Effectiviteit van een interventie die aangepaste lichaamsbeweging en therapeutische educatie combineert bij patiënten met chronische symptomen toegeschreven aan Lyme-borreliose. (LyMouv')
Effectiviteit van een interventie die aangepaste lichaamsbeweging en therapeutische educatie combineert bij patiënten met chronische symptomen toegeschreven aan Lyme-borreliose. Multicenter, gecontroleerde, gerandomiseerde 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: David HUPIN, MD
- Telefoonnummer: +33 0477828413
- E-mail: David.Hupin@chu-st-etienne.fr
Studie Contact Back-up
- Naam: Elisabeth BOTELHO-NEVERS, MD-PhD
- Telefoonnummer: +33 0477120762
- E-mail: elisabeth.botelho-nevers@chu-st-etienne.fr
Studie Locaties
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Clermont-Ferrand, Frankrijk, 63000
- Nog niet aan het werven
- CHU Clermont-Ferrand
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Hoofdonderzoeker:
- Clémence RICHAUD, MD
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Onderonderzoeker:
- Clément THEIS, MD
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Saint-Etienne, Frankrijk, 42055
- Werving
- Chu Saint Etienne
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Onderonderzoeker:
- BOTELHO-NEVERS Élisabeth, PhD
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Onderonderzoeker:
- CAZORLA Céline, MD
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Hoofdonderzoeker:
- David HUPIN, MD
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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 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
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: 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). |
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Ander: 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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Average level of moderate to vigorous physical activity (PA) - MET-h/week
Tijdsspanne: 1 year after implementation of the PA program
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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average level of sedentary lifestyle (h/day)
Tijdsspanne: 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
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Average level of moderate to vigorous physical activity (PA) - MET-h/week
Tijdsspanne: 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)
Tijdsspanne: at Month 3, Month 6 and Month 12 after implementation of the PA program
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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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: at Month 3, Month 6 and Month 12 after implementation of the PA program
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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
Tijdsspanne: 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
Tijdsspanne: 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
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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 (Geschat)
Studie voltooiing (Geschat)
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
- Vector overgedragen ziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Gram-negatieve bacteriële infecties
- Borrelia-infecties
- Spirochaetales-infecties
- Door teken overgedragen ziekten
- Infecties van het centrale zenuwstelsel
- Bacteriële infecties van het centrale zenuwstelsel
- Gedrag
- Ziekte van Lyme
- Lyme Neuroborreliose
- Motorische activiteit
- Sedentair gedrag
- Gezondheidsdiensten
- Gezondheidszorgfaciliteiten personeel en diensten
- Community Health Services
- Gedragsdisciplines en activiteiten
- Geestelijke gezondheidszorg
- Counseling
Andere studie-ID-nummers
- 22CH398
- 2022-A01120-43 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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