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FibromyalgiaFIMOUV 2NCT04107948

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

A study testing physical activity program and Advice and recommendations of physical activity at home in people with Fibromyalgia and Physical Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibromyalgia, Physical Activity
What is being tested?
physical activity program and Advice and recommendations of physical activity at home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
7 sitesFrance
Study dates
23 Jan 2020to 1 Oct 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CH d'ANNONAY

    Annonay, 07100

  • CH de Firminy

    Firminy, 42700

  • CH de MONTBRISON

    Montbrison, 42600

  • CH de Rive de Gier

    Rive-de-Gier, 42800

  • CH de ROANNE

    Roanne, 42300

  • CH du Gier

    Saint-Chamond, 42400

  • Chu Saint Etienne

    Saint-Etienne, 42055

Other trials in France

About this 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

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.

Read the 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).
Being tested
physical activity program, Advice and recommendations of physical activity at home
Keywords
sedentary time, therapeutic education sessions
Medical subject headings
Fibromyalgia, Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical activity programOther

    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 homeOther

    Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Study groups in NCT04107948
Study groupRoleWhat they receive
fibromyalgia patients with physical activity programExperimentalTwo 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.
Receives: Other: physical activity program
fibromyalgia patients with physical activity at homeOtherAdvice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Receives: Other: Advice and recommendations of physical activity at home

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (20)

  1. 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

    Measured: 12 and 24 months

  2. physical activity

    Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph

    Measured: 0, 1, 3, 6, 12 and 24 months

  3. sedentary

    Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph

    Measured: 0, 1, 3, 6, 12 and 24 months

  4. 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.

    Measured: 0, 1, 3, 6, 12 and 24 months

  5. 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

    Measured: 0, 1, 3, 6, 12 and 24 months

  6. 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.

    Measured: 0, 1, 3, 6, 12 and 24 months

  7. 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.

    Measured: 0, 1, 3, 6, 12 and 24 months

  8. 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

    Measured: 0, 1, 3, 6, 12 and 24 months

  9. pain evaluation

    assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

    Measured: 6 and 12 months

  10. fatigue evaluation

    assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)

    Measured: 6 and 12 months

  11. muscle power

    evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

    Measured: 0, 1 and 3 months

  12. muscular endurance

    evaluated by dynamometry on a stress platform (arms and legs).

    Measured: 0, 1 and 3 months

  13. gas exchange measurement

    evaluated during a stress test

    Measured: 0, 1 and 3 months

  14. fatigue

    evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex

    Measured: 0, 1 and 3 months

  15. quantification of physical activity in meter-h/week

    evaluated by the APAQ : Adult Physical Activity Questionnaire

    Measured: 0, 1, 3, 6,12 and 24 months

  16. sedentary times in hours/day

    evaluated by the APAQ : Adult Physical Activity Questionnaire

    Measured: 0, 1, 3, 6, 12 and 24 months

  17. patient adherence

    number of sessions performed

    Measured: 6 and 12 months

  18. Direct medical costs

    consultations, examinations, hospitalizations in euros

    Measured: 12 months

  19. Direct non-medical costs

    transport

    Measured: 12 and 24 months

  20. Cost of lost productivity

    time not worked

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start23 Jan 2020
  3. Primary completion1 Oct 2025
  4. Study completion1 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04107948
Sponsor's protocol ID
18PH223
Other IDs
2019-A02221-56
Acronym
FIMOUV 2
Status last verified
May 2026
First submitted
26 Sep 2019
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34354626

  • 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.

    PubMed 34113593

Questions about this trial

What is this clinical trial studying?

A study testing physical activity program and Advice and recommendations of physical activity at home in people with Fibromyalgia and Physical Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

physical activity (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107948, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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