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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02221-56 | Other Identifier | ANSM |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fibromyalgia patients with physical activity program | Experimental | 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 | Other | Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| physical 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 months |
| physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David HUPIN | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'ANNONAY | Annonay | 07100 | France | |||
| CH de Firminy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34354626 | Derived | Colas C, Jumel A, Vericel MP, Barth N, Manzanares J, Goutte J, Fontana L, Feasson L, Hupin D, Guyot J. Understanding Experiences of Fibromyalgia Patients Involved in the Fimouv Study During COVID-19 Lockdown. Front Psychol. 2021 Jul 20;12:645092. doi: 10.3389/fpsyg.2021.645092. eCollection 2021. | |
| 34113593 | Derived |
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| Advice and recommendations of physical activity at home | Other | Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). |
|
Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph
| 0, 1, 3, 6, 12 and 24 months |
| sedentary | Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph | 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. | 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 | 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. | 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. | 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 | 0, 1, 3, 6, 12 and 24 months |
| pain evaluation | assessed by analog visual evaluation of pain (0= no pain and 10 = very painful) | 6 and 12 months |
| fatigue evaluation | assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue) | 6 and 12 months |
| muscle power | evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer. | 0, 1 and 3 months |
| muscular endurance | evaluated by dynamometry on a stress platform (arms and legs). | 0, 1 and 3 months |
| gas exchange measurement | evaluated during a stress test | 0, 1 and 3 months |
| fatigue | evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex | 0, 1 and 3 months |
| quantification of physical activity in meter-h/week | evaluated by the APAQ : Adult Physical Activity Questionnaire | 0, 1, 3, 6,12 and 24 months |
| sedentary times in hours/day | evaluated by the APAQ : Adult Physical Activity Questionnaire | 0, 1, 3, 6, 12 and 24 months |
| patient adherence | number of sessions performed | 6 and 12 months |
| Direct medical costs | consultations, examinations, hospitalizations in euros | 12 months |
| Direct non-medical costs | transport | 12 and 24 months |
| Cost of lost productivity | time not worked | 12 and 24 months |
| Firminy |
| 42700 |
| France |
| CH de MONTBRISON | Montbrison | 42600 | France |
| CH de Rive de Gier | Rive-de-Gier | 42800 | France |
| CH de ROANNE | Roanne | 42300 | France |
| CH du Gier | Saint-Chamond | 42400 | France |
| Chu Saint Etienne | Saint-Etienne | 42055 | France |
| Colas C, Goutte J, Creac'h C, Fontana L, Vericel MP, Manzanares J, Peuriere M, Akrour M, Martin C, Presles E, Barth N, Guyot J, Garros M, Trombert B, Massoubre C, Roche F, Feasson L, Marotte H, Cathebras P, Hupin D. Efficiency of an Optimized Care Organization in Fibromyalgia Patients: The From Intent to Move (FIMOUV) Study Protocol of a Randomized Controlled Trial. Front Public Health. 2021 May 25;9:554291. doi: 10.3389/fpubh.2021.554291. eCollection 2021. |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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