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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01597-48 | 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.
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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) or Haute-Loire (43) for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David HUPIN, MD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint Etienne | Saint-Etienne | 42055 | France |
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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). |
|
| 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. |
| 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. | 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 | at 3 months |
| pain evaluation | assessed by analog visual evaluation of pain (0= no pain and 10 = very painful) | at 3 months |
| muscle power | evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer. | at 3 months |
| muscular endurance | evaluated by dynamometry on a stress platform (arms and legs). | at 3 months |
| gas exchange measurement | evaluated during a stress test | at 3 months |
| quantification of physical activity in meter-h/week | evaluated by the APAQ : Adult Physical Activity Questionnaire | at 3 months |
| sedentary times in hours/day | evaluated by the APAQ : Adult Physical Activity Questionnaire | at 3 months |
| daily energy expenditure | evaluated by actimetry | at 3 months |
| time of physical activity | evaluated by actimetry | at 3 months |
| physical inactivity | evaluated by actimetry | at 3 months |
| patient adherence | number of sessions performed | at 3, 6 and 12 months |
| Direct medical costs | consultations, examinations, hospitalizations in euros | at 3, 6 and 12 months |
| Direct non-medical costs | transport | at 3, 6 and 12 months |
| Cost of lost productivity | time not worked | at 3, 6 and 12 months |
| 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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