Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases

Universidade Estadual de Londrina1 site in 1 country105 target enrollmentSeptember 15, 2017

ConditionsInterstitial Lung Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Interstitial Lung Disease
Sponsor: Universidade Estadual de Londrina
Enrollment: 105
Locations: 1
Primary Endpoint: Changes of daily steps over time
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2017

End Date

October 1, 2023

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Universidade Estadual de Londrina

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•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;

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Changes of daily steps over time

Time Frame: 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.