Amino Acids and Exercise in FSHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Pavia
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Essential Amino Acids Supplementation intervention
- Exercise
- Diet
- Placebo Control
Treatment groups
48 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov