Respiratory Muscle Strength and Exercise Capacity in Smokers

NCT06650150 | Completed DMC

• 1 other identifier: MIP24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD - Chronic Obstructive Pulmonary Disease

Keywords

PRISm; Pre-COPD; COPD; MIP; 6mwt

Outcome Measures

Primary Outcomes (1)

• MIP

  MIP\<80% in each grous

  day 1

Secondary Outcomes (1)

• MEP

  day 1

Other Outcomes (1)

• 6MWT

  day 1

Study Arms (3)

PRISm

cigarette smokers with FEV1 below 80%

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

preCOPD

cigarette smokers with normal pft

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

COPD

cigarette smokers with FEV1/FVC less than 70%

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

Interventions

maximal inspiratory pressure DIAGNOSTIC_TEST

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

COPD; PRISm; preCOPD

maximal expiratory pressure DIAGNOSTIC_TEST

MEP will be measured with a specific device

COPD; PRISm; preCOPD

6 minute walk test DIAGNOSTIC_TEST

6mwt will be done by a phsyotherapist

COPD; PRISm; preCOPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of symptomatic smokers admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Maximal Respiratory Pressures; Walk Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 21, 2024
• Study Start: October 20, 2024
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

TU (1)