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Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With FSHD : Tolerance, Sustainability and Efficiency of Unsupervised Training Program. (FSHD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01689480
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : December 9, 2015
Association Française contre les Myopathies (AFM), Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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 with physiological and functional positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et al. (2007) studies suggest that the combination of endurance and strength trainings is even more relevant. However, only a few controlled and randomized studies have been conducted on this topic and the impact of such training programs on skeletal muscle regenerative capacities has not been addressed yet. 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 practice of regular exercise can be maintained in patient's daily life. Also, only a few experiments report an integrative view of potential benefits of such programs on functional, biological and quality of life.

Condition or disease Intervention/treatment
Muscular Dystrophy, Facioscapulohumeral Other: FSHD training

Detailed Description:

The present project is the second phase of a study for which the first phase currently financed by AFM is in progress and aims to establish a program of adapted physical training performed at the patient's home under supervision. This program was developed in order to try to meet the two following requirements: 1) to be compatible with the daily professional/social activity of patients so it can be integrated in their life routine; 2) to be intense enough so functional benefits can be induced. The first phase is a controlled and randomized study where patients with FSHD participate in a 6-months supervised training program combining aerobic and strength training sessions on an ergocycle.

This second phase of our research project aims to evaluate whether a long-term integration of this adapted training program into patients' lifestyle is possible. The same tools, same method and same measurements of training program will be used with remote monitoring, less frequent as it was in the first phase, over a period of 24 months. This second experimental work will also be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires and remains collaboration between 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).

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With Facioscapulohumeral Dystrophy : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.
Study Start Date : December 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Group/Cohort Intervention/treatment
FSHD training
Only the patients who have participated to the FSHD1 study (NCT01116570) can be included in this study.
Other: FSHD training
The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. 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. 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.

Primary Outcome Measures :
  1. patient's compliance [ Time Frame: at 24 months ]
    Number of adapted physical activity sessions conducted over 2 years in patients with FSHD based on a theoretical program of three weekly sessions. A session will be considered valid based on the collection 1) time physical activity actually performed and 2) its intensity, both recorded from the cycle ergometer and a heart rate record.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 study

Inclusion Criteria:

  • Included in the FSHD1 study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01689480

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CHU de Grenbole
Grenoble, France, 38000
CHU de Saint-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association Française contre les Myopathies (AFM), Paris
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Principal Investigator: Léonard FEASSON, MD PhD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT01689480     History of Changes
Other Study ID Numbers: 1108153
2011-A01186-35 ( Other Identifier: AFSSAPS )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Muscular Dystrophy
Physical training
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn