Efectividad de una intervención que combina actividad física adaptada y educación terapéutica en pacientes con síntomas crónicos atribuidos a la borreliosis de Lyme. (LyMouv')
Efectividad de una intervención que combina actividad física adaptada y educación terapéutica en pacientes con síntomas crónicos atribuidos a la borreliosis de Lyme. Estudio piloto aleatorizado, controlado y multicéntrico
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: David HUPIN, MD
- Número de teléfono: +33 0477828413
- Correo electrónico: David.Hupin@chu-st-etienne.fr
Copia de seguridad de contactos de estudio
- Nombre: Elisabeth BOTELHO-NEVERS, MD-PhD
- Número de teléfono: +33 0477120762
- Correo electrónico: elisabeth.botelho-nevers@chu-st-etienne.fr
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63000
- Aún no reclutando
- CHU Clermont-Ferrand
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Investigador principal:
- Clémence RICHAUD, MD
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Sub-Investigador:
- Clément THEIS, MD
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Saint-Etienne, Francia, 42055
- Reclutamiento
- Chu Saint Etienne
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Sub-Investigador:
- BOTELHO-NEVERS Élisabeth, PhD
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Sub-Investigador:
- CAZORLA Céline, MD
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Investigador principal:
- David HUPIN, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Otro: 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average level of moderate to vigorous physical activity (PA) - MET-h/week
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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average level of sedentary lifestyle (h/day)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David HUPIN, MD, CHU de Saint Etienne
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades transmitidas por vectores
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Infecciones
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por Borrelia
- Infecciones por espiroquetas
- Enfermedades transmitidas por garrapatas
- Infecciones del Sistema Nervioso Central
- Infecciones bacterianas del sistema nervioso central
- Comportamiento
- Enfermedad de Lyme
- Neuroborreliosis de Lyme
- Actividad del motor
- Comportamiento sedentario
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud comunitarios
- Disciplinas y actividades de comportamiento
- Servicios de salud mental
- Asesoramiento
Otros números de identificación del estudio
- 22CH398
- 2022-A01120-43 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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