跳至主要内容
临床试验/NCT07004595
NCT07004595招募中不适用

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

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 12 months

association between the classifications "non-frail," "frail" (according to the Fried score- percentage of patients), "sarcopenic" (based on EWGSOP criteria - percebntage of patients), and "frail and sarcopenic" at the initial evaluation of ILD (percentage of patients)

to analyze the progression of sarcopenia

时间窗: up to 12 months

composite outcome comprising death, hospitalization, or progression of fibrosing ILD (percentage of patients)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验