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

Muscular Dystrophy Clinical Trial

— FSHD3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990976
• Other study ID #: 1208050
• Secondary ID: 2012-A00430-43
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: July 27, 2015
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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 ).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Facioscapulohumeral
• Muscular Dystrophies
• Muscular Dystrophy

Intervention

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

Procedure:
• Biopsy
biopsy of the vastus lateralis muscle

Locations

Country	Name	City	State
France	CHU de Grenbole	Grenoble
France	CHU de Saint-Etienne	St Etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Association Française contre les Myopathies (AFM), Paris, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of MRI	whole body imaging T1, T2-weighted	30 months	No
Secondary	Muscle tissue parameters	muscle biopsy	30 months	No