[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634694":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":46,"locations":52,"responsibleParty":86,"collaborators":32,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":32,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":32,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":55,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University of Pavia","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise, diet and amino acids in FSHD","EXPERIMENTAL","Effects of exercise, diet and amino acids in FSHD",[13,14,15],"Dietary Supplement: Essential Amino Acids Supplementation intervention","Behavioral: Exercise","Behavioral: Diet",{"label":17,"type":18,"description":19,"interventionNames":20},"Exercise, diet and placebo in FSHD","PLACEBO_COMPARATOR","Effects of exercise, diet and placebo in FSHD",[14,15,21],"Other: Placebo Control",{"label":23,"type":6,"description":24,"interventionNames":25},"Exercise and diet in healthy control","Effects of exercise and diet in healthy control",[14,15],[27,33,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Essential Amino Acids Supplementation intervention","Use of a balanced essential amino acids mixture to counteract muscle deterioration in FSHD",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Exercise","Tailored exercise",[23,9,17],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Diet","Tailored balanced diet",[23,9,17],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Placebo Control","Placebo, diet and exercise in FSHD",[17],[47],{"name":48,"role":49,"phone":50,"phoneExt":32,"email":51},"giuseppe D'Antona, MD, PhD","CONTACT","+39 0383 62053","giuseppe.dantona@unipv.it",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Criams Sport Medicine Centre","RECRUITING","Voghera","Pavia","27058","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],9.01175,44.99151,{"lat":65,"lon":64},[68,71,74,77,80,82,84],{"name":69,"role":49,"phone":70,"phoneExt":32,"email":51},"Guseppe D'Antona, MD, PhD","0039038362053",{"name":72,"role":49,"phone":70,"phoneExt":32,"email":73},"Martina Rossarola","infocriams@gmail.com",{"name":75,"role":76,"phone":32,"phoneExt":32,"email":32},"Oscar Crisafulli, PhD","SUB_INVESTIGATOR",{"name":78,"role":79,"phone":32,"phoneExt":32,"email":32},"Giuseppe D'Antona, MD, PHD","PRINCIPAL_INVESTIGATOR",{"name":81,"role":76,"phone":32,"phoneExt":32,"email":32},"Matteo Fortunati, PhD Student",{"name":83,"role":76,"phone":32,"phoneExt":32,"email":32},"Emanuela Lavaselli, Master in Clinical Nutrition",{"name":85,"role":76,"phone":32,"phoneExt":32,"email":32},"Venere Quintiero, Master in Clinical Nutrition",{"type":87,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100634694","amino-acids-and-exercise-in-fshd-100634694",false,"NCT07543016","Amino Acids and Exercise in FSHD","Amino Acid Supplementation and Physical Exercise in Facioscapulohumeral Muscular Dystrophy: Effects on Body Composition and Physical Efficiency in a Model of Muscular Disease","Inclusion Criteria:\n\n1. Subjects of both sexes with a diagnosis of FSHD, confirmed by genetic testing.\n2. Age between 18 and 50 years.\n3. 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.\n4. Clinical score ranging from 2 to 5.\n5. Preserved ability to walk at the time of enrollment.\n6. Absence of central or peripheral nervous system involvement based on neurological history and physical examination.\n7. Absence of scoliosis, limb contractures, and tendon retractions.\n\nExclusion Criteria:\n\n1. Use of beta-blocker medications;\n2. Psychological or psychiatric disorders;\n3. Musculoskeletal injuries that impair the ability to perform physical exercise;\n4. Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);\n5. Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30 days prior;\n6. Pregnant or breastfeeding women;\n7. Patients unable to understand the purpose and conditions of the study and unable to provide informed consent;\n8. Presence of additional diseases that may interfere with measurements;\n9. Patients deprived of liberty or under legal guardianship.\n\nHealthy participants will be age- and sex-matched adults without neuromuscular disease:\n\n1. no chronic disease;\n2. no neuromuscular disorders;\n3. Same age range.",true,"ALL","18 Years","50 Years",{"count":100,"type":101},48,"ESTIMATED","INTERVENTIONAL",[104],"NA","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.",[107,108],"FSH Muscular Dystrophy","Muscular Dystrophy",[110,111,112,113,114,115,116],"amino acids supplementation","muscular dystrophy","amino acids","exercise","facioscapulohumeral muscular dystrophy","exercise training","nutritional supplementation","2026-04-17",{"date":119,"type":120},"2026-04-21","ACTUAL",{"date":122,"type":120},"2026-04-08",{"date":124,"type":101},"2029-04",{"name":5,"class":6},1]