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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Muscular Dystrophy, Facioscapulohumeral

Treatments

Other: FSHD training

Study type

Observational

Funder types

Other

Identifiers

NCT01689480
1108153
2011-A01186-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

FSHD training
Description:
Only the patients who have participated to the FSHD1 study (NCT01116570) can be included in this study.
Treatment:
Other: FSHD training

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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