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| ID | Type | Description | Link |
|---|---|---|---|
| 4.666.483 | Other Identifier | CEP-UFPE |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| Universidade Federal de Pernambuco | OTHER |
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The COVID-19 pandemic, a disease caused by the SARS-CoV-2 virus, has generated an inexplicable scenario for global health, causing different complications and degrees of functional impairment in millions of people who manage to recover from the disease. The respiratory system is the main system to be directly impacted during COVID-19 infection, and its treatment can generate changes in the respiratory function of individuals surviving the exacerbation of the disease, which may promote subjective and quantitative changes in the respiratory pattern, requiring an evaluation with high-cost instruments, an evaluation necessary to outline a better planning therapeutic for this population. The goal of this study is evaluate the breathing pattern variables using a device called RESPIRATORY DIAGNOSTIC ASSISTANT (RDA) and verify the relationship between the breathing pattern variables with the variables of pulmonary function, respiratory muscle strength and respiration in patients after involvement by COVID-19. This is a observational and validation study, prospective with follow-up of respiratory function for 6 months, a subproject linked to the project already approved by the research ethics committee under opinion: 4.362.977/4.596.02. Data collection will be carried out in a single day and divided into a few steps that will take place at the cardiopulmonary physiotherapy laboratory located at the physiotherapy department of the Federal University of Pernambuco. The first step is to conduct an interview with the participants to collect clinical data and perform a physical examination. Subsequently, a multidimensional evaluation of respiratory function will be performed. Statistical analysis will be performed using the Statistical Package For Social Science (SPSS) software version 20.0 for Windows. The Kolmogorov-Smirnov test will be used to verify the type of distribution, regarding the normality of the variables, and the significance level adopted will be 95% (α <0.05) for all analyses. Finally, the data obtained will be presented in tables and/or graphs.
The sample will consist of volunteers with laboratory confirmed COVID-19 results who have SARS COV 2 variants tracked by the epidemiological surveillance of Caruaru-Pernambuco and will be recruited by coexistence in a non-probabilistic way. The sample study will be obtained through data provided by the municipal health department of the city of Caruaru-Pernambuco with a predicted sample of 131 people. In order to minimize sample losses, 10% will be added to the total sample, which corresponds to 144 participants. The software that can be used is known as GPower (version 3.13 for Windows) considering a statistical power (β) of 80% and a significance level (α) of 5%.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study will not have intervention | Other | Study will not have intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing pattern diagnosis | The algorithm of the "Respiratory Diagnostic Assistant" device relates the variables respiratory rate, tidal volume, minute volume, inspiratory flow, expiratory flow, relationship between inspiratory and expiratory times, providing classification of breathing pattern during rest breathing. The "Respiratory Diagnosis Assistant" algorithm provides through graphs allowing the classification of the diagnosis in normal or altered.
| "Until the Completion of the Study, On Average 1 Year" |
| Breathing pattern variables | The algorithm of the "Respiratory Diagnostic Assistant" device relates the variables respiratory rate, tidal volume, minute volume, inspiratory flow, expiratory flow, relationship between inspiratory and expiratory times. The variables of the breathing pattern will also be quantitatively evaluated::
| "Until the Completion of the Study, On Average 1 Year" |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | Lung function tests are usually performed with computerized systems that analyze the data and provide immediate results. The spirometer associates variables capable of tracing a functional diagnosis of the respiratory system:
Functional Diagnosis:
|
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test | Evaluation of functional capacity, through submaximal effort, through data obtained during a six-minute walk. The pre-test and post-test variables were measured:
|
Inclusion Criteria:
Exclusion Criteria:
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The population will consist of patients of both sexes, aged over 18 years, who had a confirmed diagnosis of the new coronavirus (COVID-19) through laboratory tests such as the molecular biology test (RT-PCR) or serological. This sample will be matched by 90 individuals according to sex and age group without a confirmed diagnosis of COVID-19 and with a self-report of absence of symptoms related to COVID-19
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiley L Campos, PhD | Contact | +55 (81) 2126-8492 | shirley.campos@ufpe.br | |
| JAKSON H SILVA, Esp | Contact | +55 (81) 2126-8492 | jakson.silva@ufpe.br |
| Name | Affiliation | Role |
|---|---|---|
| Shirley L Campos, Phd | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pernambuco Department of Physiotherapy | Recruiting | Recife | Pernambuco | 50740-560 | Brazil |
Não: Não há um plano para disponibilizar o IPD
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| "Until the Completion of the Study, On Average 1 Year" |
| Assessment of lung volumes and capacities by ventilometry | Non-invasive analogue assessment of lung volumes and capacities, easy to understand, with quantitative variables Respiratory rate (RR) (measured in incursion per minute) Minute volume (MV), (measured in liters) Tidal volume (TV), (measured in liters) Inspiratory capacity (IC) (measured in liters) Vital capacity (CL) (measured in liters) | "Until the Completion of the Study, On Average 1 Year" |
| Maximum inspiratory pressure (Manuvacuometry) | Manuvacuometry: Non-invasive measurement of inspiratory muscle pressure.
| "Until the Completion of the Study, On Average 1 Year" |
| Maximum expiratory pressure (Manuvacuometry) | Manuvacuometry: Non-invasive measurement of inspiratory muscle pressure.
| "Until the Completion of the Study, On Average 1 Year" |
| "Until the Completion of the Study, On Average 1 Year" |
| Palmar Grip Strength | Assessment of handgrip strength through the dynamometry, measuring grip strength in a total of three repetitions, taking into account the greatest strength obtained in kilograms (kg/f) | "Until the Completion of the Study, On Average 1 Year" |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |