Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients (COPD)
2014年5月17日 更新者：Marie Carmen Valenza、Universidad de Granada
Clinical Profile and Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients
Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life.
The hypothesis of this study is to examine the relationship between cognitive status and clinical profile (respiratory, sleep quality, nutritional status) in patients with chronic obstructive pulmonary disease in two different moments: exacerbation or stable situation.
研究概览
详细说明
Chronic obstructive pulmonary disease is a pathology with a systemic impact with a progressive evolution that is characterized by the presence of chronic airflow obstruction.
Patients with COPD may have problems with cognitive functioning, either globally or in single cognitive domains, such as information processing, attention and concentration, memory, executive functioning and self-regulation.
Several studies have determined the prevalence of cognitive impairment in COPD compared to healthy control subjects, reaching very high levels, 36% of COPD patients with mild cognitive impairment compared with 12 % non- COPD subjects.
研究类型
观察性的
注册 (预期的)
60
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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Granada、西班牙、18071
- 招聘中
- Department of Physical Therapy
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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
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients diagnosed of chronic obstructive pulmonary disease.
描述
Inclusion Criteria:
- Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable.
- Signed written consent.
- Medical approval for inclusion
Exclusion Criteria:
- Heart disease.
- Neurological patients.
- Severe cognitive impairment in order not to complete the assessment.
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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Stable and exacerbated patients
Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation.
Cognitive assessment of these patients will be performed.
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Patients are going to be assessed regarding the outcome measures
其他名称：
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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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Cognitive impairment
大体时间：Baseline
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The cognitive impairment will be measured using the Montreal Cognitive Assessment.
The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
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Baseline
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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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Sleep quality
大体时间：Baseline
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Participants are going to complete the Pittsburgh Quality of Sleep Index.
This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
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Baseline
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Activity monitoring
大体时间：Baseline
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The accelerometer Armband is going to be used for activity monitoring.
It measures the intensity of the activity during 12 hours.
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Baseline
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Nutritional state
大体时间：Baseline
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Mini Nutritional Assessment has been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes.
It is composed of simple measurements and brief questions that can be completed in about 10 min
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Baseline
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Quality of life
大体时间：Baseline
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Quality of life associated with health is going to be measured with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
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Baseline
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Cough
大体时间：Baseline
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The Leicester Cough Questionnaire-acute is a validated cough-related health status questionnaire designed for patients with chronic cough.
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Baseline
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Comorbidities
大体时间：Baseline
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Comorbidities are going to be measured with the Charlson comorbidity index.
The Charlson comorbidity index predicts the ten-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions).
Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.
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Baseline
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Anxiety and depression
大体时间：Baseline
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Patients are going to completed the Hospital Anxiety and Depression Scale composed of statements relevant to either generalized anxiety or depression.
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Baseline
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Cognitive flexibility
大体时间：Baseline
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The cognitive flexibility of patients is measured using the Trial Making Test.
This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.
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Baseline
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Forced vital capacity
大体时间：Baseline
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Forced vital capacity is going to be measured with a spirometer as recommended by the American Thoracic Society
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Baseline
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Forced expiratory volume in the first second
大体时间：Baseline
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Forced expiratory volume in the first second is going to be measured with a spirometer as recommended by the American Thoracic Society
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Baseline
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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。
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
2014年4月1日
初级完成 (预期的)
2014年8月1日
研究完成 (预期的)
2014年12月1日
研究注册日期
首次提交
2014年5月17日
首先提交符合 QC 标准的
2014年5月17日
首次发布 (估计)
2014年5月21日
研究记录更新
最后更新发布 (估计)
2014年5月21日
上次提交的符合 QC 标准的更新
2014年5月17日
最后验证
2014年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.