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Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)

28. september 2022 opdateret af: Centre Hospitalier Universitaire de Saint Etienne

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Saint Etienne, Frankrig, 42055
        • Chu Saint Etienne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: fibromyalgipatienter med fysisk aktivitetsprogram
To ugentlige træningssessioner på universitetshospitalet i St-Etienne i 1 måned og derefter stafet udenfor i en sportsforening eller klub certificeret "Sports Health" i Loire (42) eller Haute-Loire (43) i 2 måneder.
Andet: 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.
Andet: fibromyalgipatienter med fysisk aktivitet i hjemmet
Råd og anbefalinger om fysisk aktivitet i hjemmet (= nuværende klinisk praksis, fra 1 til 3 sessioner om ugen i autonomi).
Andet: Råd og anbefalinger om fysisk aktivitet i hjemmet
Råd og anbefalinger om fysisk aktivitet i hjemmet (= nuværende klinisk praksis, fra 1 til 3 sessioner om ugen i autonomi).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of the impact of a 3-month program
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
fatigue
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
at 3 months
pain catastrophizing
Tidsramme: 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
at 3 months
pain evaluation
Tidsramme: at 3 months
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
at 3 months
muscle power
Tidsramme: at 3 months
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
at 3 months
muscular endurance
Tidsramme: at 3 months
evaluated by dynamometry on a stress platform (arms and legs).
at 3 months
gas exchange measurement
Tidsramme: at 3 months
evaluated during a stress test
at 3 months
quantification of physical activity in meter-h/week
Tidsramme: at 3 months
evaluated by the APAQ : Adult Physical Activity Questionnaire
at 3 months
sedentary times in hours/day
Tidsramme: at 3 months
evaluated by the APAQ : Adult Physical Activity Questionnaire
at 3 months
daily energy expenditure
Tidsramme: at 3 months
evaluated by actimetry
at 3 months
time of physical activity
Tidsramme: at 3 months
evaluated by actimetry
at 3 months
physical inactivity
Tidsramme: at 3 months
evaluated by actimetry
at 3 months
patient adherence
Tidsramme: at 3, 6 and 12 months
number of sessions performed
at 3, 6 and 12 months
Direct medical costs
Tidsramme: at 3, 6 and 12 months
consultations, examinations, hospitalizations in euros
at 3, 6 and 12 months
Direct non-medical costs
Tidsramme: at 3, 6 and 12 months
transport
at 3, 6 and 12 months
Cost of lost productivity
Tidsramme: at 3, 6 and 12 months
time not worked
at 3, 6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: David HUPIN, MD, CHU de Saint Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. november 2018

Primær færdiggørelse (Faktiske)

19. december 2019

Studieafslutning (Faktiske)

11. juni 2021

Datoer for studieregistrering

Først indsendt

5. november 2018

Først indsendt, der opfyldte QC-kriterier

8. november 2018

Først opslået (Faktiske)

9. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18CH051
  • 2018-A01597-48 (Anden identifikator: ANSM)

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