Home-based Exercise in COVID-19 Survivors
10 de junio de 2022 actualizado por: Bruno Gualano, University of Sao Paulo
Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function.
Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bruno Gualano, PhD
- Número de teléfono: 8021 55112661
- Correo electrónico: gualano@usp.br
Ubicaciones de estudio
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Sao Paulo, Brasil, 05508-030
- Reclutamiento
- University of Sao Paulo
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients diagnosed with COVID-19
- Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- Admitted in intensive care unit
Exclusion Criteria:
- Cardiovascular disease
- Resting dyspnea
- Acute pulmonary embolism or pulmonary infarction
- Deep venous thromboembolism
- Uncontrolled visual or vestibular disorders
- Pregnancy
- Uncontrolled resting tachycardia
- Uncontrolled hypertension
- Uncontrolled Type II diabetes
- Acute infections
- Neurological disorders
- Patients with chronic kidney disease who are in need of hemodialysis
- Recent malignant neoplasm (<5 years)
- Autoimmune diseases
- Complex ventricular arrhythmias, atrial fibrillation or complete heart block
- Transplant patients
- Any physical disabilities that could hamper physical testing and exercise program
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo de ejercicios
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A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week.
The training program will involve strength, aerobic, balance and flexibility exercises.
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Sin intervención: Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means better outcome.
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Baseline and 16 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on lipid profile at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
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Baseline and 16 weeks.
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Change from baseline on insulin sensitivity at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Fasting serum concentrations of glucose and insulin.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on C-reactive Protein at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on Creatine Kinase at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on waist circumference at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on hip circumference at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on body weight at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Periodo de tiempo: Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Periodo de tiempo: Baseline and one year.
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Higher score means better outcome.
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Baseline and one year.
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Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Periodo de tiempo: Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on fatigue assessed by Chalder scale at one year.
Periodo de tiempo: Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Periodo de tiempo: Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Periodo de tiempo: Baseline and one year.
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Baseline and one year.
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Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Periodo de tiempo: Baseline and one year.
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Baseline and one year.
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Change from baseline on muscular strength assessed by handgrip test at one year.
Periodo de tiempo: Baseline and one year.
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Baseline and one year.
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Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Periodo de tiempo: Baseline and one year.
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Baseline and one year.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de septiembre de 2020
Finalización primaria (Anticipado)
30 de septiembre de 2022
Finalización del estudio (Anticipado)
30 de septiembre de 2022
Fechas de registro del estudio
Enviado por primera vez
29 de octubre de 2020
Primero enviado que cumplió con los criterios de control de calidad
2 de noviembre de 2020
Publicado por primera vez (Actual)
4 de noviembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2022
Última verificación
1 de junio de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Síndrome respiratorio agudo severo
- COVID-19
Otros números de identificación del estudio
- 4.342.082
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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