Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients

NCT01116570 | Completed

• 3 other identifiers: 10010352010-A00288-312009.1087-14263
• Study Type: interventional
• 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 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.

Conditions

Muscular Dystrophy, Facioscapulohumeral

Keywords

Muscular Dystrophy; Facioscapulohumeral; Physical training; Exercise

Outcome Measures

Primary Outcomes (1)

• maximal oxygen uptake (VO2max)

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

  Week 24

Secondary Outcomes (5)

• Questionnaire of quality of life

  Day 0, Week 6, Week 12, Week 18 and Week 24

• Biopsy

  Day 0 and Week 24

• maximal oxygen uptake (VO2max)

  Week 6, Week 12 and Week 18

• Questionnaire of subjective fatigue

  Day 0, Week 6, Week 12, Week 18 and Week 24

• nuclear magnetic resonance imaging

  Inclusion

Study Arms (2)

Physical training

EXPERIMENTAL

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

control

OTHER

None intervention

Other: Control

Interventions

Physical training OTHER

Physical training during 24 weeks

Physical training

Control OTHER

No intervention

control

Eligibility Criteria

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

You may qualify if:

• facioscapulohumeral dystrophy
• Being capable of supporting an exercise on ergocycle
• 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
• Örebro University, Sweden: collaborator

Study Sites (2)

CHU de Grenoble

Grenoble, 38000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Muscular Dystrophy, Facioscapulohumeral; Muscular Dystrophies; Motor Activity

Interventions

Physical Conditioning, Human

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

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leonard FEASSON, MD-PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

• Fawzi KADI, MD-PhD

  Orebro University, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 5, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

FR (2)