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

NCT03736733 | Completed

• 2 other identifiers: 18CH0512018-A01597-48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

sedentary time

Outcome Measures

Primary Outcomes (1)

• Assessment of the impact of a 3-month program

  Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).

  at 3 months

Secondary Outcomes (17)

• fatigue

  at 3 months

• Quality of sleep

  at 3 months

• Anxiety and Depression

  at 3 months

• pain catastrophizing

  at 3 months

• pain evaluation

  at 3 months

Study Arms (2)

fibromyalgia patients with physical activity program

EXPERIMENTAL

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

fibromyalgia patients with physical activity at home

OTHER

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

Interventions

physical activity program 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 program

Advice and recommendations of physical activity at home OTHER

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

fibromyalgia patients with physical activity at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Sedentary Behavior

Interventions

Counseling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David HUPIN, MD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 9, 2018
• Study Start: November 15, 2018
• Primary Completion: December 19, 2019
• Study Completion: June 11, 2021
• Last Updated: September 29, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)