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

NCT01990976 | Completed

• 2 other identifiers: 12080502012-A00430-43
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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 ).

Conditions

Muscular Dystrophy; Facioscapulohumeral

Keywords

Muscular Dystrophy; Facioscapulohumeral; Physical training; Magnetic Resonance Imaging; Muscle Biopsy

Outcome Measures

Primary Outcomes (1)

• Parameters of MRI

  whole body imaging T1, T2-weighted

  30 months

Secondary Outcomes (1)

• Muscle tissue parameters

  30 months

Study Arms (1)

FSHD training

Only the patients who have participated to the FSHD1 study (NCT01116570) and the FSHD2 study (NCT01689480) can be included in this study.

Device: MRI; Procedure: Biopsy

Interventions

MRI DEVICE

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

FSHD training

Biopsy PROCEDURE

biopsy of the vastus lateralis muscle

FSHD training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 and FSHD2 studies

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator
• Ministry of Health, France: collaborator

Study Sites (2)

CHU de Grenbole

Grenoble, 38000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscles

MeSH Terms

Conditions

Muscular Dystrophies

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Léonard FEASSON, MD-PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

FR (2)