Interstitial Lung Disease
Conditions
Keywords
Interstitial Lung disease, prognosis, clinical endpoints, association
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.
Interventions
DIAGNOSTIC_TESTDaily physical activity levels
Objectively measured physical activity using activity monitors.
DIAGNOSTIC_TEST6-minute walk test
Assessment of functional exercise capacity.
DIAGNOSTIC_TESTCardiopulmonary exercise testing
Assessment of maximal exercise capacity.
DIAGNOSTIC_TESTMuscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
DIAGNOSTIC_TESTLung Function
Assessment of whole-body plethysmography and spirometry.
DIAGNOSTIC_TESTBody composition
Assessment of bioelectrical impedance.
DIAGNOSTIC_TESTHRQoL - SGRQ-I
Assessment of Health-related quality of life by the Saint-George Respiratory questionnaire (SGRQ-I)
DIAGNOSTIC_TESTSymptoms - UCSD/SOBQ
Assessment of symptoms by the UCSD Short of breath questionnaire
DIAGNOSTIC_TESTHRQoL - SF36
Assessment of Health-related quality of life by the SF-36 questionnaire
DIAGNOSTIC_TESTAnxiety and depression
Assessment of anxiety and depression by the Hospital Anxiety And Depression (HADS) Scale
DIAGNOSTIC_TESTSymptoms - mMRC
Assessment of symptoms by the modified Medical Research Council (mMRC) scale
DIAGNOSTIC_TESTSleep quality
Assessment of sleep by the Pitsburg Sleep Quality Index (PSQI)
DIAGNOSTIC_TESTSleepiness
Assessment of sleepiness by the Epworth Sleepiness Scale
DIAGNOSTIC_TESTInflammatory 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_TESTFunctional 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).
Sponsors
Universidade Norte do Paraná
Universidade Estadual de Londrina
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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; 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactCarlos A Camillo, PT, PhD
Backup ContactFabio Pitta, PT, PhD
Outcome results
None listed