Public trial
RBR-6xqcr4 Assessment cardiorespiratory in recovered Covid-19 patients
Date of registration: 07/10/2020 (mm/dd/yyyy)Last approval date : 07/10/2020 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
en
Cardiorespiratory fitness and neuromuscular performance in recovered Covid-19 patients
pt-br
Aptidão cardiorrespiratória e desempenho neuromuscular em pacientes recuperados da Covid-19
Trial identification
- UTN code: U1111-1254-8568
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Public title:
en
Assessment cardiorespiratory in recovered Covid-19 patients
pt-br
Avaliação cardiorrespiratória em pacientes recuperados da Covid-19
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Scientific acronym:
en
CPET
pt-br
TCPE
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Public acronym:
en
COVID-19
pt-br
COVID-19
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Secondaries identifiers:
-
34234720.0.0000.5184
Issuing authority: Plataforma Brasil
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4.132.248
Issuing authority: Comitê de Ética do Instituto de Educação Superior da Paraíba - IESP
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34234720.0.0000.5184
Sponsors
- Primary sponsor: LETFAS-UFPB
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Secondary sponsor:
- Institution: LETFAS-UFPB
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Supporting source:
- Institution: LETFAS-UFPB
- Institution: LETFAS-UFPB
Health conditions
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Health conditions:
en
Coronavirus Infections
pt-br
Infecções por Coronavirus
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General descriptors for health conditions:
en
C23 Pathological conditions, signs and symptoms
pt-br
C23 Condições patológicas, sinais e sintomas
es
C23 Condiciones patológicas, signos y síntomas
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Specific descriptors:
Interventions
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Interventions:
en
Experimental group: 80 patients recovered from COVID 19 will undergo a cardiopulmonary exercise test on a cycle ergometer (ramp protocol) to assess cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography to assess neuromuscular efficiency . Control group: 70 people not affected by the disease caused by the coronavirus, will be submitted to the cardiopulmonary exercise test on a cycle ergometer (ramp protocol) to assess the cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography, for assess neuromuscular efficiency.
pt-br
Experimental group: 80 patients recovered from COVID 19 will undergo a cardiopulmonary exercise test on an exercise bike (ramp protocol) to assess cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography to assess neuromuscular efficiency . Control group: 70 people not affected by the disease caused by the coronavirus, will be submitted to the cardiopulmonary exercise test on an exercise bike (ramp protocol) to assess the cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography, for assess neuromuscular efficiency.
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Descriptors:
en
G11.427.680.270 Exercise Tolerance
pt-br
G11.427.680.270 Tolerância ao Exercício
es
G11.427.680.270 Tolerancia al Ejercicio
en
E01.370.405.255 Electromyography
pt-br
E01.370.405.255 Eletromiografia
es
E01.370.405.255 Electromiografía
en
G03.680 Oxygen Consumption
pt-br
G03.680 Consumo de Oxigênio
es
G03.680 Consumo de Oxígeno
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 07/01/2020 (mm/dd/yyyy)
- Date last enrollment: 10/01/2020 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 150 - 18 Y 59 Y -
Inclusion criteria:
en
Patients recovered from Covid-19 with mild to severe severity (recovery within 30 days) and people not contaminated by the coronavirus; both sexes; non smokers; 18 years old or older
pt-br
Pacientes recuperados da Covid-19 com gravidade leve a severa (recuperação até 30 dias) e pessoas não contaminadas pelo coronavírus; ambos os sexos; não fumantes; idade igual ou superior a 18 anos
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Exclusion criteria:
en
Smoking volunteers; pregnancy; morbid obesity; diagnoses of cardiac, pulmonary, hematological, neurological or neuromuscular diseases
pt-br
Voluntários fumantes; gravidez; obesidade mórbida; diagnósticos de doenças cardíacas, pulmonares, hematológicas, neurológicas ou neuromusculares
Study type
-
Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Other N/A 0 N/A N/A N/A
Outcomes
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Primary outcomes:
en
Presentation of the expected outcome: To assess the maximum oxygen uptake [VO2max] in patients recovered from COVID 19 and healthy individuals. Patients recovered from COVID 19, with severe severity, are expected to have lower VO2max compared to patients recovered from COVID 19 who had mild symptoms or with healthy individuals (not infected by the coronavirus). VO2max will be obtained in the cardiopulmonary exercise test [CPET], using the ramp protocol on a cycle ergometer. VO2max will be presented in absolute values (L min) and in% predicted values.
pt-br
Apresentação do desfecho esperado: Avaliar o consumo máximo de oxigênio [VO2max] em pacientes recuperados da COVID 19 e indivíduos saudáveis. Espera-se que pacientes recuperados da COVID 19, com gravidade severa, tenha menor VO2max comparado com pacientes recuperados da COVID 19, que tiveram sintomas leves ou com os indivíduos saudáveis (não foram contaminados pelo coronavírus). O VO2max será obtido no teste cardiopulmonar de exercício [TCPE], utilizando o protocolo de rampa em bicicleta ergométrica. O VO2max será apresentado em valores absolutos (L/min) e em valores % do predito.
en
Presentation of the expected outcome: To assess neuromuscular efficiency [relationship between workload variation with the percentage of muscle activation] in patients recovered from COVID 19 and healthy individuals. Patients recovered from COVID 19, with severe symptoms, are expected to have lower neuromuscular efficiency compared to patients recovered from COVID 19, who had mild symptoms or with healthy individuals (not infected by coronavirus). The variation of workloads will be evaluated during the cardiopulmonary exercise test [25, 50, 75 and 100 watts] The percentage of muscle activation will be obtained by surface electromyography of the vastus lateralis muscle and will be presented in %RMS.
