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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
RBR-9s6zpjs |
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Date of registration:
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24/04/2024 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical aspects of long-term follow-up of patients wtih Covid-19 after hospitalization in HC-Unicamp
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Scientific title:
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Epidemiological and clinical-evolutionary aspects of a cohort of patients hospitalized with Covid-19 at HC-Unicamp |
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Date of first enrolment:
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10/06/2020 |
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Target sample size:
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Recruitment status: |
Recruitment completed |
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URL:
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https://ensaiosclinicos.gov.br/rg/RBR-9s6zpjs |
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Study type:
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Intervention |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Mônica Corso Pereira
-faculdade de ciências médicas |
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Address:
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R. Tessália Vieira de Camargo, 126 - Cidade Universitária
13083-887
Campinas
Brazil |
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Telephone:
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+55 (19) 3521.7871 |
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Email:
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moncorso@unicamp.br |
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Affiliation:
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Universidade Estadual de Campinas |
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Name:
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Mônica Corso Pereira
-faculdade de ciências médicas |
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Address:
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R. Tessália Vieira de Camargo, 126 - Cidade Universitária
13083-887
Campinas
Brazil |
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Telephone:
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+55 (19) 3521.7871 |
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Email:
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moncorso@unicamp.br |
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Affiliation:
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Universidade Estadual de Campinas |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients of both sexes; greater than or equal to 18 years old; diagnosis of severe COVID-19 who have been hospitalised; post-discharge outpatient assessment, have dyspnoea at rest; or a distance covered in the six-minute walk test of less than or equal to 400 metres and or 80% of that predicted using a predictive reference equation; or a drop in peripheral oxygen saturation of greater than or equal to 4 points
Exclusion criteria: Osteoarticular or cognitive limitations; or patients with a tracheostomy; or patients with previous respiratory or cardiovascular diseases that prevent the participant from performing the proposed tests
Age minimum:
18Y
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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C01.748
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Post-Acute COVID-19 Syndrome; Respiratory Insufficiency
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Intervention(s)
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This is a longitudinal, prospective, randomised, open clinical study. Total patients included: 60 patients coming out of hospitalisation for severe COVID-19. Randomisation to group 1: 30 patients who will take part in a pulmonary telerehabilitation programme with exclusively remote supervision, or group 2: 30 patients who will take part in a pulmonary telerehabilitation programme with both remote and face-to-face supervision. Duration of the programme: 12 weeks, with sessions held at least three times a week. Evaluation procedures for the two groups, pre and post telerehabilitation programme: six-minute walk test, SF-36 quality of life questionnaire, and assessment of respiratory muscle strength and handgrip strength.
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Primary Outcome(s)
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Expected Outcome 1: The study aims to observe an improvement in functional capacity, as measured by an increase of at least 50 metres in the distance covered during the six-minute walk test, between pre- and post-intervention
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Outcome found 1:The six-minute walk test showed an increase of 164.5 metres in group 1 and 154.2 metres in group 2 between the pre- and post-intervention periods
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Secondary Outcome(s)
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Expected outcome 3: The intervention is expected to improve functional capacity, as measured by the increase in distance walked in the six-minute walk test, between baseline and after six months of follow-up
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Expected outcome 6: We expected to find a significant increase in handgrip strength assessed using a hand-held dynamometer between pre- and post-intervention
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Expected outcome 2: It is expected that there will be a significant improvement in the quality of life, as measured by the SF-36 survey, between pre- and post-intervention
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Expected outcome 4: We expect to find a significant increase in respiratory muscle strength assessed by means of maximum respiratory pressures between the pre- and post-intervention periods
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Outcome found 4: There was a significant improvement in respiratory muscle strength between pre- and post-intervention
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Outcome found 6: There was an improvement in handgrip strength between pre- and post-intervention
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Outcome found 5: There was an improvement in respiratory muscle endurance between pre- and post-intervention
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Expected Outcome 5: A significant increase in respiratory muscle endurance, as assessed using the Powerbreathe KH2 equipment, is expected between the pre- and post-intervention periods
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Outcome found 2: There was a significant improvement in the quality of life, as evidenced by the scores of the physical and mental summary components of the SF-36 survey, between pre- and post-intervention
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Outcome found 3: There was an improvement in functional capacity between baseline and after six months of follow-up
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Source(s) of Monetary Support
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Fundação de Amparo à Pesquisa do Estado de São Paulo
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Ethics review
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Status: Approved
Approval date: 11/08/2020
Contact:
cep@unicamp.br
Comitê de Ética em Pesquisa Faculdade de Ciências Médicas
+55(19)35218936; +55(19)35217187
cep@unicamp.br
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