Trial record 10 of 15 for:    "facioscapulohumeral muscular dystrophy"

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

This study is currently recruiting participants.
Verified October 2013 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Association Française contre les Myopathies (AFM), Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01689480
First received: September 18, 2012
Last updated: October 24, 2013
Last verified: October 2013
  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 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 Intervention
Muscular Dystrophy, Facioscapulohumeral
Other: FSHD training

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • patient's compliance [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01689480

Contacts
Contact: Léonard FEASSON, MD PhD (0)477127985 ext +33 leonard.feasson@chu-st-etienne.fr
Contact: Karine FERRAUD, CRA (0)477127985 ext +33 karine.ferraud@univ-st-etienne.fr

Locations
France
CHU de Grenbole Recruiting
Grenoble, France, 38000
Principal Investigator: Bernard WUYAM, MD         
Sub-Investigator: Emmeline LAGRANGE, MD         
Sub-Investigator: Célia BOUTTE, MD         
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42000
Principal Investigator: Léonard FEASSON, MD PhD         
Sub-Investigator: Jean-Christophe ANTOINE, MD PhD         
Sub-Investigator: Pascal EDOUARD, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association Française contre les Myopathies (AFM), Paris
Investigators
Principal Investigator: Léonard FEASSON, MD PhD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01689480     History of Changes
Other Study ID Numbers: 1108153, 2011-A01186-35
Study First Received: September 18, 2012
Last Updated: October 24, 2013
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 22, 2014