Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases (BELIEVE-ILD)

Universidade Estadual de Londrina

Status

Unknown

Conditions

Interstitial Lung Disease

Treatments

Diagnostic Test: Sleepiness

Diagnostic Test: Sleep quality

Diagnostic Test: Anxiety and depression

Diagnostic Test: HRQoL - SGRQ-I

Diagnostic Test: 6-minute walk test

Diagnostic Test: Inflammatory markers and oxidative stress

Diagnostic Test: HRQoL - SF36

Diagnostic Test: Daily physical activity levels

Diagnostic Test: Cardiopulmonary exercise testing

Diagnostic Test: Functional performance tests

Diagnostic Test: Symptoms - mMRC

Diagnostic Test: Lung Function

Diagnostic Test: Symptoms - UCSD/SOBQ

Diagnostic Test: Body composition

Diagnostic Test: Muscle Function

Study type

Observational

Funder types

Other

Identifiers

NCT03400839

2.143.496

Details and patient eligibility

About

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.

Enrollment

105 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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;
Participants with cognitive deficit that interfere with any of the tests;

Trial design

105 participants in 2 patient groups

Patients with ILD

Description:

Patients with a medical diagnosis of interstitial lung disease. Patients will be submitted to the assessment of: * Daily physical activity levels; * 6-minute walk test; * Cardiopulmonary exercise testing; * Muscle Function; * Lung Function; * Body composition; * HRQoL - SGRQ-I; * HRQoL - SF36; * Anxiety and depression; * Symptoms - mMRC * Symptoms - UCSD/SOBQ; * Sleep quality; * Sleepiness; * Inflammatory markers and oxidative stress. * Functional performance tests

Treatment:

Diagnostic Test: Cardiopulmonary exercise testing

Diagnostic Test: Body composition

Diagnostic Test: Symptoms - UCSD/SOBQ

Diagnostic Test: Inflammatory markers and oxidative stress

Diagnostic Test: Sleepiness

Diagnostic Test: Sleep quality

Diagnostic Test: Anxiety and depression

Diagnostic Test: 6-minute walk test

Diagnostic Test: Symptoms - mMRC

Diagnostic Test: HRQoL - SGRQ-I

Diagnostic Test: Lung Function

Diagnostic Test: Muscle Function

Diagnostic Test: Daily physical activity levels

Diagnostic Test: HRQoL - SF36

Diagnostic Test: Functional performance tests

Control Group

Description:

Age-matched peers without lung diseases. Participants will be submitted to the assessment of: * Daily physical activity levels; * 6-minute walk test; * Cardiopulmonary exercise testing; * Muscle Function; * Lung Function; * Body composition; * HRQoL - SF36; * Anxiety and depression; * Sleep quality; * Sleepiness; * Inflammatory markers and oxidative stress. * Functional performance tests

Treatment:

Diagnostic Test: Cardiopulmonary exercise testing

Diagnostic Test: Body composition

Diagnostic Test: Inflammatory markers and oxidative stress

Diagnostic Test: Sleepiness

Diagnostic Test: Sleep quality

Diagnostic Test: Anxiety and depression

Diagnostic Test: 6-minute walk test

Diagnostic Test: Lung Function

Diagnostic Test: Muscle Function

Diagnostic Test: Daily physical activity levels

Diagnostic Test: HRQoL - SF36