Interstitial Lung DiseaseBELIEVE-ILDNCT03400839
Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
An observational study of Interstitial Lung Disease, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Daily physical activity levels, 6-minute walk test and Cardiopulmonary exercise testing
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2017to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual de Londrina
Londrina, Paraná, 86038-350
Carlos A Camillo, PT, PhD, +554333712490, carlos.a.camillo@outlook.com
Fabio Pitta, PT, PhD, +554333712477, fabio.pitta@uol.com.br
About this study
Official title: Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
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
- Being tested
- Daily physical activity levels, 6-minute walk test, Cardiopulmonary exercise testing, Muscle Function, Lung Function
- Keywords
- Interstitial Lung disease, prognosis, clinical endpoints, association
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily physical activity levelsDiagnostic test
Objectively measured physical activity using activity monitors.
6-minute walk testDiagnostic test
Assessment of functional exercise capacity.
Cardiopulmonary exercise testingDiagnostic test
Assessment of maximal exercise capacity.
Muscle FunctionDiagnostic test
Assessment of muscle force, muscle endurance and muscle fatigability
Lung FunctionDiagnostic test
Assessment of whole-body plethysmography and spirometry.
Body compositionDiagnostic test
Assessment of bioelectrical impedance.
HRQoL - SGRQ-IDiagnostic test
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Symptoms - UCSD/SOBQDiagnostic test
Assessment of symptoms by the "UCSD Short of breath questionnaire"
HRQoL - SF36Diagnostic test
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Anxiety and depressionDiagnostic test
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Symptoms - mMRCDiagnostic test
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Sleep qualityDiagnostic test
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
SleepinessDiagnostic test
Assessment of sleepiness by the "Epworth Sleepiness Scale"
Inflammatory markers and oxidative stressDiagnostic test
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.
Functional performance testsDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 | |
| 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 Receives: 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 - SF36; Diagnostic Test: Anxiety and depression; Diagnostic Test: Sleep quality; Diagnostic Test: Sleepiness; Diagnostic Test: Inflammatory markers and oxidative stress; Diagnostic Test: Functional performance tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start15 Sep 2017
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Norte do Paraná
- Responsible party
- Sponsor
- Investigators
- Carlos A Camillo, PT, PhD, Principal investigator, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400839
- Sponsor's protocol ID
- 2.143.496
- Acronym
- BELIEVE-ILD
- Status last verified
- Nov 2020
- First submitted
- 9 Jan 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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)
Publications
Garcia T, Mantoani LC, Silva H, Zamboti CL, Ribeiro M, Ramos EMC, Pitta F, Camillo CA. Characteristics of Skeletal Muscle Strength in Subjects With Interstitial Lung Disease. Arch Phys Med Rehabil. 2024 Jun;105(6):1099-1105. doi: 10.1016/j.apmr.2024.01.006. Epub 2024 Jan 24.
PubMed 38272247
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Impact of Clinical Outcomes on Disease Progression and Prognosis in Patients With Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT03400839
- Acronym / sponsor ID
- BELIEVE-ILD / 2.143.496
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial Lung disease, prognosis, clinical endpoints, association
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Collaborators
- Universidade Norte do Paraná
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ILD | – | 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 testsPatients 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 | – | 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 - SF36, Diagnostic Test: Anxiety and depression, Diagnostic Test: Sleep quality, Diagnostic Test: Sleepiness, Diagnostic Test: Inflammatory markers and oxidative stress, Diagnostic Test: Functional performance testsAge-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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.
Key inclusion criteria (8 listed)
- Patients with interstitial lung disease:
- Age-matched control group:
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily physical activity levelsObjectively measured physical activity using activity monitors. | Diagnostic test | Control Group, Patients with ILD |
| 6-minute walk testAssessment of functional exercise capacity. | Diagnostic test | Control Group, Patients with ILD |
| Cardiopulmonary exercise testingAssessment of maximal exercise capacity. | Diagnostic test | Control Group, Patients with ILD |
| Muscle FunctionAssessment of muscle force, muscle endurance and muscle fatigability | Diagnostic test | Control Group, Patients with ILD |
| Lung FunctionAssessment of whole-body plethysmography and spirometry. | Diagnostic test | Control Group, Patients with ILD |
| Body compositionAssessment of bioelectrical impedance. | Diagnostic test | Control Group, Patients with ILD |
| HRQoL - SGRQ-IAssessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)" | Diagnostic test | Patients with ILD |
| Symptoms - UCSD/SOBQAssessment of symptoms by the "UCSD Short of breath questionnaire" | Diagnostic test | Patients with ILD |
| HRQoL - SF36Assessment of Health-related quality of life by the "SF-36 questionnaire" | Diagnostic test | Control Group, Patients with ILD |
| Anxiety and depressionAssessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale" | Diagnostic test | Control Group, Patients with ILD |
| Symptoms - mMRCAssessment of symptoms by the "modified Medical Research Council (mMRC) scale" | Diagnostic test | Patients with ILD |
| Sleep qualityAssessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)" | Diagnostic test | Control Group, Patients with ILD |
| SleepinessAssessment of sleepiness by the "Epworth Sleepiness Scale" | Diagnostic test | Control Group, Patients with ILD |
| Inflammatory markers and oxidative stressblood 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 | Control Group, Patients with ILD |
| Functional performance testsTimed-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). | Diagnostic test | Control Group, Patients with ILD |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 38272247Garcia T, Mantoani LC, Silva H, Zamboti CL, Ribeiro M, Ramos EMC, Pitta F, Camillo CA. Characteristics of Skeletal Muscle Strength in Subjects With Interstitial Lung Disease. Arch Phys Med Rehabil. 2024 Jun;105(6):1099-1105. doi: 10.1016/j.apmr.2024.01.006. Epub 2024 Jan 24.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Camillo, PT, PhD principal investigator
Universidade Estadual de Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Camillo, PT, PhD (+554333712490, carlos.a.camillo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.