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临床试验/NCT06650150
NCT06650150已完成不适用

Comparative Study on Respiratory Muscle Strength and Exercise Capacity in Smokers With COPD, PRISm and Pre-COPD

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
MIP

研究概览

简要总结

This cross-sectional study aims to evaluate the respiratory muscle strength and physical capacity of symptomatic adult smokers in Muğla. The study population will be the patients who were admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024. The primary outcome is the proportion of individuals with Maximum Inspiratory Pressure (MIP) below 80%. Secondary outcomes include the 6-Minute Walk Test (6MWT) distance, Maximum Expiratory Pressure (MEP), and COPD Assessment Test (CAT) scores. Smokers will be categorized into COPD, PRISm, and Pre-COPD groups. The study will adjust for BMI as a key confounder and assess the modifying effects of gender, smoking habits, and age. Ethical approval and informed consent will be obtained, with data analysis focusing on descriptive statistics, comparative analysis, and regression models to understand the impact of smoking on respiratory health.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • At least 5 packages of cigarette smokers who have an appropriate PFT done at our lab. (pulmonary function test must be performed at evaluable standards according to ERS/ATS guidelines)

排除标准

  • Respiratory infection at the time of measurement (upper or lower resp. tract, viral or bacterial infections)
  • Presence of chronic respiratory diseases (Asthma, IPF, Bronchiectasis, [except COPD])
  • Exacerbation due to chronic respiratory diseases (except mild COPD exacerbation)
  • Neuromuscular disease (ALS, Guillain-Bare syndrome, Muscular dystrophies, Myasthenia gravis)
  • Restrictive pulmonary disease (IPF, Sarcoidozis, Progresif Pulmonary Fibrosis)

结局指标

主要结局

MIP

时间窗: day 1

MIP\<80% in each grous

次要结局

  • MEP(day 1)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabri Serhan OLCAY

Assistant Professor

Muğla Sıtkı Koçman University

研究点 (1)

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