COPDNCT07249567
Comparison of Patients With COPD and PRISM
An observational study of COPD, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2025to 30 Mar 2026
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COPD and PRSIm will be included and compared with healthy controls
Who may be able to join
- For the COPD group:
- Being >40 years old,
- Being diagnosed with COPD,
- Being clinically stable,
- Volunteering to participate in the study.
- For the PRISm group:
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- Being >40 years old,
- Being diagnosed with PRISm,
- Volunteering to participate in the study.
- For the healthy control group:
- Being >40 years old,
- Volunteering to participate in the study.
Who cannot join
- For the COPD group:
- Having severe orthopedic, neurological, or cardiac diseases,
- Being in a COPD exacerbation,
- Having a comorbid lung disease,
- Being on clinically unstable medication,
- Voluntarily not participating in the study.
Show all 14Show fewer
- For the PRISm group:
- Being diagnosed with COPD,
- Having severe orthopedic, neurological, or cardiac diseases,
- Having a comorbid lung disease,
- Voluntarily not participating in the study.
- For the healthy control group:
- Having a known chronic disease,
- Voluntarily not participating in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
About this study
Official title: Comparison of Respiratory and Peripheral Muscle Strength, Exercise Capacity, and Muscle Oxygenation in Individuals With COPD and PRISM
COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. PRISm can predispose to the development of COPD and exacerbations, and can reduce exercise capacity by reducing respiratory function and oxygen consumption. There are no studies in the literature comparing respiratory muscle strength, peripheral muscle strength, and oxygenation in PRISm, COPD, and healthy individuals. Therefore, this study aimed to evaluate these parameters and compare them with healthy individuals.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable multisystem lung disease characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to airway abnormalities, causing persistent and often progressive airflow limitation. PRISm is defined as a spirometry pattern that is not always a stable phenotype but should be considered "sick" because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. Recently, PRISm has been identified as a subtype more prone to developing COPD or experiencing acute exacerbations. In addition to affecting the respiratory muscles, PRISm's effects on respiratory function lead to decreased body oxygen consumption and increased dyspnea. PRISm can also lead to decreased exercise capacity due to the respiratory problems and dyspnea it causes. Although there are not enough studies in the literature investigating exercise capacity and lung functions on behalf of PRISm, no previous study comparing respiratory muscle strength, peripheral muscle strength and oxygenation in PRISm, COPD and healthy individuals has been found.
- Conditions
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Patients with chronic obstructive pulmonary disease will be included. | |
| Patients with PRISm | Patients with preserved ratio impaired spirometry will be included. | |
| Control | Healthy controls will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Measured: Baseline
Lower extremity exercise capacity
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Measured: Baseline
Peripheral muscle strength
Peripheral muscle strength will be evaluated with a dynamometer.
Measured: Baseline
Muscle oxygenation
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Measured: Baseline
Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.
Measured: Baseline
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.
Measured: Baseline
Dyspnea
Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.
Measured: Baseline
Clinical symptoms
The COPD Assessment Test will be evaluated. This scale scored on a 0-5 point scale to assess symptoms associated with COPD. As the score increases, the symptom increases.
Measured: Baseline
Secondary outcomes (5)
Pulmonary function (Forced vital capacity (FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.
Measured: Baseline
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.
Measured: Baseline
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Measured: Baseline
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.
Measured: Baseline
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start5 Oct 2025
- Primary completion5 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Güneş, PhD, Principal investigator, Karabuk UniversityRabia Hande Avcı, MD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249567
- Sponsor's protocol ID
- Karabuk-2383
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory and Peripheral Muscle Strength, Exercise Capacity, and Muscle Oxygenation in Individuals With COPD and PRISM
- ClinicalTrials.gov ID
- NCT07249567
- Acronym / sponsor ID
- Karabuk-2383
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 25 Nov 2025 (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.
COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. PRISm can predispose to the development of COPD and exacerbations, and can reduce exercise capacity by reducing respiratory function and oxygen consumption. There are no studies in the literature comparing respiratory muscle strength, peripheral muscle strength, and oxygenation in PRISm, COPD, and healthy individuals. Therefore, this study aimed to evaluate these parameters and compare them with healthy individuals.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable multisystem lung disease characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to airway abnormalities, causing persistent and often progressive airflow limitation. PRISm is defined as a spirometry pattern that is not always a stable phenotype but should be considered "sick" because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. Recently, PRISm has been identified as a subtype more prone to developing COPD or experiencing acute exacerbations. In addition to affecting the respiratory muscles, PRISm's effects on respiratory function lead to decreased body oxygen consumption and increased dyspnea. PRISm can also lead to decreased exercise capacity due to the respiratory problems and dyspnea it causes. Although there are not enough studies in the literature investigating exercise capacity and lung functions on behalf of PRISm, no previous study comparing respiratory muscle strength, peripheral muscle strength and oxygenation in PRISm, COPD and healthy individuals has been found.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | –Patients with chronic obstructive pulmonary disease will be included. |
| Patients with PRISm | – | –Patients with preserved ratio impaired spirometry will be included. |
| Control | – | –Healthy controls will be included. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD and PRSIm will be included and compared with healthy controls
Key inclusion criteria (12 listed)
- Being >40 years old,
- Being diagnosed with COPD,
- Being clinically stable,
- Volunteering to participate in the study.
- Being >40 years old,
Key exclusion criteria (14 listed)
- Having severe orthopedic, neurological, or cardiac diseases,
- Being in a COPD exacerbation,
- Having a comorbid lung disease,
- Being on clinically unstable medication,
- Voluntarily not participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper extremity exercise capacity
Time frame: Baseline
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Lower extremity exercise capacity
Time frame: Baseline
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Peripheral muscle strength
Time frame: Baseline
Peripheral muscle strength will be evaluated with a dynamometer.
Muscle oxygenation
Time frame: Baseline
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Respiratory Muscle Strength
Time frame: Baseline
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.
Respiratory Muscle Endurance
Time frame: Baseline
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.
Dyspnea
Time frame: Baseline
Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.
Clinical symptoms
Time frame: Baseline
The COPD Assessment Test will be evaluated. This scale scored on a 0-5 point scale to assess symptoms associated with COPD. As the score increases, the symptom increases.
5 secondary outcomes
Pulmonary function (Forced vital capacity (FVC)
Time frame: Baseline
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Time frame: Baseline
Pulmonary function (FEV1 / FVC)
Time frame: Baseline
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: Baseline
Pulmonary function (Peak flow rate (PEF))
Time frame: Baseline
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Musa Güneş, PhD principal investigator
Karabuk University
Rabia Hande Avcı, MD principal investigator
Karabuk University
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, run by Karabuk 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 12 inclusion and 14 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 29 Oct 2026. 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?
Upper extremity exercise capacity (time frame: Baseline). The study lists 8 primary outcomes in all. 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 29 Oct 2026.