Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients (FSHD1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Association Française contre les Myopathies (AFM), Paris
Örebro University, Sweden
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01116570
First received: April 28, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Muscular Dystrophy, Facioscapulohumeral
Other: Physical training
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • maximal oxygen uptake (VO2max) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle


Secondary Outcome Measures:
  • Questionnaire of quality of life [ Time Frame: Day 0, Week 6, Week 12, Week 18 and Week 24 ] [ Designated as safety issue: No ]
    "short form 36 health survey questionnaire" SF36

  • Biopsy [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    biopsy of the vastus lateralis muscle

  • maximal oxygen uptake (VO2max) [ Time Frame: Week 6, Week 12 and Week 18 ] [ Designated as safety issue: No ]
    VO2max is meseasured directly by respiratory gas analysis during maximal exercise test on ergocycle

  • Questionnaire of subjective fatigue [ Time Frame: Day 0, Week 6, Week 12, Week 18 and Week 24 ] [ Designated as safety issue: No ]
    Fatigue severity scale (FSS)

  • nuclear magnetic resonance imaging [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
    In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.


Enrollment: 15
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Physical training
Physical training during 24 weeks
control
None intervention
Other: Control
No intervention

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116570

Locations
France
CHU de Grenoble
Grenoble, France, 38000
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association Française contre les Myopathies (AFM), Paris
Örebro University, Sweden
Investigators
Principal Investigator: Leonard FEASSON, MD-PhD CHU de Saint-Etienne
Study Chair: Fawzi KADI, MD-PhD Orebro University, Sweden
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01116570     History of Changes
Other Study ID Numbers: 1001035, 2010-A00288-31, 2009.1087-14263
Study First Received: April 28, 2010
Last Updated: February 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Muscular Dystrophy
Facioscapulohumeral
Physical training
Exercise

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 16, 2014