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

Not Applicable

Completed

• Conditions: Physical Activity; Fibromyalgia

• Registration Number: NCT03736733
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2018-11-15
• Primary Completion: 2019-12-19
• Study Completion: 2021-06-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of the impact of a 3-month program	at 3 months	Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).

Secondary Outcome Measures

Name	Time	Method
gas exchange measurement	at 3 months	evaluated during a stress test
time of physical activity	at 3 months	evaluated by actimetry
physical inactivity	at 3 months	evaluated by actimetry
muscular endurance	at 3 months	evaluated by dynamometry on a stress platform (arms and legs).
Direct medical costs	at 3, 6 and 12 months	consultations, examinations, hospitalizations in euros
sedentary times in hours/day	at 3 months	evaluated by the APAQ : Adult Physical Activity Questionnaire
patient adherence	at 3, 6 and 12 months	number of sessions performed
Direct non-medical costs	at 3, 6 and 12 months	transport
fatigue	at 3 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
Quality of sleep	at 3 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.
pain evaluation	at 3 months	assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
Anxiety and Depression	at 3 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.
pain catastrophizing	at 3 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
muscle power	at 3 months	evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
quantification of physical activity in meter-h/week	at 3 months	evaluated by the APAQ : Adult Physical Activity Questionnaire
Cost of lost productivity	at 3, 6 and 12 months	time not worked
daily energy expenditure	at 3 months	evaluated by actimetry

Trial Locations

Locations (1)

Chu Saint Etienne; 🇫🇷 Saint Etienne, France