Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study
FIMOUV 2
2 other identifiers
interventional
330
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
ExpectedMay 6, 2026
May 1, 2026
5.7 years
September 26, 2019
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
physical activity
Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph
12 months
Secondary Outcomes (20)
sedentary
12 and 24 months
physical activity
0, 1, 3, 6, 12 and 24 months
sedentary
0, 1, 3, 6, 12 and 24 months
health status
0, 1, 3, 6, 12 and 24 months
fatigue
0, 1, 3, 6, 12 and 24 months
- +15 more secondary outcomes
Study Arms (2)
fibromyalgia patients with physical activity program
EXPERIMENTALTwo 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.
fibromyalgia patients with physical activity at home
OTHERAdvice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Interventions
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
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), Haute-Loire (43) or Ardèche (07) for 2 months.
Eligibility Criteria
You may qualify if:
- 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
- Signature of informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CH d'ANNONAY
Annonay, 07100, France
CH de Firminy
Firminy, 42700, France
CH de MONTBRISON
Montbrison, 42600, France
CH de Rive de Gier
Rive-de-Gier, 42800, France
CH de ROANNE
Roanne, 42300, France
CH du Gier
Saint-Chamond, 42400, France
Chu Saint Etienne
Saint-Etienne, 42055, France
Related Publications (2)
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.
PMID: 34354626DERIVEDColas 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.
PMID: 34113593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David HUPIN
CHU de Saint Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2019
First Posted
September 27, 2019
Study Start
January 23, 2020
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2031
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share