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临床试验/NCT04394299
NCT04394299Unknown不适用

Cognitive Impairment and Clinical Characteristics in Patients With Chronic Obstructive Pulmonary Disease: Retrospective Study

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 1,476 人开始时间: 2020年4月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,476
试验地点
1
主要终点
Cognitive impairment

研究概览

简要总结

Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). A recent study shows that lung disease, and specifically Chronic obstructive pulmonary disease (COPD) are associated to a greater risk of CI in a population of 14,184 individuals followed for over 23 years. Moreover, the study shows that low forced expiratory volume in 1 second (FEV1) is associated to an increased risk of dementia and MCI, indipendently of smoking habit.

详细描述

Chronic obstructive pulmonary disease (COPD) is considered "a progressive but potentially treatable and preventable disease". The clinical view of COPD is moved from a lung-centered model to a novel one that considers COPD as an "umbrella" term encompassing different pulmonary and extra-pulmonary manifestations.

Prior researches suggest the presence of impaired lung function may be linked to cognitive impairment (CI). Among these studies, one prospective found that a diagnosis of COPD is associated with an increased risk of mild cognitive impairment (MCI), mainly nonamnestic MCI (NA-MCI), in a dose-response relationship between COPD duration and risk of MCI. Moreover, CI associated with severe COPD stage increases mortality. Among these studies only one shows that CI decreases adherence to pharmacological and non-pharmacological therapies. However, while it is well known that an MMSE score of 23-24 points or less is predictive of poor inhaler technique no studies report the impact of CI on PR outcomes. It has been reported that patients with MMSE < 24 walk lesser, at the basal level, than patients with a MMSE score > 24 (146 ±134 versus 242 ± 152 m) in the six minutes walking tests (6MWT) but no data are reported after rehabilitation. On the other hand, some papers report an association between participation in exercise rehabilitation programs and enhanced performance on cognitive tests.

The aim of this study is to compare cognitive functioning in patients with COPD referred for pulmonary rehabilitation to the response of the programme itself. More specific objectives of the present study are to:

  • Study whether and to what extent CI in patients with COPD impacts outcomes of pulmonary rehabilitation such as 6MW distance (6MWD), Barthel and Borg scales for assessing dyspnea, Maugeri Foundation Respiratory Failure Questionnaire and the disease-specific respiratory quality of life (QoL) [St. George's Respiratory Questionnaire (SGRQ) and the Medical Research Council (MRC)].
  • Investigate clinical and demographic characteristics of patients with COPD with cognitive impairment.

The hypothesize is that COPD patients with CI have worse response to PR compared with patients with no CI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted consecutively

排除标准

  • 未提供

结局指标

主要结局

Cognitive impairment

时间窗: 2 months

Mini Mental State Evaluation score from zero to 30

Response to Pulmonary Rehabilitation

时间窗: 3 months

Evaluation using six minutes walking test

次要结局

  • Evaluation of responders according to six minutes walking test(3 months)

研究者

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

Dr. Patrizia Russo

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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