Analysis of Breathing Pattern Post COVID-19

NCT ID: NCT05659615

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-02-10

Brief Summary

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.

Detailed Description

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%.

Conditions

Covid19

Keywords

COVID-19; Diagnosis; Physiotherapy; Breathing Pattern

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Study will not have intervention

Study will not have intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older than 18 years;
• Diagnosed with COVID-19;
• After the period of home isolation or hospital discharge;
• More than 40 days without the presence of symptoms associated with COVID-19;

Exclusion Criteria

• Participants who are unable to perform the assessment tests or who present contraindications to the assessment of respiratory function;
• Those patients who prove reinfection by the new Coronavirus;
• Pregnant patients;
• Refusal to sign the Free and Informed Consent Form (FICF)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Pernambuco

OTHER

Sponsor Role: collaborator

Shirley Lima Campos

OTHER

Sponsor Role: lead

Responsible Party

Shirley Lima Campos

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shirley L Campos, Phd

Role: STUDY_DIRECTOR

Universidade Federal de Pernambuco

Locations

Federal University of Pernambuco Department of Physiotherapy

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Shiley L Campos, PhD

Role: CONTACT

Phone: +55 (81) 2126-8492

Email: shirley.campos@ufpe.br

JAKSON H SILVA, Esp

Role: CONTACT

Phone: +55 (81) 2126-8492

Email: jakson.silva@ufpe.br

Facility Contacts

Shirley L Campos, 1

Role: primary

Jakson H Silva, 2

Role: backup

Other Identifiers

4.666.483

Identifier Type: OTHER

Identifier Source: secondary_id

44382120.3.0000.5208

Identifier Type: -

Identifier Source: org_study_id