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 range18 Years – 50 Years
SexALL
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.
Exclusion criteria
✕. Use of beta-blocker medications;
✕. Psychological or psychiatric disorders;
✕. 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;
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