Respiratory Muscle Strength and Exercise Capacity in Smokers (mip)

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

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.

Study Overview

• Status: Completed
• Conditions: COPD - Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: maximal inspiratory pressure; Diagnostic test: maximal expiratory pressure; Diagnostic test: 6 minute walk test

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey, 48000
    • Muğla Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRISm; cigarette smokers with FEV1 below 80%	Diagnostic test: maximal inspiratory pressure; maximal inspiratory pressure (mip) will be measured with a specific device; Diagnostic test: maximal expiratory pressure; MEP will be measured with a specific device; Diagnostic test: 6 minute walk test; 6mwt will be done by a phsyotherapist
preCOPD; cigarette smokers with normal pft	Diagnostic test: maximal inspiratory pressure; maximal inspiratory pressure (mip) will be measured with a specific device; Diagnostic test: maximal expiratory pressure; MEP will be measured with a specific device; Diagnostic test: 6 minute walk test; 6mwt will be done by a phsyotherapist
COPD; cigarette smokers with FEV1/FVC less than 70%	Diagnostic test: maximal inspiratory pressure; maximal inspiratory pressure (mip) will be measured with a specific device; Diagnostic test: maximal expiratory pressure; MEP will be measured with a specific device; Diagnostic test: 6 minute walk test; 6mwt will be done by a phsyotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MIP	MIP<80% in each grous	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEP	mep< 80% in each group	day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	6MWT distance in each group	day 1

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Actual): July 20, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: COPD; MIP; PRISm; Pre-COPD; 6mwt
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MIP24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No