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NCT Number: NCT01990976

Study of Morphology and Functional Magnetic Resonance Imaging (MRI) Muscle Patients With Muscular Dystrophy Type FSHD Benefiting a Physical Training Introduced.

The safety of guided practice of physical activity in myopathies is increasingly accepted, including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most common muscular dystrophy, the aerobic training showed its physiological and functional efficiency without affecting the quality of life of patients. The issue of exercise therapy extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use of a training program combining endurance exercise targeted exercises and strength is even more relevant.

To complete the multidimensional assessments be managed by each team ( physiological assessments, functional tissue and quality of life) it is relevant to continue , for a descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).

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Key information

Conditions

Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Facioscapulohumeral Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Grenbole, Grenoble, France

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About this study

These non-invasive assessments already in place at the time of the initial training (FSHD1 study, NCT01116570) will be repeated in the medium (12 months) and long term (30 months) in the same laboratory NMR AIM - CEA , Institute of Myology in Paris (P Carlier ). The data obtained from NMR repeated examinations and those obtained from biochemical analyzes and additional muscle histomorphometric (cellular aging estimation of involution fibroadipose ) on biopsies already programmed (initial, 6 months and 30 months, FSHD2 study, NCT01689480) will be respectively compared to initial time to follow the evolution food and energy capacity of trained muscles. The study of biopsies provide mechanistic arguments and morphometric specific cellular response to exercise, data will be advantageously complemented by NMR specialized examinations extended to all the muscles of the thigh (target of training ) and muscle quantification whole body MRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Included in the FSHD1 and FSHD2 studies
  • Social Security regimen affiliated
  • Consent form signed

Exclusion criteria

  • Severe cardiac or respiratory insufficiency
  • Cardiac pacemaker
  • Morbid obesity (BMI upper to 35)
  • Anti platelet therapy

Treatment and study plan

MRI

Device

In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.

Biopsy

Procedure

biopsy of the vastus lateralis muscle

Primary outcomes

  1. Parameters of MRI

    Time frame: 30 months

    whole body imaging T1, T2-weighted

Secondary outcomes

  1. Muscle tissue parameters

    Time frame: 30 months

    muscle biopsy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris
  • Ministry of Health, France

Registry information

Acronym: FSHD3

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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