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

Centre Hospitalier Universitaire de Saint Etienne60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Fibromyalgia Physical Activity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: at 3 months

Secondary Outcomes

fatigue

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

Time frame: at 3 months

Quality of sleep

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.

Time frame: at 3 months

Anxiety and Depression

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.

Time frame: at 3 months

pain catastrophizing

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

Time frame: at 3 months

pain evaluation

assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

Time frame: at 3 months

muscle power

evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

Time frame: at 3 months

muscular endurance

evaluated by dynamometry on a stress platform (arms and legs).

Time frame: at 3 months

gas exchange measurement

evaluated during a stress test

Time frame: at 3 months

quantification of physical activity in meter-h/week

evaluated by the APAQ : Adult Physical Activity Questionnaire

Time frame: at 3 months

sedentary times in hours/day

evaluated by the APAQ : Adult Physical Activity Questionnaire

Time frame: at 3 months

daily energy expenditure

evaluated by actimetry

Time frame: at 3 months

time of physical activity

evaluated by actimetry

Time frame: at 3 months

physical inactivity

evaluated by actimetry

Time frame: at 3 months

patient adherence

number of sessions performed

Time frame: at 3, 6 and 12 months

Direct medical costs

consultations, examinations, hospitalizations in euros

Time frame: at 3, 6 and 12 months

Direct non-medical costs

transport

Time frame: at 3, 6 and 12 months

Cost of lost productivity

time not worked

Time frame: at 3, 6 and 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes