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

Study Overview
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Brief Summary
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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.

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

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ILD<br>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<br>* Objectively measured physical activity using activity monitors.<br>Diagnostic Test: 6-minute walk test<br>* Assessment of functional exercise capacity.<br>Diagnostic Test: Cardiopulmonary exercise testing<br>* Assessment of maximal exercise capacity.<br>Diagnostic Test: Muscle Function<br>* Assessment of muscle force, muscle endurance and muscle fatigability<br>Diagnostic Test: Lung Function<br>* Assessment of whole-body plethysmography and spirometry.<br>Diagnostic Test: Body composition<br>* Assessment of bioelectrical impedance.<br>Diagnostic Test: HRQoL - SGRQ-I<br>* Assessment of Health-related quality of life by the Saint-George Respiratory questionnaire (SGRQ-I)<br>Diagnostic Test: Symptoms - UCSD/SOBQ<br>* Assessment of symptoms by the UCSD Short of breath questionnaire<br>Diagnostic Test: HRQoL - SF36<br>* Assessment of Health-related quality of life by the SF-36 questionnaire<br>Diagnostic Test: Anxiety and depression<br>* Assessment of anxiety and depression by the Hospital Anxiety And Depression (HADS) Scale<br>Diagnostic Test: Symptoms - mMRC<br>* Assessment of symptoms by the modified Medical Research Council (mMRC) scale<br>Diagnostic Test: Sleep quality<br>* Assessment of sleep by the Pitsburg Sleep Quality Index (PSQI)<br>Diagnostic Test: Sleepiness<br>* Assessment of sleepiness by the Epworth Sleepiness Scale<br>Diagnostic Test: Inflammatory markers and oxidative stress<br>* 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.<br>Diagnostic Test: Functional performance tests<br>* 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).<br>|
| Control Group<br>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<br>* Objectively measured physical activity using activity monitors.<br>Diagnostic Test: 6-minute walk test<br>* Assessment of functional exercise capacity.<br>Diagnostic Test: Cardiopulmonary exercise testing<br>* Assessment of maximal exercise capacity.<br>Diagnostic Test: Muscle Function<br>* Assessment of muscle force, muscle endurance and muscle fatigability<br>Diagnostic Test: Lung Function<br>* Assessment of whole-body plethysmography and spirometry.<br>Diagnostic Test: Body composition<br>* Assessment of bioelectrical impedance.<br>Diagnostic Test: HRQoL - SF36<br>* Assessment of Health-related quality of life by the SF-36 questionnaire<br>Diagnostic Test: Anxiety and depression<br>* Assessment of anxiety and depression by the Hospital Anxiety And Depression (HADS) Scale<br>Diagnostic Test: Sleep quality<br>* Assessment of sleep by the Pitsburg Sleep Quality Index (PSQI)<br>Diagnostic Test: Sleepiness<br>* Assessment of sleepiness by the Epworth Sleepiness Scale<br>Diagnostic Test: Inflammatory markers and oxidative stress<br>* 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.<br>Diagnostic Test: Functional performance tests<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial Lung disease, prognosis, clinical endpoints, association