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

NCT07004595 | Not Yet Recruiting

• 1 other identifier: AP_CM_001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia

Keywords

Fibrosing interstitial lung diseases;; frailty; sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  12 months

• to analyze the progression of sarcopenia

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

  up to 12 months

Interventions

Evaluation of patient frailty OTHER

Quality of Life questionnaire

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of older adults who are incident cases of patients referred to Nantes University Hospital for the evaluation of fibrosing ILD

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: June 4, 2025
• Study Start: July 20, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): December 20, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share