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Completed

NCT Number: NCT01116570

Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients

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.

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Key information

Conditions

Muscular Dystrophy, Facioscapulohumeral Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical training

Other

Physical training during 24 weeks

Control

Other

No intervention

Primary outcomes

  1. maximal oxygen uptake (VO2max)

    Time frame: Week 24

    VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle

Secondary outcomes

  1. Questionnaire of quality of life

    Time frame: Day 0, Week 6, Week 12, Week 18 and Week 24

    "short form 36 health survey questionnaire" SF36

  2. Biopsy

    Time frame: Day 0 and Week 24

    biopsy of the vastus lateralis muscle

  3. maximal oxygen uptake (VO2max)

    Time frame: Week 6, Week 12 and Week 18

    VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle

  4. Questionnaire of subjective fatigue

    Time frame: Day 0, Week 6, Week 12, Week 18 and Week 24

    Fatigue severity scale (FSS)

  5. nuclear magnetic resonance imaging

    Time frame: Inclusion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris
  • Örebro University, Sweden

Registry information

Official study title

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

Acronym: FSHD1

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 5, 2010
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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