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

• Conditions: Interstitial Lung Disease
• Interventions: Diagnostic Test: Daily physical activity levels; Diagnostic Test: 6-minute walk test; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Muscle Function; Diagnostic Test: Lung Function; Diagnostic Test: Body composition; Diagnostic Test: HRQoL - SGRQ-I; Diagnostic Test: Anxiety and depression; Diagnostic Test: Symptoms - UCSD/SOBQ; Diagnostic Test: HRQoL - SF36; Diagnostic Test: Sleep quality; Diagnostic Test: Symptoms - mMRC; Diagnostic Test: Sleepiness; Diagnostic Test: Inflammatory markers and oxidative stress; Diagnostic Test: Functional performance tests

• 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

Arm && Interventions

Group	Intervention	Description
Patients with ILD	Daily physical activity levels	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
Patients with ILD	6-minute walk test	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
Patients with ILD	HRQoL - SF36	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
Patients with ILD	Symptoms - mMRC	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
Control Group	Lung Function	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
Control Group	Body composition	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
Control Group	Anxiety and depression	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
Patients with ILD	Cardiopulmonary exercise testing	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
Patients with ILD	Sleepiness	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
Control Group	Daily physical activity levels	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
Control Group	Muscle Function	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
Control Group	Sleepiness	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
Control Group	Sleep quality	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
Patients with ILD	Lung Function	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
Patients with ILD	HRQoL - SGRQ-I	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
Patients with ILD	Sleep quality	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
Patients with ILD	Inflammatory markers and oxidative stress	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
Control Group	Cardiopulmonary exercise testing	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
Control Group	Inflammatory markers and oxidative stress	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
Patients with ILD	Muscle Function	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
Patients with ILD	Body composition	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
Patients with ILD	Symptoms - UCSD/SOBQ	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
Patients with ILD	Anxiety and depression	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
Patients with ILD	Functional performance tests	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
Control Group	6-minute walk test	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
Control Group	HRQoL - SF36	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
Control Group	Functional performance tests	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

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