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

Sponsor
Universidade Estadual de Londrina (Other)
Overall Status
Recruiting
CT.gov ID
NCT03400839
Collaborator
Universidade Norte do Paraná (Other)
105
1
72.5
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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: Symptoms - UCSD/SOBQ
  • Diagnostic Test: HRQoL - SF36
  • Diagnostic Test: Anxiety and depression
  • Diagnostic Test: Symptoms - mMRC
  • Diagnostic Test: Sleep quality
  • Diagnostic Test: Sleepiness
  • Diagnostic Test: Inflammatory markers and oxidative stress
  • Diagnostic Test: Functional performance tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
Actual Study Start Date :
Sep 15, 2017
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

  1. 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidade Estadual de Londrina Londrina Paraná Brazil 86038-350

Sponsors and Collaborators

  • Universidade Estadual de Londrina
  • Universidade Norte do Paraná

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:
NCT03400839
Other Study ID Numbers:
  • 2.143.496
First Posted:
Jan 17, 2018
Last Update Posted:
Aug 2, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidade Estadual de Londrina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021