pt-br
Apresentação do desfecho esperado: Avaliar a eficiência neuromuscular [relação entre a variação da carga de trabalho com o percentual da ativação muscular] em pacientes recuperados da COVID 19 e indivíduos saudáveis. Espera-se que pacientes recuperados da COVID 19, com gravidade severa, tenha menor eficiência neuromuscular comparado com pacientes recuperados da COVID 19, que tiveram sintomas leves e com os indivíduos saudáveis (não foram contaminados pelo coronavírus). A variação das cargas de trabalho serão avaliadas durante o teste cardiopulmonar de exercício [25, 50, 75 e 100 watts] O percentual da ativação muscular serão obtidas pela eletromiografia de superfície do músculo vasto lateral e será apresentado em %RMS.
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Secondary outcomes:
en
Presentation of the expected outcome: Assess the oxygen pulse in patients recovered from COVID 19 and healthy individuals. It is expected that patients recovered from COVID 19, with severe severity, will have a lower oxygen pulse compared with patients recovered from COVID 19, who had mild symptoms or with healthy individuals (they were not contaminated by the coronavirus). The oxygen Pulse will be obtained in the cardiopulmonary exercise test, using the ramp protocol on an exercise bike. This variable will be presented in mL/ heart rate.
pt-br
Apresentação do desfecho esperado: Avaliar o pulso de oxigênio em pacientes recuperados da COVID 19 e indivíduos saudáveis. Espera-se que pacientes recuperados da COVID 19, com gravidade severa, tenha menor pulso de oxigênio comparado com pacientes recuperados da COVID 19, que tiveram sintomas leves ou com os indivíduos saudáveis (não foram contaminados pelo coronavírus). O pulso de oxygen será obtido no teste cardiopulmonar de exercício, utilizando o protocolo de rampa em bicicleta ergométrica. Essa variável será apresentada em mL /batimentos cardíacos.
en
Presentation of the expected outcome: To assess ventilation in patients recovered from COVID 19 and healthy individuals. It is expected that patients recovered from COVID 19, with severe symptoms will have less ventilation compared to patients recovered from COVID 19, who had mild symptoms or with healthy individuals (they were not contaminated by the coronavirus). Ventilation will be achieved by spirometry during the cardiopulmonary exercise test, using the ramp protocol on a cycle ergometer. This variable will be measured in L min.
pt-br
Apresentação do desfecho esperado: Avaliar a ventilação em pacientes recuperados da COVID 19 e indivíduos saudáveis. Espera-se que pacientes recuperados da COVID 19, com gravidade severa, tenha uma menor ventilação comparado com pacientes recuperados da COVID 19, que tiveram sintomas leves ou com os indivíduos saudáveis (não foram contaminados pelo coronavírus). A ventilação será obtida pelo espirometria durante o teste cardiopulmonar de exercício, utilizando o protocolo de rampa em bicicleta ergométrica. Essa variável será medida em L/min.
en
Presentation of the expected outcome: To evaluate the ventilatory equivalent [variation between ventilation with carbon dioxide - VE / CO2 slope] in patients recovered from COVID 19 and healthy individuals. It is expected that patients recovered from COVID 19, with severe symptoms, will have a lower ventilatory equivalent when compared to patients recovered from COVID 19, who had mild symptoms or with healthy individuals (they were not contaminated by the coronavirus). The ventilatory equivalent will be obtained by spirometry during the cardiopulmonary exercise test, using the ramp protocol on a cycle ergometer. This variable will be measured in L / min.
pt-br
Apresentação do desfecho esperado: Avaliar o equivalente ventilatório [variação entre a ventilação com o dióxido de carbono - VE/CO2 slope] em pacientes recuperados da COVID 19 e indivíduos saudáveis. Espera-se que pacientes recuperados da COVID 19, com gravidade severa, tenha um menor equivalente ventilatório quando comparado com pacientes recuperados da COVID 19, que tiveram sintomas leves ou com os indivíduos saudáveis (não foram contaminados pelo coronavírus). O equivalente ventilatório será obtido pela espirometria durante o teste cardiopulmonar de exercício, utilizando o protocolo de rampa em bicicleta ergométrica. Essa variável será medida em L/min.
Contacts
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Public contact
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Maria do Socorro Brasileiro-Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brasil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 98202-7067
- Email: sbrasileiro@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Murillo Frazao
-
- Address: Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99362-2322
- Email: murillo.frazao@gmail.com
- Affiliation: LETFAS-UFPB
-
Scientific contact
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Maria do Socorro Brasileiro-Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brasil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 98202-7067
- Email: sbrasileiro@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Murillo Frazao
-
- Address: Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99362-2322
- Email: murillo.frazao@gmail.com
- Affiliation: LETFAS-UFPB
-
Site contact
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Amilton da Cruz Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 99352-3994
- Email: adagatom@yahoo.com.br
- Affiliation: LETFAS-UFPB
- Full name: Maria do Socorro Brasileiro-Santos
-
- Address: Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brasil.
- City: Joao Pessoa / Brazil
- Zip code: 58051-900
- Phone: +55 83 98202-7067
- Email: sbrasileiro@yahoo.com.br
- Affiliation: LETFAS-UFPB
Additional links:
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