An observational study in COPD, sponsored by Karabuk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Karabuk University · Observational
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 60 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Karabuk University is the lead sponsor of 126 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with COPD and PRSIm will be included and compared with healthy controls
For the COPD group:
For the PRISm group:
For the healthy control group:
Exclusion Criteria:
For the COPD group:
For the PRISm group:
For the healthy control group:
Patients with chronic obstructive pulmonary disease will be included.
Patients with preserved ratio impaired spirometry will be included.
Healthy controls will be included.
Upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Time frame: Baseline
Lower extremity exercise capacity
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Time frame: Baseline
Peripheral muscle strength
Peripheral muscle strength will be evaluated with a dynamometer.
Time frame: Baseline
Muscle oxygenation
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Time frame: Baseline
Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.
Time frame: 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.
Time frame: Baseline
Dyspnea
Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.
Time frame: 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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Plan to share: No
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Karabuk University