None listed
Conditions
Brief summary
We will investigate if exercise is effective in increasing muscle strength in people with Prader-Willi syndrome (PWS). We will conduct a phase II, multi-site, double-blind, randomised controlled trial with 6-month follow-up. Sixty participants with PWS aged 13 to 60 years will be randomised to receive one of two exercise programs. Participants will exercise twice a week for 24 weeks at their local gym supervised by an exercise health professional (usually a physiotherapist). We will measure muscle strength, muscle mass, functional strength, physical activity, community participation, and health-related quality of life at baseline (week 0), after the intervention (week 25) and 6 months later (week 52): We will recruit participants through PWS advocacy groups, specialist PWS clinics, and PWS registries and clinical databases.
Interventions
Participants will be randomised to receive one of two exercises programs.
Intervention group participants will complete a progressive resistance training program, supervised 1:1 by an exercise professional.
Participants will exercise twice a week for 24 weeks (48 sessions in total). Each exercise session will last approximately 60 minutes. The program, designed according to American College of Sports Medicine guidelines, will comprise 6 exercises to strengthen the major multi-joint muscles of th
Participants will be randomised to receive one of two exercises programs. Intervention group participants will complete a progressive resistance training program, supervised 1:1 by an exercise professional. Participants will exercise twice a week for 24 weeks (48 sessions in total). Each exercise session will last approximately 60 minutes. The program, designed according to American College of Sports Medicine guidelines, will comprise 6 exercises to strengthen the major multi-joint muscles of the upper and lower limbs. Participants will perform 3 exercises for the upper limbs (e.g. lat pull down, seated chest press, seated row) and 3 exercises for the lower limbs (e.g. seated leg press, seated calf raise, hip abduction). Exercises will be performed on pin-loaded weight machines as they are safer than free weights for novice participants. Exercises can be modified to suit the availability of training equipment at a particular gymnasium. Participants will perform up to 3 sets of 12 repetitions of each exercise until fatigue (intensity of 60-80% of 1 repetition maximum-1RM). A 2-minute rest will be taken between each set to allow for recovery, and resistance will be increased when 3 sets of 12 repetitions of an exercise can be completed. All exercise sessions will take place in a community gym local to the participant. The exercise program will be supervised by an exercise professional (usually a physiotherapist, exercise physiologist or personal trainer). Exercise professionals will be invited to participate based on their location and typical practice (e.g. working in paediatrics, neurological, or musculoskeletal areas). They will receive a training manual that includes details about the trial protocol, specialist advice on Prader-Willi syndrome, how to facilitate exercise in people with Prader-Willi syndrome, communication strategies, and behaviour management. The exercise professional will complete an exercise log (either in hard copy or online) on behalf of the participant to document the exercises completed and any adverse events that occur. Participants will also receive 2 planning sessions of 1-hour duration following the intervention period with a facilitator to encourage their ongoing participation in community exercise. These sessions will be conducted by an exercise professional either in person or via videoconference. The content of these sessions will be individualised and will aim to address barriers to taking part in ongoing community exercise identified by each participant and their families. This may include information on accessing available community resources to support ongoing participation. These sessions will take place approximately 1 month and 3 months after the end of the intervention.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Each participant must meet all of the following criteria to be enrolled in this trial: • Have genetically confirmed Prader-Willi syndrome, • Aged between 13 and 60 years (inclusive) at the time of randomisation, • Able to follow simple verbal instructions in English, • Medical clearance from their general practitioners or physician certifying they can participate (where considered necessary based on answers to the pre-exercise screening questionnaire PAR-Q+), • Provide a signed and dated informed consent form or has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Exclusion criteria
People meeting any of the following criteria will be excluded from the trial: • Has participated in progressive resistance training in the 3 months prior to randomisation • Has a concurrent physical (e.g. severe arthritis), psychological (e.g. severe psychosis) or behavioural issue (e.g. violent behaviour) that might affect their ability to participate in a 24-week exercise program. • Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
Outcome results
None listed