Course and Follow up of Patients Affected by Facioscapulohumeral Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Molecular and clinical diagnosis for FSHD
- •patients, men and women aged > 7 years,
排除标准
- •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)
结局指标
主要结局
Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg
时间窗: 60 months after inclusion
次要结局
- 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)