Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.

NCT ID: NCT03736733

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2021-06-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

physical activity program

Intervention Type: OTHER

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.

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).

Group Type: OTHER

Advice and recommendations of physical activity at home

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient lived in t Loire (42) or Haute-Loire (43)
• 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 2 hours 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-A01597-48

Identifier Type: OTHER

Identifier Source: secondary_id

18CH051

Identifier Type: -

Identifier Source: org_study_id