Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With FSHD : Tolerance, Sustainability and Efficiency of Unsupervised Training Program. (FSHD2)
|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.|
- 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.
|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)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01689480
|CHU de Grenbole|
|Grenoble, France, 38000|
|CHU de Saint-Etienne|
|Saint-etienne, France, 42000|
|Principal Investigator:||Léonard FEASSON, MD PhD||CHU de Saint-Etienne|