Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
NCT ID: NCT03400839
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
105 participants
OBSERVATIONAL
2017-09-15
2023-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Daily physical activity levels
Objectively measured physical activity using activity monitors.
6-minute walk test
Assessment of functional exercise capacity.
Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Lung Function
Assessment of whole-body plethysmography and spirometry.
Body composition
Assessment of bioelectrical impedance.
HRQoL - SGRQ-I
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Symptoms - UCSD/SOBQ
Assessment of symptoms by the "UCSD Short of breath questionnaire"
HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Symptoms - mMRC
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
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.
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).
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
Daily physical activity levels
Objectively measured physical activity using activity monitors.
6-minute walk test
Assessment of functional exercise capacity.
Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Lung Function
Assessment of whole-body plethysmography and spirometry.
Body composition
Assessment of bioelectrical impedance.
HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
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.
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).
Interventions
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Daily physical activity levels
Objectively measured physical activity using activity monitors.
6-minute walk test
Assessment of functional exercise capacity.
Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Lung Function
Assessment of whole-body plethysmography and spirometry.
Body composition
Assessment of bioelectrical impedance.
HRQoL - SGRQ-I
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Symptoms - UCSD/SOBQ
Assessment of symptoms by the "UCSD Short of breath questionnaire"
HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Symptoms - mMRC
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Participants with cognitive deficit that interfere with any of the tests;
40 Years
75 Years
ALL
Yes
Sponsors
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Universidade Norte do Paraná
OTHER
Universidade Estadual de Londrina
OTHER
Responsible Party
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Principal Investigators
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Carlos A Camillo, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Estadual de Londrina
Locations
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Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2.143.496
Identifier Type: -
Identifier Source: org_study_id
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