Clinical trial NCT04107948: Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Physical Activity
Keywords: sedentary time
therapeutic education sessions
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: physical activity
timeFrame: 12 months
Secondary outcomes:
measure: sedentary
timeFrame: 12 and 24 months
measure: physical activity
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: sedentary
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: health status
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: fatigue
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: Quality of sleep
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: Anxiety and Depression
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: pain catastrophizing
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: pain evaluation
timeFrame: 6 and 12 months
measure: fatigue evaluation
timeFrame: 6 and 12 months
measure: muscle power
timeFrame: 0, 1 and 3 months
measure: muscular endurance
timeFrame: 0, 1 and 3 months
measure: gas exchange measurement
timeFrame: 0, 1 and 3 months
measure: fatigue
timeFrame: 0, 1 and 3 months
measure: quantification of physical activity in meter-h/week
timeFrame: 0, 1, 3, 6,12 and 24 months
measure: sedentary times in hours/day
timeFrame: 0, 1, 3, 6, 12 and 24 months
measure: patient adherence
timeFrame: 6 and 12 months
measure: Direct medical costs
timeFrame: 12 months
measure: Direct non-medical costs
timeFrame: 12 and 24 months
measure: Cost of lost productivity
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Annonay
country: France
facility: CH d'ANNONAY
city: Firminy
country: France
facility: CH de Firminy
city: Montbrison
country: France
facility: CH de MONTBRISON
city: Rive-de-Gier
country: France
facility: CH de Rive de Gier
city: Roanne
country: France
facility: CH de ROANNE
city: Saint Chamond
country: France
facility: CH du Gier
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: David HUPIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colas C, Jumel A, Vericel MP, Barth N, Manzanares J, Goutte J, Fontana L, Feasson L, Hupin D, Guyot J. Understanding Experiences of Fibromyalgia Patients Involved in the Fimouv Study During COVID-19 Lockdown. Front Psychol. 2021 Jul 20;12:645092. doi: 10.3389/fpsyg.2021.645092. eCollection 2021.
citation: Colas C, Goutte J, Creac'h C, Fontana L, Vericel MP, Manzanares J, Peuriere M, Akrour M, Martin C, Presles E, Barth N, Guyot J, Garros M, Trombert B, Massoubre C, Roche F, Feasson L, Marotte H, Cathebras P, Hupin D. Efficiency of an Optimized Care Organization in Fibromyalgia Patients: The From Intent to Move (FIMOUV) Study Protocol of a Randomized Controlled Trial. Front Public Health. 2021 May 25;9:554291. doi: 10.3389/fpubh.2021.554291. eCollection 2021.