Comparison of Patients With COPD and PRISM

NCT ID: NCT07249567

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-05

Study Completion Date

2026-11-30

Brief Summary

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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

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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

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with COPD

Patients with chronic obstructive pulmonary disease will be included.

No interventions assigned to this group

Patients with PRISm

Patients with preserved ratio impaired spirometry will be included.

No interventions assigned to this group

Control

Healthy controls will be included.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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:

* 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.

Exclusion Criteria

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.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk University

OTHER

Sponsor Role lead

Responsible Party

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Musa Güneş

Principal Investigator, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musa Güneş, PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Rabia Hande Avcı, MD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Locations

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Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Musa Güneş, PhD

Role: CONTACT

03704789081

Facility Contacts

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Musa Güneş, MsC

Role: primary

03704189081

Other Identifiers

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Karabuk-2383

Identifier Type: -

Identifier Source: org_study_id

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