Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases

• Conditions: Interstitial Lung Disease

• Registration Number: NCT03400839
• Lead Sponsor: Universidade Estadual de Londrina

Brief Summary

This prospective cohort study will investigate whether progression of the interstitial lung diseases is related to specific clinical endpoints and their changes over time. Longitudinal data of patients will be compared to an age-matched control group during a follow-up of at least two years.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Status Verified: 2020-11
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Patients with interstitial lung disease:

   • Age between 40 and 75 years old upon inclusion;
   • Diagnosis of interstitial lung disease;
   • Clinical stability for at least 4 weeks prior to inclusion;
   • Absence of any comorbidity that interferes with the performance of tests;

2. Age-matched control group:

   • Age between 40 and 75 years old upon inclusion;
   • Absence of any comorbidity that interferes with the performance of tests;

Exclusion Criteria (both groups):

• Participants that present severe or unstable cardiac disease identified during the cardiopulmonary exercise testing;
• Participants with cognitive deficit that interfere with any of the tests;

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of daily steps over time	from date of inclusion until the date of study completion or until the documented date of death from any cause, whichever came first, up to 48 months	Changes in daily steps (measured using an activity monitor) at every 6-month interval until study completion or end of participation in the study.

Trial Locations

Locations (1)

Universidade Estadual de Londrina; 🇧🇷 Londrina, Paraná, Brazil