Improving muscle strength in young people with Prader-Willi syndrome: a phase II randomised trial

Not Applicable

Active, not recruiting

• Conditions: Prader-Willi syndrome; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12620000416998
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified