3R Rehabilitation Management of COVID-19 Survivors
18 de mayo de 2021 actualizado por: The Hong Kong Polytechnic University
3R Rehabilitation Management of COVID-19 Survivors Using Centre-based and Online-based Approaches
It is to explore the temporal relationships between physical fitness, cognitive, psychosocial functions, and health-related quality of life (HRQoL) in COVID-19 survivors over the first 15 months; and to determine the effects of centre-based (CBR), online-based cardiopulmonary rehabilitation (OBR), and combined centre- and online-based rehabilitation (COBR) on survivors with initially suboptimal pulmonary functions.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
400
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: Siu Ngor Fu, PhD
- Número de teléfono: 852-27666726
- Correo electrónico: amy.fu@polyu.edu.hk
Ubicaciones de estudio
-
-
-
Hong Kong, Hong Kong
- Reclutamiento
- Pamela Youde Eastern Hospital
-
Contacto:
- Loletta So
- Número de teléfono: 852-25956411
- Correo electrónico: soky@ha.org.hk
-
Hong Kong, Hong Kong
- Reclutamiento
- Princess Margaret Hospital
-
Contacto:
- Yiu Cheong Yeung
- Correo electrónico: yeungyc@ha.org.hk
-
Hong Kong, Hong Kong
- Reclutamiento
- Queen Elizabeth Hospital
-
Contacto:
- Wu Tak Chiu
- Número de teléfono: 852-35062049
- Correo electrónico: wutc@ha.org.hk
-
Hong Kong, Hong Kong
- Reclutamiento
- Tuen Mun Hospital
-
Contacto:
- Yuk Yung Ng
- Correo electrónico: ngyy3@ha.org.hk
-
-
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- COVID survivor at hospital discharge or 6-month post-disease onset
- Medically stable with an Abbreviated Mental Test (AMT) scores of > 6 out of 10
Exclusion Criteria:
- Having contraindications to exercise
- Physical Activity Readiness Questionnaire (PAR-Q) reveals unsafety
- Cannot understand Cantonese
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Centre-based
Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Depending on the preference of participants, they can either choose to join three 60-minute centre-based sessions plus two sessions of 30-minute home exercise per week, or two 60-minute centre-based sessions plus four sessions of 30-minute home exercise per week.
Each session will include warm-up and cool-down exercises, aerobic exercises, and progressive strengthening exercises prescribed based on individual ability (Table 1).
Aerobic exercises will be performed at 60-75% (up to 85% for fit individuals) of the predicted maximum heart rate.
The respective rate of perceived exertion during exercise will be maintained between 4 and 6 out of 10 on the Borg CR scale [10], indicating moderate to strenuous exercise levels.
Additionally, physiotherapists will provide education related to COVID-19, energy conservation, and stress management during the program.
|
|
Experimental: Online-based
Online-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Participants in the OBR group will attend one face-to-face session to learn how to use a mobile application (app) followed by 6 weeks of home exercises.
The online treatments will be delivered via the Caspar Health e-system, a German-designed Internet-based system, is available for desktop PCs and as a mobile app for both iOS and Android smartphones.
This system will enable patients to follow their therapists' treatment plans in an asynchronous manner.
The OBR programme will last for 6 weeks.
Participants will be instructed to perform 40 minutes of structured exercises 6 times per week.
In the first week, six 40-minute online exercise sessions will be delivered through push notifications on the mobile app.
|
|
Experimental: Combined
Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks
|
Depending on the preference of participants, they can either choose to join three 60-minute centre-based sessions plus two sessions of 30-minute home exercise per week, or two 60-minute centre-based sessions plus four sessions of 30-minute home exercise per week.
Each session will include warm-up and cool-down exercises, aerobic exercises, and progressive strengthening exercises prescribed based on individual ability (Table 1).
Aerobic exercises will be performed at 60-75% (up to 85% for fit individuals) of the predicted maximum heart rate.
The respective rate of perceived exertion during exercise will be maintained between 4 and 6 out of 10 on the Borg CR scale [10], indicating moderate to strenuous exercise levels.
Additionally, physiotherapists will provide education related to COVID-19, energy conservation, and stress management during the program.
Participants in the OBR group will attend one face-to-face session to learn how to use a mobile application (app) followed by 6 weeks of home exercises.
The online treatments will be delivered via the Caspar Health e-system, a German-designed Internet-based system, is available for desktop PCs and as a mobile app for both iOS and Android smartphones.
This system will enable patients to follow their therapists' treatment plans in an asynchronous manner.
