Effektiviteten av en intervensjon som kombinerer tilpasset fysisk aktivitet og terapeutisk opplæring hos pasienter med kroniske symptomer tilskrevet Lyme borreliose. (LyMouv')
Effektiviteten av en intervensjon som kombinerer tilpasset fysisk aktivitet og terapeutisk opplæring hos pasienter med kroniske symptomer tilskrevet Lyme borreliose. Multisenter, kontrollert, randomisert pilotstudie
Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Apart from the early localized presentation, with a well established treatment, Lyme borreliosis is a complex infection. Indeed, its presentation can be late and very polymorphic, which can evoke functional somatic disorders and make its management difficult. In 2016, the French Ministry of Health decided to launch a national plan to fight Lyme borreliosis. One of the objectives of this national plan was to improve management based on a specific multidisciplinary care pathway.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: David HUPIN, MD
- Telefonnummer: +33 0477828413
- E-post: David.Hupin@chu-st-etienne.fr
Studer Kontakt Backup
- Navn: Elisabeth BOTELHO-NEVERS, MD-PhD
- Telefonnummer: +33 0477120762
- E-post: elisabeth.botelho-nevers@chu-st-etienne.fr
Studiesteder
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Clermont-Ferrand, Frankrike, 63000
- Har ikke rekruttert ennå
- CHU Clermont-Ferrand
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Hovedetterforsker:
- Clémence RICHAUD, MD
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Underetterforsker:
- Clément THEIS, MD
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Saint-Etienne, Frankrike, 42055
- Rekruttering
- Chu Saint Etienne
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Underetterforsker:
- BOTELHO-NEVERS Élisabeth, PhD
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Underetterforsker:
- CAZORLA Céline, MD
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Hovedetterforsker:
- David HUPIN, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient referred to the reference center for tick-borne diseases by his attending physician
- Duration of symptoms >6 months
- At the end of the initial assessment, the diagnosis of functional somatic disorders is retained after consensus between the physicians
- Patient practicing less than 150 minutes of regular physical activity per week (WHO recommendations)
Exclusion Criteria:
- Patients with cardiac or respiratory pathologies that contraindicate the practice of physical activity physical activity
- Important comorbidities contraindicating the practice of physical activity: associated cardiac pathologies associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies respiratory pathologies (obstructive or severe restrictive respiratory insufficiency), disabling joint pathologies joint pathologies (gonarthrosis or coxarthrosis limiting training on a treadmill or on a high-intensity bicycle). intensity cycling).
- Patients under guardianship or curatorship
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Lyme Borreliosis with physical activity program
Referral of the patient to the sport-health center of his department by the investigating physician (in connection with the attending physician for the prescription of Adaptive Physical Activity): for 24 sessions of APA for 3 months at a rate of 2 sessions/week at the sport and health center + 9 sessions of Therapeutic Patient Education in telecare |
24 face-to-face APA sessions at the sport and health center for 3 months at a rate of 2 sessions per week near his home and 9 therapeutic patient education workshops for 3 months at a rate of 3 workshops per month (telecare). |
|
Annen: Lyme Borreliosis patients with physical activity at home
routine clinical practice : encouragement by the attending physician to modify lifestyle habits with advice on resuming regular physical activity independently and combating sedentariness. At home, in autonomy for 3 months. |
Advice and recommendations of physical activity at home (= current clinical practice in autonomy for 3 months). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Average level of moderate to vigorous physical activity (PA) - MET-h/week
Tidsramme: 1 year after implementation of the PA program
|
MET = metabolic equivalent This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). |
1 year after implementation of the PA program
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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average level of sedentary lifestyle (h/day)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
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This is measured with actimetry (Actigraph GT3x, Pensacola, Florida, USA). The average sedentary time measured in industrialized countries is about 4 hours per day (excluding time spent sitting at work and in transport) |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
|
Average level of moderate to vigorous physical activity (PA) - MET-h/week
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
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Average level of sedentary lifestyle (h/day)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
This measured with Adult Physical Activity Questionnaire (APAQ) Score from 0 to 21 points, 0 = no difficulty, and 21= major difficulties. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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VO2max (in ml/min/kg)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
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This physical ability is measured with a cardiorespiratory test on a cycloergometer |
at Month 3, Month 6 and Month 12 after implementation of the PA program
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Biceps muscular strength (kg)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
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Muscular strength will be assessed by biceps muscle strength (in kilograms) on the Handgrip (JAMAR Hand Dynamometer, UK) |
at Month 3, Month 6 and Month 12 after implementation of the PA program
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Patient Global Impression of Change (PGIC)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
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Health status will be assessed by the Patient Global Impression of Change (PGIC) and measured on a 7-point Likert scale, rated from 1 for "much worse" to 7 for "much better". |
at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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Hospital Anxiety and Depression Scale (HADS)
Tidsramme: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS) The HADS scale has 14 items scored from 0 to 3. 7 questions concern anxiety and 7 others the depressive dimension, which makes it possible to obtain two scores (maximum score for each score = 21). A score greater than or equal to 11 means that the anxiety or depression is anxiety or depression is certain. |
at Month 3, Month 6 and Month 12 after implementation of the PA program
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Number of patients involved in the intervention
Tidsramme: at Month 6 after implementation of the PA program
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Assessment of adherence as measured by the number of patients involved in the intervention |
at Month 6 after implementation of the PA program
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medico-economic impact of the care organization
Tidsramme: at Month 12 after implementation of the PA program
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Average cost saved per 100 patients treated in the "physical activity program group" compared to the "control group" |
at Month 12 after implementation of the PA program
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: David HUPIN, MD, CHU de Saint Etienne
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Vektorbårne sykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Infeksjoner
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Gram-negative bakterielle infeksjoner
- Borrelia-infeksjoner
- Spirochaetales infeksjoner
- Flåttbårne sykdommer
- Infeksjoner i sentralnervesystemet
- Bakterielle infeksjoner i sentralnervesystemet
- Oppførsel
- Lyme sykdom
- Lyme nevroborreliose
- Motorisk aktivitet
- Stillesittende atferd
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Community Health Services
- Atferdsdisipliner og aktiviteter
- Psykiske helsetjenester
- Rådgivning
Andre studie-ID-numre
- 22CH398
- 2022-A01120-43 (Annen identifikator: ANSM)
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