Clinical trial NCT03736733: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.
Official title: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Physical Activity
Keywords: sedentary time
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Assessment of the impact of a 3-month program
timeFrame: at 3 months
Secondary outcomes:
measure: fatigue
timeFrame: at 3 months
measure: Quality of sleep
timeFrame: at 3 months
measure: Anxiety and Depression
timeFrame: at 3 months
measure: pain catastrophizing
timeFrame: at 3 months
measure: pain evaluation
timeFrame: at 3 months
measure: muscle power
timeFrame: at 3 months
measure: muscular endurance
timeFrame: at 3 months
measure: gas exchange measurement
timeFrame: at 3 months
measure: quantification of physical activity in meter-h/week
timeFrame: at 3 months
measure: sedentary times in hours/day
timeFrame: at 3 months
measure: daily energy expenditure
timeFrame: at 3 months
measure: time of physical activity
timeFrame: at 3 months
measure: physical inactivity
timeFrame: at 3 months
measure: patient adherence
timeFrame: at 3, 6 and 12 months
measure: Direct medical costs
timeFrame: at 3, 6 and 12 months
measure: Direct non-medical costs
timeFrame: at 3, 6 and 12 months
measure: Cost of lost productivity
timeFrame: at 3, 6 and 12 months
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: