Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: fibromyalgia patients with 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. |
Other: 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), Haute-Loire (43) or Ardèche (07) for 2 months.
|
| Other: fibromyalgia patients with physical activity at home Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). |
Other: 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).
|
Outcome Measures
Primary Outcome Measures
- physical activity [12 months]
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
Secondary Outcome Measures
- sedentary [12 and 24 months]
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
- physical activity [0, 1, 3, 6, 12 and 24 months]
Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph
- sedentary [0, 1, 3, 6, 12 and 24 months]
Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph
- health status [0, 1, 3, 6, 12 and 24 months]
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.
- fatigue [0, 1, 3, 6, 12 and 24 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 [0, 1, 3, 6, 12 and 24 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.
- Anxiety and Depression [0, 1, 3, 6, 12 and 24 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 [0, 1, 3, 6, 12 and 24 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
- pain evaluation [6 and 12 months]
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
- fatigue evaluation [6 and 12 months]
assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)
- muscle power [0, 1 and 3 months]
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
- muscular endurance [0, 1 and 3 months]
evaluated by dynamometry on a stress platform (arms and legs).
- gas exchange measurement [0, 1 and 3 months]
evaluated during a stress test
- fatigue [0, 1 and 3 months]
evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex
- quantification of physical activity in meter-h/week [0, 1, 3, 6,12 and 24 months]
evaluated by the APAQ : Adult Physical Activity Questionnaire
- sedentary times in hours/day [0, 1, 3, 6, 12 and 24 months]
evaluated by the APAQ : Adult Physical Activity Questionnaire
- patient adherence [6 and 12 months]
number of sessions performed
- Direct medical costs [12 months]
consultations, examinations, hospitalizations in euros
- Direct non-medical costs [12 and 24 months]
transport
- Cost of lost productivity [12 and 24 months]
time not worked
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 150 minutes 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH d'ANNONAY | Annonay | France | 07100 | |
| 2 | CH de Firminy | Firminy | France | 42700 | |
| 3 | CH de MONTBRISON | Montbrison | France | 42600 | |
| 4 | CH de Rive de Gier | Rive-de-Gier | France | 42800 | |
| 5 | CH de ROANNE | Roanne | France | 42300 | |
| 6 | CH du Gier | Saint Chamond | France | 42400 | |
| 7 | Chu Saint Etienne | Saint Etienne | France | 42055 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Principal Investigator: David HUPIN, CHU de Saint Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18PH223
- 2019-A02221-56