Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Last updated: December 16, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Diabetes Prevention

Treatment

Advice and recommendations of physical activity at home

physical activity program

Clinical Study ID

NCT04107948
18PH223
2019-A02221-56
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient diagnosed with fibromyalgia according to ACR (American College ofrheumatology) criteria (total score WPI (Widespread Pain Index) + SS (SeverityScale) ) ≥ 13

  • French writing and speaking

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

  • Signature of informed consent

Exclusion

Exclusion Criteria:

  • Cardiac or respiratory diseases that contraindicate the practice of physicalactivity

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

  • Impossibility of submitting to the medical monitoring of the program forgeographical, social or psychological reason

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Advice and recommendations of physical activity at home
Phase:
Study Start date:
January 23, 2020
Estimated Completion Date:
October 01, 2031

Study Description

In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining:

  • an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town)

  • therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).

Connect with a study center

  • CH d'ANNONAY

    Annonay, 07100
    France

    Active - Recruiting

  • CH de Firminy

    Firminy, 42700
    France

    Active - Recruiting

  • CH de MONTBRISON

    Montbrison, 42600
    France

    Active - Recruiting

  • CH de Rive de Gier

    Rive-de-Gier, 42800
    France

    Site Not Available

  • CH de ROANNE

    Roanne, 42300
    France

    Active - Recruiting

  • CH du Gier

    Saint Chamond, 42400
    France

    Active - Recruiting

  • Chu Saint Etienne

    Saint Etienne, 42055
    France

    Active - Recruiting

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