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.
In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining: * an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town) * therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
330
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), Haute-Loire (43) or Ardèche (07) for 2 months.
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
CH d'ANNONAY
Annonay, France
RECRUITINGCH de Firminy
Firminy, France
RECRUITINGCH de MONTBRISON
Montbrison, France
RECRUITINGCH de Rive de Gier
Rive-de-Gier, France
NOT_YET_RECRUITINGCH de ROANNE
Roanne, France
RECRUITINGCH du Gier
Saint-Chamond, France
RECRUITINGChu Saint Etienne
Saint-Etienne, France
RECRUITINGphysical activity
Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph
Time frame: 12 months
sedentary
Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph
Time frame: 12 and 24 months
physical activity
Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph
Time frame: 0, 1, 3, 6, 12 and 24 months
sedentary
Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph
Time frame: 0, 1, 3, 6, 12 and 24 months
health status
measured with Patient Global Impression of Change (PGIC) : on a 7-point scale, rated from 1 for "much worse" to 7 for "much better". It is a simple and practical evaluation tool to use. The combination of the level of achievement via the Patient Global Impression of Change and the initial documentation of the patient's objectives via the shared educational assessment is a relevant and understandable approach for the patient.
Time frame: 0, 1, 3, 6, 12 and 24 months
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: 0, 1, 3, 6, 12 and 24 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: 0, 1, 3, 6, 12 and 24 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: 0, 1, 3, 6, 12 and 24 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: 0, 1, 3, 6, 12 and 24 months
pain evaluation
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
Time frame: 6 and 12 months
fatigue evaluation
assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)
Time frame: 6 and 12 months
muscle power
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
Time frame: 0, 1 and 3 months
muscular endurance
evaluated by dynamometry on a stress platform (arms and legs).
Time frame: 0, 1 and 3 months
gas exchange measurement
evaluated during a stress test
Time frame: 0, 1 and 3 months
fatigue
evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex
Time frame: 0, 1 and 3 months
quantification of physical activity in meter-h/week
evaluated by the APAQ : Adult Physical Activity Questionnaire
Time frame: 0, 1, 3, 6,12 and 24 months
sedentary times in hours/day
evaluated by the APAQ : Adult Physical Activity Questionnaire
Time frame: 0, 1, 3, 6, 12 and 24 months
patient adherence
number of sessions performed
Time frame: 6 and 12 months
Direct medical costs
consultations, examinations, hospitalizations in euros
Time frame: 12 months
Direct non-medical costs
transport
Time frame: 12 and 24 months
Cost of lost productivity
time not worked
Time frame: 12 and 24 months
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