Clinical trial NCT02622438: Routine Health Care of Patients With FSHD
Official title: Course and Follow up of Patients Affected by Facioscapulohumeral Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Disease Fascioscapulohumeral Dystrophy (FSHD)
Keywords: FSHD
Usual care performed at Montpellier hospital
Muscle function
Antioxidants
Oxidative stress
Quality of life
Physical activities, development of food-based dietary guidelines
Co-morbidity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 189
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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)

Primary outcomes:
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 1 day (the day of inclusion)
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 12 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 24 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 36 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 48 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
timeFrame: 60 months after inclusion
Secondary outcomes:
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 1 day (the day of inclusion)
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 12 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 24 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 36 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 48 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
timeFrame: 60 months after inclusion
measure: Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
timeFrame: 1 day (the day of inclusion)
measure: Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)
timeFrame: 12 months after inclusion
measure: Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
timeFrame: 24 months after inclusion
measure: Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
timeFrame: 36 months after inclusion
measure: Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
timeFrame: 48 months after inclusion
measure: Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
timeFrame: 60 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 1 day (the day of inclusion)
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 12 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 24 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 36 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 48 months after inclusion
measure: Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
timeFrame: 60 months after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital- Saint Eloi Hospital
state: Languedoc-Roussillon
Study officials:
affiliation: CHRU de Montpellier
name: Jacques MERCIER, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: