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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07004595
Acronym
FRAPID
Enrollment
100
Registered
2025-06-04
Start date
2025-07-20
Completion date
2027-12-20
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Fibrosing interstitial lung diseases;, frailty, sarcopenia

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.

Detailed description

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.

Interventions

OTHEREvaluation of patient frailty

Quality of Life questionnaire

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
to analyze the prognostic value of the phenotypes "frail and sarcopenic," "frail only," "sarcopenic only," and "robust" on the outcomes of patients with fibrosing ILDs12 monthsassociation 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 sarcopeniaup to 12 monthscomposite outcome comprising death, hospitalization, or progression of fibrosing ILD (percentage of patients)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026