Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
2020年1月6日 更新者：ADIR Association
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.
研究概览
研究类型
观察性的
注册 (实际的)
56
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bois-Guillaume、法国、76230
- Bonnevie
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Le Havre、法国、76600
- Médrinal
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Every patients with chronic obstructive pulmonary disease referred for pulmonary rehabilitation in ADIR Association (Rouen, France) and the Groupe Hospitalier du Havre (Le Havre, France) will be assessed for eligibility.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Baseline cognitive function
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Anxiety and depression : baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：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.
- 学习椅：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.
- 学习椅：Tardif Catherine, MD、CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- 学习椅：Viacroze Catherine, MD、CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- 学习椅：Debeaumont David, MD、CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- 学习椅：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
- 学习椅：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.
- 学习椅：Quieffin Jean, MD、Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- 学习椅：Prieur Guillaume, PT, MsC、Service de pneumologie, Groupe Hospitalier du Havre, Fr
- 学习椅：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
- 学习椅：Gravier Francis-Edouard, PT、ADIR Association, Bois-Guillaume, France
- 学习椅：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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月4日
初级完成 (实际的)
2019年12月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2017年7月31日
首先提交符合 QC 标准的
2017年8月8日
首次发布 (实际的)
2017年8月9日
研究记录更新
最后更新发布 (实际的)
2020年1月7日
上次提交的符合 QC 标准的更新
2020年1月6日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PR-COPD
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Pulmonary rehabilitation的临床试验
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IRCCS Eugenio Medea招聘中