Informations générales (source: ClinicalTrials.gov)

NCT04107948 En recrutement
Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary (FIMOUV 2)
Interventional
  • Fibromyalgie
  • Syndromes de la douleur myofasciale
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
janvier 2020
octobre 2031
05 avril 2025
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH d'ANNONAY - 07100 - Annonay - France En recrutement Contact (sur clinicalTrials)
CH de Firminy - 42700 - Firminy - France En recrutement Contact (sur clinicalTrials)
CH de MONTBRISON - 42600 - Montbrison - France En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH de Rive de Gier - 42800 - Rive-de-Gier - France Recrutement non commencé Contact (sur clinicalTrials)
CH de ROANNE - 42300 - Roanne - France En recrutement Contact (sur clinicalTrials)
CH du Gier - 42400 - Saint Chamond - France En recrutement Contact (sur clinicalTrials)
Chu Saint Etienne - 42055 - Saint Etienne - France HUPIN David En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Patient diagnosed with fibromyalgia according to ACR (American College of
rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity
Scale) ) ≥ 13

- French writing and speaking

- Sedentary or low level of activity (less than 150 minutes of regular physical
activity per week at the time of inclusion)

- Signature of informed consent



- Cardiac or respiratory diseases that contraindicate the practice of physical
activity

- Significant co-morbidities that contraindicate the practice of physical activity:
associated cardiac pathologies (severe rhythm disorders such as rapid atrial
fibrillation), respiratory pathologies (severe obstructive or severe respiratory
insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis
of the hip) training on a treadmill or on a high intensity bike).

- Impossibility of submitting to the medical monitoring of the program for
geographical, social or psychological reason