Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients

Muscular Dystrophy, Facioscapulohumeral Clinical Trial

— FSHD1  

Official title:

Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116570
• Other study ID #: 1001035
• Secondary ID: 2010-A00288-3120
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: March 31, 2015
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: March 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: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

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

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Other:
• Physical training
Physical training during 24 weeks
• Control
No intervention

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Association Française contre les Myopathies (AFM), Paris, Örebro University, Sweden

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal oxygen uptake (VO2max)	VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle	Week 24	No
Secondary	Questionnaire of quality of life	"short form 36 health survey questionnaire" SF36	Day 0, Week 6, Week 12, Week 18 and Week 24	No
Secondary	Biopsy	biopsy of the vastus lateralis muscle	Day 0 and Week 24	No
Secondary	maximal oxygen uptake (VO2max)	VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle	Week 6, Week 12 and Week 18	No
Secondary	Questionnaire of subjective fatigue	Fatigue severity scale (FSS)	Day 0, Week 6, Week 12, Week 18 and Week 24	No
Secondary	nuclear magnetic resonance imaging	In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.	Inclusion	No