Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07249567
Enrollment
60
Registered
2025-11-25
Start date
2025-10-05
Completion date
2026-11-30
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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

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.

Interventions

None listed

Sponsors

Karabuk University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical symptomsBaselineThe 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.
Peripheral muscle strengthBaselinePeripheral muscle strength will be evaluated with a dynamometer.
Muscle oxygenationBaselineMuscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Respiratory Muscle StrengthBaselineMaximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.
Respiratory Muscle EnduranceBaselineRespiratory 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.
DyspneaBaselineDyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.
Upper extremity exercise capacityBaselineUpper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Lower extremity exercise capacityBaselineLower extremity exercise capacity will be evaluated with six- minute walking test.

Secondary

MeasureTime frameDescription
Pulmonary function (Forced expiratory volume in the first second (FEV1)BaselinePulmonary 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.
Pulmonary function (FEV1 / FVC)BaselinePulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))BaselinePulmonary 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.
Pulmonary function (Peak flow rate (PEF))BaselinePulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Pulmonary function (Forced vital capacity (FVC)BaselinePulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMusa Güneş, PhD
musagunes52@hotmail.com03704789081

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026