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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual de Londrina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidade Norte do Paraná

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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