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

May 5, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sedentary
Time Frame: 12 and 24 months
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
Time Frame: 0, 1, 3, 6, 12 and 24 months
Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph
0, 1, 3, 6, 12 and 24 months
sedentary
Time Frame: 0, 1, 3, 6, 12 and 24 months
Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph
0, 1, 3, 6, 12 and 24 months
health status
Time Frame: 0, 1, 3, 6, 12 and 24 months
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
Time Frame: 0, 1, 3, 6, 12 and 24 months

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
Time Frame: 0, 1, 3, 6, 12 and 24 months

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
Time Frame: 0, 1, 3, 6, 12 and 24 months
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
Time Frame: 0, 1, 3, 6, 12 and 24 months
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
Time Frame: 6 and 12 months
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
6 and 12 months
fatigue evaluation
Time Frame: 6 and 12 months
assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)
6 and 12 months
muscle power
Time Frame: 0, 1 and 3 months
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
0, 1 and 3 months
muscular endurance
Time Frame: 0, 1 and 3 months
evaluated by dynamometry on a stress platform (arms and legs).
0, 1 and 3 months
gas exchange measurement
Time Frame: 0, 1 and 3 months
evaluated during a stress test
0, 1 and 3 months
fatigue
Time Frame: 0, 1 and 3 months
evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex
0, 1 and 3 months
quantification of physical activity in meter-h/week
Time Frame: 0, 1, 3, 6,12 and 24 months
evaluated by the APAQ : Adult Physical Activity Questionnaire
0, 1, 3, 6,12 and 24 months
sedentary times in hours/day
Time Frame: 0, 1, 3, 6, 12 and 24 months
evaluated by the APAQ : Adult Physical Activity Questionnaire
0, 1, 3, 6, 12 and 24 months
patient adherence
Time Frame: 6 and 12 months
number of sessions performed
6 and 12 months
Direct medical costs
Time Frame: 12 months
consultations, examinations, hospitalizations in euros
12 months
Direct non-medical costs
Time Frame: 12 and 24 months
transport
12 and 24 months
Cost of lost productivity
Time Frame: 12 and 24 months
time not worked
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David HUPIN, CHU de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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