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Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases (BELIEVE-ILD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400839
Recruitment Status : Unknown
Verified January 2018 by Universidade Estadual de Londrina.
Recruitment status was:  Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Universidade Norte do Paraná
Information provided by (Responsible Party):
Universidade Estadual de Londrina

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.

Condition or disease Intervention/treatment
Interstitial Lung Disease 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

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.


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.
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 - 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: 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.





Primary Outcome Measures :
  1. Changes of daily steps over time [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Clinical and biological data collected in the study may be used in other investigations upon participants written consent


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400839


Contacts
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Contact: Carlos A Camillo, PT, PhD +554333712490 carlos.a.camillo@outlook.com
Contact: Fabio Pitta, PT, PhD +554333712477 fabio.pitta@uol.com.br

Locations
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Brazil
Universidade Estadual de Londrina Recruiting
Londrina, Paraná, Brazil, 86038-350
Contact: Carlos A Camillo, PT, PhD    +554333712490    carlos.a.camillo@outlook.com   
Contact: Fabio Pitta, PT, PhD    +554333712477    fabio.pitta@uol.com.br   
Sub-Investigator: Humberto Silva, PT, MSc         
Sub-Investigator: Wagner F Aguiar, PT, MSc         
Principal Investigator: Marcos Ribeiro, MD, PhD         
Principal Investigator: Fabio Pitta, PT, PhD         
Principal Investigator: Carlos A Camillo, PT, PhD         
Sponsors and Collaborators
Universidade Estadual de Londrina
Universidade Norte do Paraná
Investigators
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Principal Investigator: Carlos A Camillo, PT, PhD Universidade Estadual de Londrina
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Responsible Party: Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT03400839    
Other Study ID Numbers: 2.143.496
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data collected may be used in other studies upon participants' written consent. However, it is not the intention of investigators to share the data publically (In exception of final results of the study after completion)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade Estadual de Londrina:
Interstitial Lung disease
prognosis
clinical endpoints
association
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases