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

July 26, 2021 updated by: Universidade Estadual de Londrina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Paraná
      • Londrina, Paraná, Brazil, 86038-350
        • Recruiting
        • Universidade Estadual de Londrina
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Humberto Silva, PT, MSc
        • Sub-Investigator:
          • Wagner F Aguiar, PT, MSc
        • Principal Investigator:
          • Marcos Ribeiro, MD, PhD
        • Principal Investigator:
          • Fabio Pitta, PT, PhD
        • Principal Investigator:
          • Carlos A Camillo, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ILD

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
Diagnostic test: Daily physical activity levels
Objectively measured physical activity using activity monitors.
Diagnostic test: 6-minute walk test
Assessment of functional exercise capacity.
Diagnostic test: Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Diagnostic test: Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Diagnostic test: Lung Function
Assessment of whole-body plethysmography and spirometry.
Diagnostic test: Body composition
Assessment of bioelectrical impedance.
Diagnostic test: HRQoL - SGRQ-I
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Diagnostic test: Symptoms - UCSD/SOBQ
Assessment of symptoms by the "UCSD Short of breath questionnaire"
Diagnostic test: HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Diagnostic test: Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Diagnostic test: Symptoms - mMRC
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Diagnostic test: Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Diagnostic test: Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
Diagnostic test: Inflammatory markers and oxidative stress

blood assessment of inflammatory markers: IL-2, IL-10, IL-6, IL-4 e IL-17A, TNF, Interferon-γ, CK and CRP.

Blood assessment of oxidative stress: TRAP, SH, SOD, CAT, PON 1, Gpx, MDA, NOx, FOX and AOPP.

Diagnostic test: Functional performance tests
Timed-up-and-go at usual pace (TUGu) and at a fast pace (TUGf), four-metre gait speed test (4MGS), sit-to-stand test using three protocols: 30 seconds (30sec-STS), one minute (1min-STS) and five-repetition (5rep-STS) and Short Physical Performance Balance (SPPB).
Control Group

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
Diagnostic test: Daily physical activity levels
Objectively measured physical activity using activity monitors.
Diagnostic test: 6-minute walk test
Assessment of functional exercise capacity.
Diagnostic test: Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Diagnostic test: Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Diagnostic test: Lung Function
Assessment of whole-body plethysmography and spirometry.
Diagnostic test: Body composition
Assessment of bioelectrical impedance.
Diagnostic test: HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Diagnostic test: Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Diagnostic test: Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Diagnostic test: Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
Diagnostic test: Inflammatory markers and oxidative stress

blood assessment of inflammatory markers: IL-2, IL-10, IL-6, IL-4 e IL-17A, TNF, Interferon-γ, CK and CRP.

Blood assessment of oxidative stress: TRAP, SH, SOD, CAT, PON 1, Gpx, MDA, NOx, FOX and AOPP.

Diagnostic test: Functional performance tests
Timed-up-and-go at usual pace (TUGu) and at a fast pace (TUGf), four-metre gait speed test (4MGS), sit-to-stand test using three protocols: 30 seconds (30sec-STS), one minute (1min-STS) and five-repetition (5rep-STS) and Short Physical Performance Balance (SPPB).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual de Londrina

Collaborators

Universidade Norte do Paraná

Investigators

  • Principal Investigator: Carlos A Camillo, PT, PhD, Universidade Estadual de Londrina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.143.496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected may be used in other studies upon participants' written consent. However, it is not the intention of investigators to share the data publically (In exception of final results of the study after completion)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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