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

NCT04107948 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Physical Activity

Interventions

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

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).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • David HUPIN · CHU de Saint Etienne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-23
Primary Completion
2025-10-01
Completion
2031-10-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107948 on ClinicalTrials.gov