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

NCT01689480 | Completed

• 2 other identifiers: 11081532011-A01186-35
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscular Dystrophy, Facioscapulohumeral

Keywords

Muscular Dystrophy; Facioscapulohumeral; Physical training; Exercise

Outcome Measures

Primary Outcomes (1)

• patient's compliance

  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.

  at 24 months

Study Arms (1)

FSHD training

Only the patients who have participated to the FSHD1 study (NCT01116570) can be included in this study.

Other: FSHD training

Interventions

FSHD training OTHER

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.

FSHD training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 study

You may qualify if:

• Included in the FSHD1 study
• Social Security regimen affiliated
• Consent form signed

You may not qualify if:

• Severe cardiac or respiratory insufficiency
• Cardiac pacemaker
• Morbid obesity (BMI upper to 35)
• Anti platelet therapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator

Study Sites (2)

CHU de Grenbole

Grenoble, 38000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral; Muscular Dystrophies; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Léonard FEASSON, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)