Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Saint Etienne, France, 42055
- Chu Saint Etienne
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: patients fibromyalgiques avec programme d'activité physique
Deux séances d'exercices hebdomadaires au CHU de St-Etienne pendant 1 mois puis relais en extérieur dans une association ou club sportif labellisé "Sport Santé" dans la Loire (42) ou la Haute-Loire (43) pendant 2 mois.
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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.
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Autre: patients fibromyalgiques pratiquant une activité physique à domicile
Conseils et recommandations d'activité physique à domicile (= pratique clinique actuelle, de 1 à 3 séances par semaine en autonomie).
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Conseils et recommandations d'activité physique à domicile (= pratique clinique actuelle, de 1 à 3 séances par semaine en autonomie).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessment of the impact of a 3-month program
Délai: at 3 months
|
Health status assessed by the PGIC = Patient Global Impression of Change.
interpretation : 0= no change, 7= clear improvement, 5= better).
|
at 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
fatigue
Délai: 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 5.5 |
at 3 months
|
|
Quality of sleep
Délai: 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. |
at 3 months
|
|
Anxiety and Depression
Délai: 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.
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at 3 months
|
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pain catastrophizing
Délai: 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
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at 3 months
|
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pain evaluation
Délai: at 3 months
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assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
|
at 3 months
|
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muscle power
Délai: at 3 months
|
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
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at 3 months
|
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muscular endurance
Délai: at 3 months
|
evaluated by dynamometry on a stress platform (arms and legs).
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at 3 months
|
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gas exchange measurement
Délai: at 3 months
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evaluated during a stress test
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at 3 months
|
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quantification of physical activity in meter-h/week
Délai: at 3 months
|
evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
|
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sedentary times in hours/day
Délai: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
|
at 3 months
|
|
daily energy expenditure
Délai: at 3 months
|
evaluated by actimetry
|
at 3 months
|
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time of physical activity
Délai: at 3 months
|
evaluated by actimetry
|
at 3 months
|
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physical inactivity
Délai: at 3 months
|
evaluated by actimetry
|
at 3 months
|
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patient adherence
Délai: at 3, 6 and 12 months
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number of sessions performed
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at 3, 6 and 12 months
|
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Direct medical costs
Délai: at 3, 6 and 12 months
|
consultations, examinations, hospitalizations in euros
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at 3, 6 and 12 months
|
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Direct non-medical costs
Délai: at 3, 6 and 12 months
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transport
|
at 3, 6 and 12 months
|
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Cost of lost productivity
Délai: at 3, 6 and 12 months
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time not worked
|
at 3, 6 and 12 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: David HUPIN, MD, CHU de Saint Etienne
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18CH051
- 2018-A01597-48 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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