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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Fibromyalgia
• Intervention / Treatment: Other: physical activity program; Other: Advice and recommendations of physical activity at home

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).

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annonay, France, 07100
    • CH d'ANNONAY
  • Firminy, France, 42700
    • CH de Firminy
  • Montbrison, France, 42600
    • CH de MONTBRISON
  • Rive-de-Gier, France, 42800
    • CH de Rive de Gier
  • Roanne, France, 42300
    • CH de ROANNE
  • Saint-Chamond, France, 42400
    • CH du Gier
  • Saint-Etienne, France, 42055
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Other: 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).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedentary	Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph	12 and 24 months
physical activity	Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph	0, 1, 3, 6, 12 and 24 months
sedentary	Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph	0, 1, 3, 6, 12 and 24 months
health status	measured with Patient Global Impression of Change (PGIC) : on a 7-point scale, rated from 1 for "much worse" to 7 for "much better". It is a simple and practical evaluation tool to use. The combination of the level of achievement via the Patient Global Impression of Change and the initial documentation of the patient's objectives via the shared educational assessment is a relevant and understandable approach for the patient.	0, 1, 3, 6, 12 and 24 months
fatigue	assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5	0, 1, 3, 6, 12 and 24 months
Quality of sleep	assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.	0, 1, 3, 6, 12 and 24 months
Anxiety and Depression	assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.	0, 1, 3, 6, 12 and 24 months
pain catastrophizing	assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time	0, 1, 3, 6, 12 and 24 months
pain evaluation	assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)	6 and 12 months
fatigue evaluation	assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)	6 and 12 months
muscle power	evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.	0, 1 and 3 months
muscular endurance	evaluated by dynamometry on a stress platform (arms and legs).	0, 1 and 3 months
gas exchange measurement	evaluated during a stress test	0, 1 and 3 months
fatigue	evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex	0, 1 and 3 months
quantification of physical activity in meter-h/week	evaluated by the APAQ : Adult Physical Activity Questionnaire	0, 1, 3, 6,12 and 24 months
sedentary times in hours/day	evaluated by the APAQ : Adult Physical Activity Questionnaire	0, 1, 3, 6, 12 and 24 months
patient adherence	number of sessions performed	6 and 12 months
Direct medical costs	consultations, examinations, hospitalizations in euros	12 months
Direct non-medical costs	transport	12 and 24 months
Cost of lost productivity	time not worked	12 and 24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, CHU de Saint Étienne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): October 1, 2025
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sedentary time; therapeutic education sessions
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Behavior; Fibromyalgia; Motor Activity; Sedentary Behavior; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: 18PH223; 2019-A02221-56 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No