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

ConditionSarcopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Evaluation of patient frailty

    Other intervention

    Quality of Life questionnaire

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months
2

to analyze the progression of sarcopenia

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

Time frame
up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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