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Recruiting NCT07249567

Comparison of Patients With COPD and PRISM

— Observational COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Respiratory and Peripheral Muscle Strength, Exercise Capacity, and Muscle Oxygenation in Individuals With COPD and PRISM

Overview

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.

Primary outcome measures

  • Upper extremity exercise capacity [Time frame: Baseline]
  • Lower extremity exercise capacity [Time frame: Baseline]
  • Peripheral muscle strength [Time frame: Baseline]
  • Muscle oxygenation [Time frame: Baseline]
  • Respiratory Muscle Strength [Time frame: Baseline]
  • Respiratory Muscle Endurance [Time frame: Baseline]
  • Dyspnea [Time frame: Baseline]
  • Clinical symptoms [Time frame: Baseline]
Secondary outcome measures (5)
  • Pulmonary function (Forced vital capacity (FVC) [Time frame: Baseline]
  • Pulmonary function (Forced expiratory volume in the first second (FEV1) [Time frame: Baseline]
  • Pulmonary function (FEV1 / FVC) [Time frame: Baseline]
  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) [Time frame: Baseline]
  • Pulmonary function (Peak flow rate (PEF)) [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Karabuk University, Physiotherapy and Rehabilitation Application and Research Center — Karabük

Identifiers

NCT: NCT07249567 · Karabuk-2383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