Chronic Obstructive Pulmonary Disease (COPD)NCT06682832
Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Preserved Ratio Impaired Spirometry (PRISM), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2025to Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: COPD and PRISm patients referred to the Cardiopulmonary Rehabilitation Unit for routine physiotherapy and rehabilitation will be included in the study. The group of healthy individuals will be formed by including the healthy siblings of the participants who are age and gender compatible with the COPD and PRISm groups, and the volunteers among the relatives and acquaintances of the researchers. 54 individuals will be included in the study.
Who may be able to join
- PRISm group inclusion criteria;
- Being >40 years old,
- Being diagnosed with PRISm,
- Volunteering to participate in the study,
- Not having any orthopaedic or neurological problems that may prevent participation in the measurements,
- Co-operation with measurements
Show all 14Show fewer
- Being >40 years old,
- Being diagnosed with COPD,
- To be clinically stable,
- Volunteering to participate in the study.
- Being >40 years old,
- Volunteering to participate in the study,
- No known chronic health problems,
- To be able to co-operate with the measurements.
Who cannot join
- PRISm group exclusion criteria;
- Being diagnosed with COPD,
- Severe orthopaedic, neurological and cardiac diseases
- Not volunteering to participate in the study
- Severe orthopaedic, neurological and cardiac diseases,
- Being in COPD exacerbation period,
Show all 10Show fewer
- Not volunteering to participate in the study.
- Healthy individuals exclusion criteria;
- Having a known chronic disease,
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06560
Ece Kumlu, 05535637892, eekumlu@gmail.com
About this study
Official title: Comparison of Exercise Capacity, Muscle Strength and Oxygenation, Arterial Stiffness, Physical Activity and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease and Impaired Spirometry With Preserved Ratio
Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. As research continues to evolve, PRISm needs to be recognized as a critical component of pulmonary assessments and at-risk individuals need to be provided with appropriate treatment and follow-up to prevent progression to COPD. There are no studies in the literature comparing PRISm, respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in COPD and healthy individuals. The aim of this study was to compare respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy subjects.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable multisystemic lung disease characterised by chronic respiratory symptoms (dyspnoea, cough, expectoration and/or exacerbations) due to abnormalities in the airways causing permanent and often progressive airflow limitation. In a part of the individuals with affected lung function, FEV1/FVC is preserved after bronchodilation (≥ 70%), whereas FEV1 is lower than expected (< 80%). This condition, which describes a preserved ratio impaired spirometry (PRISm), is highly prevalent in current and former smokers. PRISm is defined as a spirometry pattern that is not always a stable phenotype, but should be considered ''patient'' because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. There are studies showing that pulmonary functions, exercise capacity and quality of life are impaired in individuals with PRISm, whose pathophysiology is unclear and clinical effects are not known. In addition to the insufficient number of studies investigating exercise capacity, quality of life and pulmonary function on behalf of PRISm in the literature, no previous studies comparing respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy individuals have been found. In this study, aimed to investigate whether the parameters (symptoms, respiratory and peripheral muscle strength, physical activity level, exercise capacity, muscle oxygenation, arterial stiffness), which have been proven to be affected in the COPD group due to their clinical similarity with COPD, are affected in the PRISm group. A total of 54 individuals, 18 in each group, will be included in the study. Pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life will be compared in PRISm, COPD and healthy individuals. Our study will be able to reveal the clinical status of PRISM patients in terms of pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life compared to COPD group and healthy group and will be a guide in planning pulmonary rehabilitation programmes.
- Keywords
- COPD, PRISm, exercise capacity, muscle strength, arterial stiffness, physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
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 |
|---|---|---|
| COPD group | Consisted of 18 individuals over 40 years of age with chronic obstructive pulmonary disease. | |
| PRISm group | Consisted of 18 individuals over 40 years of age with preserved ratio impaired spirometry. | |
| Healthy group | Consisted of 18 healthy individuals over 40 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.
Measured: 6 minutes
Arterial Stiffness
Arterial stiffness is evaluated with a Tel-O-Graph CT device with oscillometric cuff (I.E.M., Stolberg, Germany). Central systolic blood pressure, pulse wave velocity (PWV) and augmentation index (Alx) are measured with brachial pulse waves. After a five-minute rest, three measurements are performed in a quiet environment.
