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

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

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Daily physical activity levels

Objectively measured physical activity using activity monitors.

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6-minute walk test

Assessment of functional exercise capacity.

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Cardiopulmonary exercise testing

Assessment of maximal exercise capacity.

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Muscle Function

Assessment of muscle force, muscle endurance and muscle fatigability

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Lung Function

Assessment of whole-body plethysmography and spirometry.

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Body composition

Assessment of bioelectrical impedance.

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HRQoL - SGRQ-I

Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"

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Symptoms - UCSD/SOBQ

Assessment of symptoms by the "UCSD Short of breath questionnaire"

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HRQoL - SF36

Assessment of Health-related quality of life by the "SF-36 questionnaire"

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Anxiety and depression

Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"

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Symptoms - mMRC

Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"

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Sleep quality

Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"

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Sleepiness

Assessment of sleepiness by the "Epworth Sleepiness Scale"

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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.

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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).

Sponsors & Collaborators

• Universidade Norte do Paraná

  collaborator OTHER

• Universidade Estadual de Londrina

  lead OTHER

Principal Investigators

• Carlos A Camillo, PT, PhD · Universidade Estadual de Londrina

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-15

Primary Completion

2023-10-01

Completion

2023-10-01

Countries

• Brazil

Study Locations