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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Saint Etienne, Frankrijk, 42055
- CHU Saint Etienne
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: fibromyalgiepatiënten met een programma voor lichaamsbeweging
Twee wekelijkse oefensessies in het academisch ziekenhuis van St-Etienne gedurende 1 maand, daarna estafette buiten in een sportvereniging of club gecertificeerd "Sports Health" in de Loire (42) of Haute-Loire (43) gedurende 2 maanden.
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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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Ander: fibromyalgiepatiënten met fysieke activiteit thuis
Advies en aanbevelingen voor fysieke activiteit thuis (= huidige klinische praktijk, van 1 tot 3 sessies per week in autonomie).
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Advies en aanbevelingen voor fysieke activiteit thuis (= huidige klinische praktijk, van 1 tot 3 sessies per week in autonomie).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Assessment of the impact of a 3-month program
Tijdsspanne: at 3 months
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Health status assessed by the PGIC = Patient Global Impression of Change.
interpretation : 0= no change, 7= clear improvement, 5= better).
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at 3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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fatigue
Tijdsspanne: at 3 months
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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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Quality of sleep
Tijdsspanne: at 3 months
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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
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Anxiety and Depression
Tijdsspanne: at 3 months
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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
Tijdsspanne: at 3 months
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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
Tijdsspanne: at 3 months
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assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
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at 3 months
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muscle power
Tijdsspanne: at 3 months
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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
Tijdsspanne: at 3 months
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evaluated by dynamometry on a stress platform (arms and legs).
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at 3 months
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gas exchange measurement
Tijdsspanne: 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
Tijdsspanne: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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sedentary times in hours/day
Tijdsspanne: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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daily energy expenditure
Tijdsspanne: at 3 months
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evaluated by actimetry
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at 3 months
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time of physical activity
Tijdsspanne: at 3 months
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evaluated by actimetry
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at 3 months
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physical inactivity
Tijdsspanne: at 3 months
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evaluated by actimetry
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at 3 months
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patient adherence
Tijdsspanne: 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
Tijdsspanne: at 3, 6 and 12 months
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consultations, examinations, hospitalizations in euros
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at 3, 6 and 12 months
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Direct non-medical costs
Tijdsspanne: at 3, 6 and 12 months
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transport
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at 3, 6 and 12 months
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Cost of lost productivity
Tijdsspanne: at 3, 6 and 12 months
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time not worked
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at 3, 6 and 12 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: David HUPIN, MD, CHU de Saint Etienne
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 18CH051
- 2018-A01597-48 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
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