Comparing breathing, muscle, activity, and sleep measures in adults with COPD, PRISm, and healthy people

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

This project tries to see if breathing and limb muscle strength, oxygen levels, artery stiffness, physical activity and sleep differ between adults over 40 with PRISm, adults with stable COPD, and healthy adults.

Quick facts

• Study type: Observational
• Enrollment: 54 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Hacettepe University (Academic / other)
• Locations: 1 site (Ankara)
• Trial ID: NCT06682832 on ClinicalTrials.gov

What this trial studies

This observational comparison will enroll three groups of adults over 40—those with PRISm, those with clinically stable COPD, and healthy controls—and measure respiratory muscle strength, peripheral muscle strength, oxygenation, arterial stiffness, physical activity, and sleep. Participants will be recruited at Hacettepe University and undergo spirometry to confirm group status along with standardized strength tests, oxygen saturation monitoring, arterial stiffness assessment, and activity/sleep monitoring or questionnaires. People with severe orthopedic, neurological, or cardiac disease or recent COPD exacerbations are excluded to protect safety and data consistency. The goal is to describe functional and cardiovascular differences between PRISm and COPD that could guide follow-up and care.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 who can cooperate with testing and either have confirmed PRISm, clinically stable COPD, or no known chronic health problems (healthy controls).

Not a fit: Patients under 40, those with severe orthopedic, neurological, or cardiac conditions, or people currently in a COPD exacerbation are unlikely to be eligible or to gain direct benefit from participation.

Why it matters

Potential benefit: If the findings show clear differences, clinicians may better identify PRISm patients who need closer follow-up or targeted interventions to prevent progression to COPD.

How similar studies have performed: Prior work has reported impaired lung function, exercise capacity, and quality of life in PRISm, but no published studies have directly compared respiratory and peripheral muscle strength, oxygenation, arterial stiffness, activity and sleep across PRISm, COPD and healthy groups.

Eligibility criteria

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

Where this trial is running

Ankara

• Hacettepe University — Ankara, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Ece Kumlu, M.Sc

Conditions Chronic Obstructive Pulmonary Disease; Preserved Ratio Impaired Spirometry; COPD; PRISm; exercise capacity; muscle strength; arterial stiffness; physical activity