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 21 Jun 2018.