COPD - Chronic Obstructive Pulmonary DiseasemipNCT06650150
Respiratory Muscle Strength and Exercise Capacity in Smokers
An observational study of COPD - Chronic Obstructive Pulmonary Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD - Chronic Obstructive Pulmonary Disease
- What is being tested?
- maximal inspiratory pressure, maximal expiratory pressure and 6 minute walk test
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 20 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Training and Research Hospital
Muğla, 48000
About this study
Official title: 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.
- Being tested
- maximal inspiratory pressure, maximal expiratory pressure, 6 minute walk test
- Keywords
- PRISm, Pre-COPD, COPD, MIP, 6mwt
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maximal inspiratory pressureDiagnostic test
maximal inspiratory pressure (mip) will be measured with a specific device
maximal expiratory pressureDiagnostic test
MEP will be measured with a specific device
6 minute walk testDiagnostic test
6mwt will be done by a phsyotherapist
| Study group | Role | What they receive |
|---|---|---|
| PRISm | cigarette smokers with FEV1 below 80% Receives: Diagnostic Test: maximal inspiratory pressure; Diagnostic Test: maximal expiratory pressure; Diagnostic Test: 6 minute walk test | |
| preCOPD | cigarette smokers with normal pft Receives: 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% Receives: Diagnostic Test: maximal inspiratory pressure; Diagnostic Test: maximal expiratory pressure; Diagnostic Test: 6 minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIP
MIP<80% in each grous
Measured: day 1
Secondary outcomes (1)
MEP
mep< 80% in each group
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 Oct 2024
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD - Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Serhan OLCAY, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650150
- Sponsor's protocol ID
- MIP24
- Acronym
- mip
- Status last verified
- Aug 2025
- First submitted
- 11 Oct 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Respiratory Muscle Strength and Exercise Capacity in Smokers With COPD, PRISm and Pre-COPD
- ClinicalTrials.gov ID
- NCT06650150
- Acronym / sponsor ID
- mip / MIP24
- Keywords
- PRISm, Pre-COPD, COPD, MIP, 6mwt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRISm | – | Diagnostic Test: maximal inspiratory pressure, Diagnostic Test: maximal expiratory pressure, Diagnostic Test: 6 minute walk testcigarette smokers with FEV1 below 80% |
| preCOPD | – | Diagnostic Test: maximal inspiratory pressure, Diagnostic Test: maximal expiratory pressure, Diagnostic Test: 6 minute walk testcigarette smokers with normal pft |
| COPD | – | Diagnostic Test: maximal inspiratory pressure, Diagnostic Test: maximal expiratory pressure, Diagnostic Test: 6 minute walk testcigarette smokers with FEV1/FVC less than 70% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maximal inspiratory pressuremaximal inspiratory pressure (mip) will be measured with a specific device | Diagnostic test | COPD, PRISm, preCOPD |
| maximal expiratory pressureMEP will be measured with a specific device | Diagnostic test | COPD, PRISm, preCOPD |
| 6 minute walk test6mwt will be done by a phsyotherapist | Diagnostic test | COPD, PRISm, preCOPD |
Primary outcome
MIP
Time frame: day 1
MIP<80% in each grous
1 secondary outcome
MEP
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD - Chronic Obstructive Pulmonary Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIP (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.