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临床试验/NCT04721080
NCT04721080Unknown不适用

Effects of Pulmonary Tuberculosis Sequelae on Functional Outcomes in Patients With COPD

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Exercise Capacity

研究概览

简要总结

It is known that there is a complex relationship between tuberculosis and COPD. Post-tuberculosis airway disease or COPD associated with tuberculosis occurs in a significant portion of tuberculosis patients. However, it was observed that mortality rates and exacerbation rates of COPD patients with tuberculosis sequel were higher. However, the effect of tuberculosis sequela on functional outcomes in COPD patients has not been investigated in the studies.

The aim of this study is to determine whether the previous tuberculosis sequelae has a functional effect on patients with COPD.

详细描述

This research is planned as a cross-sectional study. It will start within one week following the approval of the ethics committee and will be completed within one year. The universe of the study is S.B.Ü. Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital consists of patients who apply to Pulmonary Rehabilitation Outpatient Clinic. Participants will consist of two different groups: COPD patients with tuberculosis and COPD patients without tuberculosis. The voluntary principle will be taken into account in participating in the research.

Within the scope of the evaluation; Demographic and clinical information of the people who will participate in the study will be recorded, and Thorax CT and PFT examinations performed within the polyclinic service within the last 1 month will be evaluated. Saint George Respiratory Questionaire (SGRQ), 6-minute walk test (6MWT), Medical Research Council Dyspnea Scale (MRC), COPD assessment test (CAT) will be applied to the patients. Regarding the illness histories, the number of hospitalizations and emergency admissions in the last 1 year will be recorded. Detailed tuberculosis anamneses will also be taken from patients with tuberculosis sequelae.

研究设计

研究类型
Observational
观察模型
Other
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

  • Volunteering to participate in the study
  • Being over 18 years old
  • Having thorax CT in the last 1 month
  • Having PFT examination performed in the last 1 month

排除标准

  • Being in a COPD attack
  • The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.

结局指标

主要结局

Exercise Capacity

时间窗: 6 minutes- baseline

Six minutes walk test

次要结局

  • COPD Assessment(5 minutes- baseline)
  • Dyspnea Assessment(5 minutes- baseline)
  • Quality of Life Assessment(20 minutes- baseline)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilknur Naz

Assoc. Prof

Izmir Katip Celebi University

研究点 (1)

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