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Идёт набор NCT07249567

Comparison of Patients With COPD and PRISM

— Наблюдательное COPD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: COPD. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

NCT: NCT07249567 · Karabuk-2383

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