Respiratory Muscle Strength and Exercise Capacity in Smokers (mip)

Muğla Sıtkı Koçman University

Status: Completed

Conditions: COPD - Chronic Obstructive Pulmonary Disease

Treatments: Diagnostic Test: maximal expiratory pressure; Diagnostic Test: maximal inspiratory pressure; Diagnostic Test: 6 minute walk test

Study type: Observational

Funder types: Other

Identifiers

NCT06650150

MIP24

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 3 patient groups

PRISm

Description:

cigarette smokers with FEV1 below 80%

Treatment:

Diagnostic Test: 6 minute walk test

Diagnostic Test: maximal inspiratory pressure

Diagnostic Test: maximal expiratory pressure

preCOPD

Description:

cigarette smokers with normal pft

Treatment:

Diagnostic Test: 6 minute walk test

Diagnostic Test: maximal inspiratory pressure

Diagnostic Test: maximal expiratory pressure

COPD

Description:

cigarette smokers with FEV1/FVC less than 70%

Treatment:

Diagnostic Test: 6 minute walk test

Diagnostic Test: maximal inspiratory pressure

Diagnostic Test: maximal expiratory pressure