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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Fibromyalgia; Physical Activity

Treatments: Other: Advice and recommendations of physical activity at home; Other: physical activity program

Study type: Interventional

Funder types: Other

Identifiers

NCT04107948

18PH223

2019-A02221-56 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

fibromyalgia patients with physical activity program

Experimental group

Description:

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.

Treatment:

Other: physical activity program

fibromyalgia patients with physical activity at home

Other group

Description:

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Treatment:

Other: Advice and recommendations of physical activity at home