Measured: 20 minutes
Muscle Oxygenation
Muscle oxygenation is assessed using a measurement and monitoring device (Moxy Fortiori Design LLC, Minnesota, USA). The device is placed on the vastus lateralis muscle. Resting measurements are taken for at least 3 minutes until the muscle oxygen saturation (SmO2) signal stabilizes. SmO2 at rest, SmO2 during 6DYT and during the first minute of recovery, and mean SmO2 are recorded.
Measured: 10 minutes
Physical Activity
Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.
Measured: 5 minutes
Secondary outcomes (12)
Body Composition
Body composition is evaluated by Bioelectrical Impedance Analysis method. For body composition measurement, it is completed in an upright posture, without moving, leaving a space between the arms and torso, ensuring full contact of the hands and feet with the electrodes. Muscle mass, fat mass, body fat percentage (BMR) and lean body weight (LBW) values of the participants are recorded.
Measured: 5 minutes
Respiratory Muscle Strength
Respiratory Muscle Strength is measured using a mouth pressure meter (MicroRPM, Micro Medical, Rochester, UK) and personalized antibacterial and antiviral disposable filters; maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) values are determined.
Measured: 10 minutes
Peripheral Muscle Strength
Peripheral muscle strength is measured by knee extensor muscle strength measurement. Measurements are performed with a portable digital muscle strength measuring device (01165 Manual Muscle Tester, Lafayette Instrument Co. Lafayette, USA).
Measured: 5 minutes
Sleep Quality
Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI). The scale assesses sleep quality and sleep disturbance over the past month. The scale includes 24 questions. The total PDQI score ranges from 0-21 points. A total score greater than 5 points indicates "poor sleep quality".
Measured: 5 minutes
COPD Assessment Test
The COPD Assessment Test, COPD Assessment Test Questionnaire (CAT), is an eight-item self-reported scale scored on a 0-5 point scale to assess symptoms associated with COPD. As a clinical impact, a total score of less than 10 points is interpreted as few symptoms, while a score of more than 10 points is interpreted as more symptoms.
Measured: 5 minutes
Quality of Life
Quality of Life will be assessed with the St George Respiratory Questionnaire (SGRQ). SGRQ is a 76-item health-related quality of life assessment questionnaire.
Measured: 10 minutes
Symptoms
Symptoms, dyspnea and fatigue level are assessed. Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. Fatigue levels of individuals will be assessed using the Fatigue Severity Scale (FSS).
Measured: 8 minutes
Pulmonary Function Test (forced vital capacity (FVC))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced vital capacity (FVC). FVC is the volume of air exhaled with rapid and forceful exhalation following deep inspiration.
Measured: 10 minutes
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory volume in the first second (FEV1). Forced vital capacity is the volume of air removed in the first second from the start of the maneuver.
Measured: 10 minutes
Pulmonary Function Test (FEV1/FVC)
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses FEV1/FVC.
Measured: 10 minutes
Pulmonary Function Test (peak flow rate (PEF))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses peak flow rate (PEF). PEF is measured by maximal inspiration followed by maximal exhalation maneuver.
Measured: 10 minutes
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
Testing procedures is in accordance with the guidelines published by ATS/ERS. A portable spirometer is used for assessment. Pulmonary function testing assesses forced expiratory flow from 25-75% (FEF25-75%). FEF25-75% mean flow rate at 50% of the forced vital capacity maneuver.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start18 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Kumlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682832
- Sponsor's protocol ID
- HU-FTR-KUMLUE-01
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exercise Capacity, Muscle Strength and Oxygenation, Arterial Stiffness, Physical Activity and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease and Impaired Spirometry With Preserved Ratio
- ClinicalTrials.gov ID
- NCT06682832
- Acronym / sponsor ID
- HU-FTR-KUMLUE-01
- Keywords
- COPD, PRISm, exercise capacity, muscle strength, arterial stiffness, physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Nov 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.
Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. As research continues to evolve, PRISm needs to be recognized as a critical component of pulmonary assessments and at-risk individuals need to be provided with appropriate treatment and follow-up to prevent progression to COPD. There are no studies in the literature comparing PRISm, respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in COPD and healthy individuals. The aim of this study was to compare respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy subjects.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable multisystemic lung disease characterised by chronic respiratory symptoms (dyspnoea, cough, expectoration and/or exacerbations) due to abnormalities in the airways causing permanent and often progressive airflow limitation. In a part of the individuals with affected lung function, FEV1/FVC is preserved after bronchodilation (≥ 70%), whereas FEV1 is lower than expected (< 80%). This condition, which describes a preserved ratio impaired spirometry (PRISm), is highly prevalent in current and former smokers. PRISm is defined as a spirometry pattern that is not always a stable phenotype, but should be considered ''patient'' because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. There are studies showing that pulmonary functions, exercise capacity and quality of life are impaired in individuals with PRISm, whose pathophysiology is unclear and clinical effects are not known. In addition to the insufficient number of studies investigating exercise capacity, quality of life and pulmonary function on behalf of PRISm in the literature, no previous studies comparing respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy individuals have been found. In this study, aimed to investigate whether the parameters (symptoms, respiratory and peripheral muscle strength, physical activity level, exercise capacity, muscle oxygenation, arterial stiffness), which have been proven to be affected in the COPD group due to their clinical similarity with COPD, are affected in the PRISm group. A total of 54 individuals, 18 in each group, will be included in the study. Pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life will be compared in PRISm, COPD and healthy individuals. Our study will be able to reveal the clinical status of PRISM patients in terms of pulmonary function, symptoms, body composition, respiratory muscle strength, peripheral muscle strength, exercise capacity, tissue oxygenation, arterial stiffness, physical activity levels, sleep and quality of life compared to COPD group and healthy group and will be a guide in planning pulmonary rehabilitation programmes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –Consisted of 18 individuals over 40 years of age with chronic obstructive pulmonary disease. |
| PRISm group | – | –Consisted of 18 individuals over 40 years of age with preserved ratio impaired spirometry. |
| Healthy group | – | –Consisted of 18 healthy individuals over 40 years of age. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD and PRISm patients referred to the Cardiopulmonary Rehabilitation Unit for routine physiotherapy and rehabilitation will be included in the study. The group of healthy individuals will be formed by including the healthy siblings of the participants who are age and gender compatible with the COPD and PRISm groups, and the volunteers among the relatives and acquaintances of the researchers. 54 individuals will be included in the study.
Key inclusion criteria (14 listed)
- PRISm group inclusion criteria;
- Being >40 years old,
- Being diagnosed with PRISm,
- Volunteering to participate in the study,
- Not having any orthopaedic or neurological problems that may prevent participation in the measurements,
Key exclusion criteria (10 listed)
- PRISm group exclusion criteria;
- Being diagnosed with COPD,
- Severe orthopaedic, neurological and cardiac diseases
- Not volunteering to participate in the study
- Severe orthopaedic, neurological and cardiac diseases,
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
Exercise capacity
Time frame: 6 minutes
Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.
Arterial Stiffness
Time frame: 20 minutes
Arterial stiffness is evaluated with a Tel-O-Graph CT device with oscillometric cuff (I.E.M., Stolberg, Germany). Central systolic blood pressure, pulse wave velocity (PWV) and augmentation index (Alx) are measured with brachial pulse waves. After a five-minute rest, three measurements are performed in a quiet environment.
Muscle Oxygenation
Time frame: 10 minutes
Muscle oxygenation is assessed using a measurement and monitoring device (Moxy Fortiori Design LLC, Minnesota, USA). The device is placed on the vastus lateralis muscle. Resting measurements are taken for at least 3 minutes until the muscle oxygen saturation (SmO2) signal stabilizes. SmO2 at rest, SmO2 during 6DYT and during the first minute of recovery, and mean SmO2 are recorded.
Physical Activity
Time frame: 5 minutes
Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week. Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity. The results for all activity-based items are summed for the total physical activity score. The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.
12 secondary outcomes
Body Composition
Time frame: 5 minutes
Respiratory Muscle Strength
Time frame: 10 minutes
Peripheral Muscle Strength
Time frame: 5 minutes
Sleep Quality
Time frame: 5 minutes
COPD Assessment Test
Time frame: 5 minutes
Quality of Life
Time frame: 10 minutes
Symptoms
Time frame: 8 minutes
Pulmonary Function Test (forced vital capacity (FVC))
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
Time frame: 10 minutes
Pulmonary Function Test (FEV1/FVC)
Time frame: 10 minutes
Pulmonary Function Test (peak flow rate (PEF))
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
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 Chronic Obstructive Pulmonary Disease (COPD) and Preserved Ratio Impaired Spirometry (PRISM), run by Hacettepe 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 14 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 31 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Kumlu, M.Sc (+90-312-305 2525 ext 178, eekumlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 6 minutes). The study lists 4 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 31 Mar 2026.