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Идёт набор NCT07004595

Evaluation of Frailty in Patients With Fibrosing Interstitial Lung Diseases: Prognostic and Therapeutic Impact

Наблюдательное Sarcopenia

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
В протоколе указаны: Evaluation of patient frailty.
Кому может быть актуально
Состояния в реестре: Sarcopenia. Базовые параметры: от 65 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
Франция
Следующий шаг
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Обзор

Fibrosing interstitial lung diseases (ILDs), with idiopathic pulmonary fibrosis being the most common form, primarily affect older individuals and have a poor prognosis, with a median survival of 3 to 5 years. While antifibrotic treatments such as nintedanib and pirfenidone can slow disease progression, their efficacy is often limited by side effects, particularly in elderly patients. A comprehensive patient assessment, including evaluations of frailty and sarcopenia, could optimize care by identifying those at risk for poor outcomes or poor treatment tolerance. Frailty, characterized by reduced physiological reserves, and sarcopenia, defined as a loss of muscle mass and strength, are both associated with increased mortality and morbidity risks. Although their individual impacts on fibrosing ILDs have been documented, the combined effect of these two syndromes on patient prognosis remains unexplored, highlighting the need for further studies to guide therapeutic decision-making.

Подробное описание

Frailty and sarcopenia are two distinct entities, each capable of worsening patient mortality and morbidity. Their association has been studied in the general population in a cohort of over 2,000 individuals aged 70 to 85 years (34816568). The prevalence of sarcopenia among frail participants was 40%. The characteristics and risks faced by patients who were both frail and sarcopenic differed from those who were only sarcopenic or only frail.

No study has evaluated the prognostic impact of the combined presence of sarcopenia and frailty on the outcomes of patients with fibrosing ILDs.

Вмешательства

  • Другое Evaluation of patient frailty
    Quality of Life questionnaire

Первичные конечные точки

  • to analyze the prognostic value of the phenotypes "frail and sarcopenic," "frail only," "sarcopenic only," and "robust" on the outcomes of patients with fibrosing ILDs [Срок оценки: 12 months]
  • to analyze the progression of sarcopenia [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

  • Patient with fibrosing ILD according to the ATS/ERS/JRS/ALAT 2022 criteria.
  • Patient aged ≥ 65 years.
  • Outpatient consultation (scheduled appointment in an outpatient clinic, day hospital, or weekly hospital stay).
  • French-speaking patient.
  • Patient who has received an information sheet explaining the study and has not expressed opposition to participating in this research.

Критерии исключения

  • Patient under legal guardianship, curatorship, or judicial protection.
  • Cognitive disorders limiting the use of questionnaires.
  • Patient with a CT scan showing an early usual interstitial pneumonia (UIP) pattern according to the ATS/ERS/JRS/ALAT 2022 classification.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 1 центр
  • CHU Nantes - Respiratory Department — Nantes

Идентификаторы

NCT: NCT07004595 · AP_CM_001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