Clinical trial NCT01116570: Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients
Official title: Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Facioscapulohumeral
Keywords: Muscular Dystrophy
Facioscapulohumeral
Physical training
Exercise
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Association Française contre les Myopathies (AFM), Paris
name: Örebro University, Sweden
First posted: 2010-05-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.

Detailed description: Our research project aims at establishing a program of physical training that will fulfill the two following conditions: (i) being compatible with the daily professional, social and family activity of the patients so it can be integrated in their life habits and (ii) being intensive enough to induce functional benefits. This experimental work will be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires. This work will be based on a collaboration between the Universities of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes Reference Centre for Rare Neuromuscular Diseases (JC Antoine).

It is accepted that exercise therapy can be recommended for patients with myopathies but long-term training load still has to be determined for each pathology. In the specific context of facioscapulohumeral dystrophy, we aim at associating the scientific evaluation of physical activity benefits and a therapeutic education of patients in order to contribute to recommendations for physicians and physiotherapists. The purpose of this study is to combine an integrated approach with a better understanding of biological process implicated in this physiological treatment strategy.

Eligibility criteria: Inclusion Criteria:

* facioscapulohumeral dystrophy
* Being capable of supporting an exercise on ergocycle
* 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

Primary outcomes:
measure: maximal oxygen uptake (VO2max)
timeFrame: Week 24
Secondary outcomes:
measure: Questionnaire of quality of life
timeFrame: Day 0, Week 6, Week 12, Week 18 and Week 24
measure: Biopsy
timeFrame: Day 0 and Week 24
measure: maximal oxygen uptake (VO2max)
timeFrame: Week 6, Week 12 and Week 18
measure: Questionnaire of subjective fatigue
timeFrame: Day 0, Week 6, Week 12, Week 18 and Week 24
measure: nuclear magnetic resonance imaging
timeFrame: Inclusion
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Leonard FEASSON, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orebro University, Sweden
name: Fawzi KADI, MD-PhD
role: STUDY_CHAIR
References: