Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
BELIEVE-ILD
Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
1 other identifier
observational
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedAugust 2, 2021
November 1, 2020
6 years
January 9, 2018
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of daily steps over time
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
Study Arms (2)
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
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
Interventions
Objectively measured physical activity using activity monitors.
Assessment of functional exercise capacity.
Assessment of maximal exercise capacity.
Assessment of muscle force, muscle endurance and muscle fatigability
Assessment of whole-body plethysmography and spirometry.
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Assessment of symptoms by the "UCSD Short of breath questionnaire"
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Assessment of sleepiness by the "Epworth Sleepiness Scale"
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.
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).
Eligibility Criteria
A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.
You may qualify if:
- Patients with interstitial lung disease:
- Diagnosis of interstitial lung disease;
- Absence of any comorbidity that interferes with the performance of tests;
- Age-matched control group:
- Absence of any comorbidity that interferes with the performance of tests;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Estadual de Londrinalead
- Universidade Norte do Paranácollaborator
Study Sites (1)
Universidade Estadual de Londrina
Londrina, Paraná, 86038-350, Brazil
Related Publications (1)
Garcia T, Mantoani LC, Silva H, Zamboti CL, Ribeiro M, Ramos EMC, Pitta F, Camillo CA. Characteristics of Skeletal Muscle Strength in Subjects With Interstitial Lung Disease. Arch Phys Med Rehabil. 2024 Jun;105(6):1099-1105. doi: 10.1016/j.apmr.2024.01.006. Epub 2024 Jan 24.
PMID: 38272247DERIVED
Biospecimen
Clinical and biological data collected in the study may be used in other investigations upon participants written consent
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos A Camillo, PT, PhD
Universidade Estadual de Londrina
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 17, 2018
Study Start
September 15, 2017
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
August 2, 2021
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
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)