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Comparison of Patients With COPD and PRISM

ConditionCOPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorKarabuk University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being >40 years old,

Being diagnosed with COPD,

Being clinically stable,

Volunteering to participate in the study.

Disqualifiers

Having severe orthopedic, neurological, or cardiac diseases,

Being in a COPD exacerbation,

Having a comorbid lung disease,

Being on clinically unstable medication,

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Patients with COPD
Group B: Patients with PRISm
Group C: Control

Trial outcomes

Primary outcomes

1

Upper extremity exercise capacity

Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).

Time frame
Baseline
2

Lower extremity exercise capacity

Lower extremity exercise capacity will be evaluated with six- minute walking test.

Time frame
Baseline
3

Peripheral muscle strength

Peripheral muscle strength will be evaluated with a dynamometer.

Time frame
Baseline
4

Muscle oxygenation

Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).

Time frame
Baseline

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karabuk University

Lead sponsor

Source ClinicalTrials.gov
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