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临床试验/NCT02143700
NCT02143700Unknown不适用

Clinical Profile and Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Cognitive impairment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable.
  • Signed written consent.
  • Medical approval for inclusion

排除标准

  • Heart disease.
  • Neurological patients.
  • Severe cognitive impairment in order not to complete the assessment.

结局指标

主要结局

Cognitive impairment

时间窗: Baseline

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.

次要结局

  • Sleep quality(Baseline)
  • Activity monitoring(Baseline)
  • Nutritional state(Baseline)
  • Quality of life(Baseline)
  • Cough(Baseline)
  • Comorbidities(Baseline)
  • Anxiety and depression(Baseline)
  • Cognitive flexibility(Baseline)
  • Forced vital capacity(Baseline)
  • Forced expiratory volume in the first second(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Assisstant professor

Universidad de Granada

研究点 (1)

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