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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 40 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03400839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universidade Estadual de Londrina
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Carlos A Camillo, PT, PhD
Principal Investigator Affiliation Universidade Estadual de Londrina
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Arms & Interventions

Arms

: Patients with ILD

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

: Control Group

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

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universidade Estadual de Londrina, Londrina, Paraná, Brazil

Status

Recruiting

Address

Universidade Estadual de Londrina

Londrina, Paraná, 86038-350

Site Contact

Carlos A Camillo, PT, PhD

carlos.a.camillo@outlook.com

+554333712490