RecruitingNot Applicable

Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry

Turkey (Türkiye)54 participantsStarted 2025-09-18

Plain-language 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. 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Inclusion criteria for the COPD group; * Being \>40 years old, * Being diagnosed with COPD, * To be clinically stable, * Volunteering to participate in the study. Inclusion criteria for healthy individuals; * Being \>40 years old, * Volunteering to participate in the study, * No known chronic health problems, * To be able to co-operate with the measurements. Exclusion Criteria: PRISm group exclusion criteria; * Being diagnosed with COPD, * Severe orthopaedic, neurological and cardiac diseases * Not volunteering to participate in the study Exclusion criteria for COPD group; * Severe orthopaedic, neurological and cardiac diseases, * Being in COPD exacerbation period, * Not volunteering to participate in the study. Healthy individuals exclusion criteria; * Having a known chronic disease, * Not volunteering to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exercise capacity

Timeframe: 6 minutes

Arterial Stiffness

Timeframe: 20 minutes

Muscle Oxygenation

Timeframe: 10 minutes

Physical Activity

Timeframe: 5 minutes

Trial details

NCT IDNCT06682832

SponsorHacettepe University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

Contact for this trial

Ece Kumlu, M.Sc

+90-312-305 2525 ext 178 eekumlu@gmail.com

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease (COPD) trials