Respiratory Muscle Strength and Exercise Capacity in Smokers

NCT ID: NCT06650150

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-20

Study Completion Date

2025-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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COPD - Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PRISm

cigarette smokers with FEV1 below 80%

maximal inspiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

maximal expiratory pressure

Intervention Type DIAGNOSTIC_TEST

MEP will be measured with a specific device

6 minute walk test

Intervention Type DIAGNOSTIC_TEST

6mwt will be done by a phsyotherapist

preCOPD

cigarette smokers with normal pft

maximal inspiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

maximal expiratory pressure

Intervention Type DIAGNOSTIC_TEST

MEP will be measured with a specific device

6 minute walk test

Intervention Type DIAGNOSTIC_TEST

6mwt will be done by a phsyotherapist

COPD

cigarette smokers with FEV1/FVC less than 70%

maximal inspiratory pressure

Intervention Type DIAGNOSTIC_TEST

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

maximal expiratory pressure

Intervention Type DIAGNOSTIC_TEST

MEP will be measured with a specific device

6 minute walk test

Intervention Type DIAGNOSTIC_TEST

6mwt will be done by a phsyotherapist

Interventions

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maximal inspiratory pressure

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

Intervention Type DIAGNOSTIC_TEST

maximal expiratory pressure

MEP will be measured with a specific device

Intervention Type DIAGNOSTIC_TEST

6 minute walk test

6mwt will be done by a phsyotherapist

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Sabri Serhan OLCAY

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Muğla Training and Research Hospital

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MIP24

Identifier Type: -

Identifier Source: org_study_id

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