Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study
NCT ID: NCT04107948
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
330 participants
INTERVENTIONAL
2020-01-23
2031-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
fibromyalgia patients with physical activity program
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.
physical activity program
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.
fibromyalgia patients with physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Advice and recommendations of physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
physical activity program
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.
Advice and recommendations of physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David HUPIN
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CH d'ANNONAY
Annonay, , France
CH de Firminy
Firminy, , France
CH de MONTBRISON
Montbrison, , France
CH de Rive de Gier
Rive-de-Gier, , France
CH de ROANNE
Roanne, , France
CH du Gier
Saint-Chamond, , France
Chu Saint Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
HUPIN David
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A02221-56
Identifier Type: OTHER
Identifier Source: secondary_id
18PH223
Identifier Type: -
Identifier Source: org_study_id