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| Name | Class |
|---|---|
| Universidade Norte do Paraná | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ILD | Patients with a medical diagnosis of interstitial lung disease. Patients will be submitted to the assessment of:
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| Control Group | Age-matched peers without lung diseases. Participants will be submitted to the assessment of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily physical activity levels | Diagnostic Test | Objectively measured physical activity using activity monitors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Patients with interstitial lung disease:
Age-matched control group:
Exclusion Criteria (both groups):
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A non-probabilistic sample (invitation to volunteer) including participants from the urban region of Londrina, Brazil and surroundings.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos A Camillo, PT, PhD | Contact | +554333712490 | carlos.a.camillo@outlook.com | |
| Fabio Pitta, PT, PhD | Contact | +554333712477 | fabio.pitta@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Carlos A Camillo, PT, PhD | Universidade Estadual de Londrina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual de Londrina | Recruiting | Londrina | Paraná | 86038-350 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38272247 | Derived | 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. |
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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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Clinical and biological data collected in the study may be used in other investigations upon participants written consent
| 6-minute walk test | Diagnostic Test | Assessment of functional exercise capacity. |
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| Cardiopulmonary exercise testing | Diagnostic Test | Assessment of maximal exercise capacity. |
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| Muscle Function | Diagnostic Test | Assessment of muscle force, muscle endurance and muscle fatigability |
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| Lung Function | Diagnostic Test | Assessment of whole-body plethysmography and spirometry. |
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| Body composition | Diagnostic Test | Assessment of bioelectrical impedance. |
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| HRQoL - SGRQ-I | Diagnostic Test | Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)" |
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| Symptoms - UCSD/SOBQ | Diagnostic Test | Assessment of symptoms by the "UCSD Short of breath questionnaire" |
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| HRQoL - SF36 | Diagnostic Test | Assessment of Health-related quality of life by the "SF-36 questionnaire" |
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| Anxiety and depression | Diagnostic Test | Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale" |
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| Symptoms - mMRC | Diagnostic Test | Assessment of symptoms by the "modified Medical Research Council (mMRC) scale" |
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| Sleep quality | Diagnostic Test | Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)" |
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| Sleepiness | Diagnostic Test | Assessment of sleepiness by the "Epworth Sleepiness Scale" |
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| Inflammatory markers and oxidative stress | Diagnostic 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 tests | Diagnostic 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). |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000070857 | Walk Test |
| D005080 | Exercise Test |
| D012119 | Respiration |
| D001823 | Body Composition |
| D018384 | Oxidative Stress |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D001824 | Body Constitution |
| D010829 | Physiological Phenomena |
| D013312 | Stress, Physiological |
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