Comparison of Patients With COPD and PRISM

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.

Study Overview

• Status: Recruiting
• Conditions: COPD

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Musa Güneş, PhD; Phone Number: 03704789081; Email: musagunes52@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Karabük, Turkey (Türkiye)
    • Recruiting
    • Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
    • Contact: Musa Güneş, MsC; Phone Number: 03704189081; Email: musagunes@karabuk.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD and PRSIm will be included and compared with healthy controls

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity exercise capacity	Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).	Baseline
Lower extremity exercise capacity	Lower extremity exercise capacity will be evaluated with six- minute walking test.	Baseline
Peripheral muscle strength	Peripheral muscle strength will be evaluated with a dynamometer.	Baseline
Muscle oxygenation	Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).	Baseline
Respiratory Muscle Strength	Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.	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.	Baseline
Dyspnea	Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Karabuk University
• Investigators: Principal Investigator: Musa Güneş, PhD, Karabuk University; Principal Investigator: Rabia Hande Avcı, MD, Karabuk University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Karabuk-2383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No