NCT03400839

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Universidade Estadual de Londrina · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Interstitial Lung Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-09-15
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2018-01-17
• Last updated: 2021-08-02

Locations

1 site across 1 country: Brazil