Routine Health Care of Patients With FSHD

University Hospital Center (CHU)

Status: Completed

Conditions: Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Treatments: Other: Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.

Study type: Interventional

Funder types: Other

Identifiers

NCT02622438

9371

Details and patient eligibility

About

On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

Full description

This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up

Enrollment: 189 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Molecular and clinical diagnosis for FSHD
• patients, men and women aged > 7 years,

Exclusion criteria

• pregnant women
• Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
• Major protected by law (guardianship, curatorship or under judicial protection)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 1 patient group

Course and follow up of patients affected by FSHD

Other group

Treatment:

Other: Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.