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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
189
Montpellier University Hospital- Saint Eloi Hospital
Montpellier, Languedoc-Roussillon, France
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
Time frame: 60 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)
Time frame: 60 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)
Time frame: 12 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 24 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 36 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 48 months after inclusion
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)
Time frame: 60 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 1 day (the day of inclusion)
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 12 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 24 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 36 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 48 months after inclusion
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests
Time frame: 60 months after inclusion
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