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Clinical Trials/NCT06650150
NCT06650150
Completed
N/A

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

Muğla Sıtkı Koçman University1 site in 1 country150 target enrollmentOctober 20, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
COPD - Chronic Obstructive Pulmonary Disease
Sponsor
Muğla Sıtkı Koçman University
Enrollment
150
Locations
1
Primary Endpoint
MIP
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2024
End Date
July 20, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Sabri Serhan OLCAY

Assistant Professor

Muğla Sıtkı Koçman University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

MIP

Time Frame: day 1

MIP\<80% in each grous

Secondary Outcomes

  • MEP(day 1)

Study Sites (1)

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