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Completed

NCT Number: NCT06650150

Respiratory Muscle Strength and Exercise Capacity in Smokers

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.

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Key information

Conditions

COPD - Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muğla Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

maximal inspiratory pressure

Diagnostic Test

maximal inspiratory pressure (mip) will be measured with a specific device

maximal expiratory pressure

Diagnostic Test

MEP will be measured with a specific device

6 minute walk test

Diagnostic Test

6mwt will be done by a phsyotherapist

Primary outcomes

  1. MIP

    Time frame: day 1

    MIP<80% in each grous

Secondary outcomes

  1. MEP

    Time frame: day 1

    mep< 80% in each group

Other outcomes

  1. 6MWT

    Time frame: day 1

    6MWT distance in each group

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Acronym: mip

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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