Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients

NCT ID: NCT01116570

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-01-31

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.

Conditions

Muscular Dystrophy, Facioscapulohumeral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical training

The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. As a result, lower limb muscles will be mainly solicited. These muscles are heterogeneous in terms of deficiency, but this latter is compatible with cycling. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. Over a 2 to 4 weeks initial period, the program will be conducted in the laboratory or at home under the supervision of a coach. Then a systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue.

Group Type: EXPERIMENTAL

Physical training

Intervention Type: OTHER

Physical training during 24 weeks

control

None intervention

Group Type: OTHER

Control

Intervention Type: OTHER

No intervention

Interventions

Physical training

Physical training during 24 weeks

Intervention Type: OTHER

Control

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Française contre les Myopathies (AFM), Paris

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard FEASSON, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Fawzi KADI, MD-PhD

Role: STUDY_CHAIR

Orebro University, Sweden

Locations

CHU de Grenoble

Grenoble, , France

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2010-A00288-31

Identifier Type: OTHER

Identifier Source: secondary_id

2009.1087-14263

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1001035

Identifier Type: -

Identifier Source: org_study_id