Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.
- Conditions
- Physical ActivityFibromyalgia
- Interventions
- Other: physical activity programOther: Advice and recommendations of physical activity at home
- Registration Number
- NCT03736733
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Arm && Interventions
Group Intervention Description fibromyalgia patients with physical activity program 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. fibromyalgia patients with physical activity at home 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).
- 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 5.5Quality 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)
daily energy expenditure at 3 months evaluated by actimetry
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
Trial Locations
- Locations (1)
Chu Saint Etienne
🇫🇷Saint Etienne, France