Amino Acids and Exercise in FSHD (NCT07543016) | Clinical Trial Compass
RecruitingNot Applicable
Amino Acids and Exercise in FSHD
Italy48 participantsStarted 2026-04-08
Plain-language summary
This study evaluates whether amino acid supplementation, combined with a structured diet and exercise program, improves body composition (increased muscle mass and reduced fat mass) and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses to the intervention between individuals with FSHD and healthy individuals matched for age and sex.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects of both sexes with a diagnosis of FSHD, confirmed by genetic testing.
. Age between 18 and 50 years.
. Belonging to clinical category A among the four defined in the Comprehensive Clinical Evaluation Form. These patients present the most characteristic signs of the disease: muscle weakness of the facial and scapular girdle.
. Clinical score ranging from 2 to 5.
. Preserved ability to walk at the time of enrollment.
. Absence of central or peripheral nervous system involvement based on neurological history and physical examination.
. Absence of scoliosis, limb contractures, and tendon retractions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fat mass in FSHD
Timeframe: From enrollment to the end of treatment at 15 months
2
Change in fat-free mass in FSHD
Timeframe: From enrollment to the end of treatment at 15 months
3
Change in aerobic capacity in FSHD
Timeframe: From enrollment to the end of treatment at 15 months
4
Change in muscle strength in FSHD
Timeframe: From enrollment to the end of treatment at 15 months
5
Change in walking performance in FSHD
Timeframe: From enrollment to the end of treatment at 15 months
. Musculoskeletal injuries that impair the ability to perform physical exercise;
. Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);
. Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30 days prior;
. Pregnant or breastfeeding women;
. Patients unable to understand the purpose and conditions of the study and unable to provide informed consent;
. Presence of additional diseases that may interfere with measurements;