Eficácia de uma Intervenção Combinando Atividade Física Adaptada e Educação Terapêutica em Pacientes com Sintomas Crônicos Atribuídos à Borreliose de Lyme. (LyMouv')
Eficácia de uma Intervenção Combinando Atividade Física Adaptada e Educação Terapêutica em Pacientes com Sintomas Crônicos Atribuídos à Borreliose de Lyme. Estudo Piloto Multicêntrico, Controlado e Randomizado
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: David HUPIN, MD
- Número de telefone: +33 0477828413
- E-mail: David.Hupin@chu-st-etienne.fr
Estude backup de contato
- Nome: Elisabeth BOTELHO-NEVERS, MD-PhD
- Número de telefone: +33 0477120762
- E-mail: elisabeth.botelho-nevers@chu-st-etienne.fr
Locais de estudo
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Clermont-Ferrand, França, 63000
- Ainda não está recrutando
- CHU Clermont-Ferrand
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Investigador principal:
- Clémence RICHAUD, MD
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Subinvestigador:
- Clément THEIS, MD
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Saint-Etienne, França, 42055
- Recrutamento
- Chu Saint Etienne
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Subinvestigador:
- BOTELHO-NEVERS Élisabeth, PhD
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Subinvestigador:
- CAZORLA Céline, MD
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Investigador principal:
- David HUPIN, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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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Outro: 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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Average level of moderate to vigorous physical activity (PA) - MET-h/week
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
average level of sedentary lifestyle (h/day)
Prazo: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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
Prazo: 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
|
|
Average level of sedentary lifestyle (h/day)
Prazo: 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
|
|
VO2max (in ml/min/kg)
Prazo: 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)
Prazo: 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)
Prazo: at Month 3, Month 6 and Month 12 after implementation of the PA program
|
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)
Prazo: 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
|
|
Number of patients involved in the intervention
Prazo: at Month 6 after implementation of the PA program
|
Assessment of adherence as measured by the number of patients involved in the intervention |
at Month 6 after implementation of the PA program
|
|
medico-economic impact of the care organization
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David HUPIN, MD, CHU de Saint Etienne
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças transmitidas por vetores
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Infecções
- Infecções bacterianas
- Infecções Bacterianas e Micoses
- Infecções por Bactérias Gram-negativas
- Infecções por Borrelia
- Infecções por Spirochaetales
- Doenças transmitidas por carrapatos
- Infecções do Sistema Nervoso Central
- Infecções bacterianas do sistema nervoso central
- Comportamento
- Doença de Lyme
- Neuroborreliose de Lyme
- Atividade motora
- Comportamento Sedentário
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Serviços de Saúde Comunitária
- Disciplinas e atividades comportamentais
- Serviços de Saúde Mental
- Aconselhamento
Outros números de identificação do estudo
- 22CH398
- 2022-A01120-43 (Outro identificador: ANSM)
Plano para dados de participantes individuais (IPD)
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