Routine Health Care of Patients With FSHD

Not Applicable

Completed

• Conditions: Primary Disease Fascioscapulohumeral Dystrophy (FSHD)
• Interventions: Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.

• Registration Number: NCT02622438
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2015-04-19
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Primary Completion: 2024-07-03
• Study Completion: 2024-07-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Course and follow up of patients affected by FSHD	Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.	-

Primary Outcome Measures

Name	Time	Method
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg	60 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)	60 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)	60 months after inclusion
Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)	12 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests	60 months after inclusion

Trial Locations

Locations (1)

Montpellier University Hospital- Saint Eloi Hospital; 🇫🇷 Montpellier, Languedoc-Roussillon, France