Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000107426
Ethics application status
Approved
Date submitted
28/01/2016
Date registered
1/02/2016
Date last updated
14/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and feasibility of progressive resistance training for adolescents and young adults with Prader Willi syndrome
Scientific title
Is progressive resistance training safe and feasible for adolescents and young adults with Prader Willi syndrome? A pilot study
Secondary ID [1] 288433 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prader Willi Syndrome 297452 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297643 297643 0 0
Physiotherapy
Human Genetics and Inherited Disorders 297663 297663 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group will complete a 10-week progressive resistance training program. They will be taught 7 exercises: three exercises for the upper limbs, three exercises for the lower limbs and one exercise for the trunk. All exercises will be completed on weight machines in a local gymnasium and each exercise session will take approximately 60 minutes. The training program is based on the recommendations of the American College of Sports medicine and will comprise 3 sets of 12 repetitions of each exercise at a training intensity of 12RM. The weight lifted in each exercise will be increased when 3 sets of 12 repetitions of an exercise can be completed. Two-minute rest periods will be given between each exercise set. The program will be conducted twice weekly for 10 consecutive weeks. Participants will complete the program one-on-one with a physiotherapist. Adherence will be monitored using an exercise log-book.
Intervention code [1] 293753 0
Treatment: Other
Comparator / control treatment
Participants in the (waitlist) control group will continue with their typical daily activities, which may include leisure and sporting activities, but will not include a progressive resistance strength training. The control group will be offered the intervention after all assessments have been completed i.e. approximately 12 weeks after the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 297181 0
Muscle force generation (1 repetition maximum of leg press and chest press)
Timepoint [1] 297181 0
At baseline and 1 week after the intervention has ceased
Primary outcome [2] 297199 0
Safety
Timepoint [2] 297199 0
Adverse events will be monitored during the intervention period using exercise log-book and classified as minor/ major; expected/ unexpected; related to the intervention/ unrelated to the intervention. An example of a possible adverse event is delayed onset of muscle soreness which would be anticipated in people who are unaccustomed to exercise, but which would be expected to resolve quickly and not interfere with training.
Primary outcome [3] 297200 0
Feasibility
Timepoint [3] 297200 0
Will be measured during the intervention phase of the trial by documentation in the exercise log-books of attendance at the exercise sessions and adherence to the exercise protocol.
Secondary outcome [1] 320255 0
Body composition (waist circumference)
Timepoint [1] 320255 0
At baseline and 1 week after the intervention has ceased
Secondary outcome [2] 320256 0
Muscle composition (ultrasound of quadriceps and biceps muscles)
Timepoint [2] 320256 0
At baseline and 1 week after the intervention has ceased
Secondary outcome [3] 320257 0
Muscle performance (box stacking task and timed stair climb)
Timepoint [3] 320257 0
At baseline and 1 week after the intervention has ceased
Secondary outcome [4] 320258 0
Physical activity (accelerometry)
Timepoint [4] 320258 0
7-days at baseline and 1 week after the intervention has ceased
Secondary outcome [5] 320327 0
Body composition (BMI)
Timepoint [5] 320327 0
At baseline and 1 week after the intervention has ceased
Secondary outcome [6] 320328 0
Body composition (DXA whole body scan)
Timepoint [6] 320328 0
At baseline and 1 week after the intervention has ceased

Eligibility
Key inclusion criteria
(1) Ability to follow simple instructions in English, (2) fit and well enough to participate in a strength training program and (3) a diagnosis of Prader Willi syndrome
Minimum age
13 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participation in a strength training program in the 3 months prior to the start of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2016
Actual
17/03/2016
Date of last participant enrolment
Anticipated
Actual
31/08/2016
Date of last data collection
Anticipated
31/01/2017
Actual
23/12/2016
Sample size
Target
22
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292776 0
Charities/Societies/Foundations
Name [1] 292776 0
Jack Brockhoff Foundation
Country [1] 292776 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 291512 0
None
Name [1] 291512 0
No secondary sponsor
Address [1] 291512 0
No secondary sponsor
Country [1] 291512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294271 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 294271 0
La Trobe University,
Kingsbury Drive,
Bundoora
Victoria 3086.
Ethics committee country [1] 294271 0
Australia
Date submitted for ethics approval [1] 294271 0
20/11/2015
Approval date [1] 294271 0
17/12/2015
Ethics approval number [1] 294271 0
HEC15-115

Summary
Brief summary
This pilot randomised controlled trial will be the first to investigate if supervised progressive resistance training (strength training) is safe and feasible for adolescents and young adults with Prader Willi syndrome aged 13-39 years. It will also investigate the effect of the training on body composition (including muscle mass), muscle strength, muscle performance, and physical activity.
Twenty-two adolescents and young adults with Prader Willi syndrome will be recruited through the Prader Willi Syndrome Association of Victoria and through the Prader Willi Syndrome register. Participants will be randomly allocated to either a 10-week twice a week community gymnasium based progressive resistance training program supervised by a physiotherapist (n=11) or a waitlisted control group (n=11). The training program will comprise 7 exercises on pin-loaded weight machines: 3exercises for the arms, 3 exercises for the legs and 1 exercise for the trunk which will take 45-60 minutes to complete each session. Participants will be assessed before they start the intervention and again after they complete the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63130 0
Prof Nora Shields
Address 63130 0
School of Allied Health, La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 63130 0
Australia
Phone 63130 0
+61 3 9479 5852
Fax 63130 0
Email 63130 0
[email protected]
Contact person for public queries
Name 63131 0
Prof Nora Shields
Address 63131 0
School of Allied Health, La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 63131 0
Australia
Phone 63131 0
+61 3 9479 5852
Fax 63131 0
Email 63131 0
[email protected]
Contact person for scientific queries
Name 63132 0
Prof Nora Shields
Address 63132 0
School of Allied Health, La Trobe University, Kingsbury Drive, Bundoora, VIC 3086
Country 63132 0
Australia
Phone 63132 0
+61 3 9479 5852
Fax 63132 0
Email 63132 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs strength training feasible for young people with Prader-Willi syndrome? A phase I randomised controlled trial.2020https://dx.doi.org/10.1016/j.physio.2019.01.016
N.B. These documents automatically identified may not have been verified by the study sponsor.