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- Ensaio Clínico NCT03244137
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.
It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments.
Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. However, it effects on cognitive dysfunction are not well known.
The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the Montreal Cognitive Assessment tool.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bois-Guillaume, França, 76230
- Bonnevie
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Le Havre, França, 76600
- Médrinal
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age > 18years;
- Chronic obstructive pulmonary disease stade III to IV;
- Referred for pulmonary rehabilitation.
Non Inclusion Criteria:
- Pregnancy or likely to be;
- History of psychiatric, neuro-vascular, cognitive disease or cranial trauma;
- Active alcoholism;
- Guardianship;
- Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks;
Exclusion Criteria:
- Interruption of the pulmonary rehabilitation program > 15 days;
- Disruption of the training before the 18th session;
- Less than 18 sessions in four month.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Pulmonary rehabilitation
The whole population will benefit from a comprehensive pulmonary rehabilitation program, including aerobic training, superior and inferior limb strength training, self-management and add-on to pulmonary rehabilitation as needed (i.e : electrical muscle stimulation, inspiratory muscle training, non-invasive ventilation, high flow nasal canula).
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See group description.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Baseline cognitive function
Prazo: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed at the beginning of the rehabilitation program : day 0
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Cognitive function after pulmonary rehabilitation
Prazo: Cognitive function is assessed at the end of the rehabilitation program : day 60
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed at the end of the rehabilitation program : day 60
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Cognitive function : follow up
Prazo: Cognitive function is assessed 3 month after rehabilitation : day 150
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed 3 month after rehabilitation : day 150
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Change in cognitive function from baseline to the end of pulmonary rehabilitation
Prazo: Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0)
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0)
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Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up
Prazo: Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60)
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Anxiety and depression : baseline
Prazo: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
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Anxiety and depression : end of pulmonary rehabilitation
Prazo: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assessed at the end of the rehabilitation program : day 60
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Anxiety and depression : follow up
Prazo: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
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Quality of life : baseline
Prazo: Quality of life is assessed at the beginning of the rehabilitation program : day 0
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed at the beginning of the rehabilitation program : day 0
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Quality of life : end of pulmonary rehabilitation
Prazo: Quality of life is assessed at the end of the rehabilitation program : day 60
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed at the end of the rehabilitation program : day 60
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Quality of life : follow-up
Prazo: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
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Functional capacity (six-minute stepper test) : baseline
Prazo: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity is assessed with the six-minute stepper test
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Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
Prazo: Functional capacity is assessed at the end of the rehabilitation program : day 60
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Functional capacity is assessed with the six-minute stepper test
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Functional capacity is assessed at the end of the rehabilitation program : day 60
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Functional capacity (six-minute walk test) : baseline
Prazo: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity is assessed with the six-minute walk test
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Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Adherence
Prazo: Adherence is assessed at the end of the rehabilitation program : day 60
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Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions
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Adherence is assessed at the end of the rehabilitation program : day 60
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Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)
Prazo: The relation is assessed between baseline demographic data at day 0
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Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation
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The relation is assessed between baseline demographic data at day 0
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cuvelier Antoine, Prof, PhD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
- Cadeira de estudo: Muir Jean-François, Prof, PhD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France.
- Cadeira de estudo: Tardif Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Cadeira de estudo: Viacroze Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- Cadeira de estudo: Debeaumont David, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- Cadeira de estudo: Patout Maxime, MD, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- Cadeira de estudo: Lamia Bouchra, Prof, PhD, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France.
- Cadeira de estudo: Quieffin Jean, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- Cadeira de estudo: Prieur Guillaume, PT, MsC, Service de pneumologie, Groupe Hospitalier du Havre, Fr
- Cadeira de estudo: Médrinal Clément, PT, MsC, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
- Cadeira de estudo: Gravier Francis-Edouard, PT, ADIR Association, Bois-Guillaume, France
- Cadeira de estudo: Bonnevie Tristan, PT, MsC, ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PR-COPD
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