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

Interstitial Lung Disease Clinical Trial

— BELIEVE-ILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400839
• Other study ID #: 2.143.496
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2020
• Source: Universidade Estadual de Londrina
• Contact: Carlos A Camillo, PT, PhD
• Phone: +554333712490
• Email: carlos.a.camillo[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Diagnostic Test:
• Daily physical activity levels
Objectively measured physical activity using activity monitors.
• 6-minute walk test
Assessment of functional exercise capacity.
• Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
• Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
• Lung Function
Assessment of whole-body plethysmography and spirometry.
• Body composition
Assessment of bioelectrical impedance.
• HRQoL - SGRQ-I
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
• Symptoms - UCSD/SOBQ
Assessment of symptoms by the "UCSD Short of breath questionnaire"
• HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
• Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
• Symptoms - mMRC
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
• Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
• Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
• Inflammatory markers and oxidative stress
blood assessment of inflammatory markers: IL-2, IL-10, IL-6, IL-4 e IL-17A, TNF, Interferon-?, CK and CRP. Blood assessment of oxidative stress: TRAP, SH, SOD, CAT, PON 1, Gpx, MDA, NOx, FOX and AOPP.
• 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).

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Londrina	Londrina	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina	Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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