The OBR programme will last for 6 weeks.
Participants will be instructed to perform 40 minutes of structured exercises 6 times per week.
In the first week, six 40-minute online exercise sessions will be delivered through push notifications on the mobile app.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fatigue measured by Fatigue Assessment Scale
Periodo de tiempo: 6 weeks after the start of intervention
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
6 weeks after the start of intervention
|
|
Fatigue measured by Fatigue Assessment Scale
Periodo de tiempo: Baseline
|
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise
test.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle strength by 30-second double-leg sit-to-stand test (times)
Periodo de tiempo: Baseline
|
Muscle strength will be assessed with the 30-second double-leg sit-to-stand test.
If the participant can perform the 30-second single leg sit-to-stand test with pain or difficulty, they will be invited to complete 30-second single-leg sit-to-stand test.
The number of completed repetitions will be counted.
|
Baseline
|
|
Muscle strength by 30-second double-leg sit-to-stand test (times)
Periodo de tiempo: 6 weeks after the start of intervention
|
Muscle strength will be assessed with the 30-second double-leg sit-to-stand test.
If the participant can perform the 30-second single leg sit-to-stand test with pain or difficulty, they will be invited to complete 30-second single-leg sit-to-stand test.
The number of completed repetitions will be counted.
|
6 weeks after the start of intervention
|
|
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
Periodo de tiempo: Baseline
|
A six-item digital self-administered self-efficacy questionnaire will be used to evaluate patients' confidence in performing exercise, managing their own symptoms and emotions and completing their daily tasks.
|
Baseline
|
|
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
Periodo de tiempo: 6 weeks after the start of intervention
|
A six-item digital self-administered self-efficacy questionnaire will be used to evaluate patients' confidence in performing exercise, managing their own symptoms and emotions and completing their daily tasks.
|
6 weeks after the start of intervention
|
|
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
Periodo de tiempo: Baseline
|
The St. George's Respiratory Questionnaire-HK version is a self-reported questionnaire.
This 50-item disease specific questionnaire assesses 3 domains (symptoms, activity, and impacts).
|
Baseline
|
|
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
Periodo de tiempo: 6 weeks after the start of intervention
|
The St. George's Respiratory Questionnaire-HK version is a self-reported questionnaire.
This 50-item disease specific questionnaire assesses 3 domains (symptoms, activity, and impacts).
|
6 weeks after the start of intervention
|
|
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
Periodo de tiempo: Baseline
|
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
|
Baseline
|
|
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
Periodo de tiempo: 6 weeks after the start of intervention
|
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
|
6 weeks after the start of intervention
|
|
Cardiac output (L/min)
Periodo de tiempo: Baseline
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
Baseline
|
|
Cardiac output (L/min)
Periodo de tiempo: 6 weeks after the start of intervention
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
6 weeks after the start of intervention
|
|
Cardiac stroke volume (ml/m2)
Periodo de tiempo: Baseline
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
Baseline
|
|
Cardiac stroke volume (ml/m2)
Periodo de tiempo: 6 weeks after the start of intervention
|
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall by a non-invasive measurement of cardiac output using the CardioScreen 1000 System.
Non-invasive electrodes will be placed on the clavicle and lateral side of chest wall bilaterally
|
6 weeks after the start of intervention
|
|
Forced expiratory volume in one second (l)
Periodo de tiempo: Baseline
|
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
|
Baseline
|
|
Forced expiratory volume in one second (l)
Periodo de tiempo: 6 weeks after the start of intervention
|
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
|
6 weeks after the start of intervention
|
|
Forced vital capacity (l)
Periodo de tiempo: Baseline
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
Baseline
|
|
Forced vital capacity (l)
Periodo de tiempo: 6 weeks after the start of intervention
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
|
6 weeks after the start of intervention
|
|
FEV1/FVC
Periodo de tiempo: Baseline
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
Baseline
|
|
FEV1/FVC
Periodo de tiempo: 6 weeks after the start of intervention
|
Ratio of forced expiratory volume in one second and forced vital capacity
|
6 weeks after the start of intervention
|
|
Peak expiratory flow rate (l/s)
Periodo de tiempo: Baseline
|
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
|
Baseline
|
|
Peak expiratory flow rate (l/s)
Periodo de tiempo: 6 weeks after the start of intervention
|
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
|
6 weeks after the start of intervention
|
|
Exercise capacity (m)
Periodo de tiempo: Baseline
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
Baseline
|
|
Exercise capacity (m)
Periodo de tiempo: 6 weeks after the start of intervention
|
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
|
6 weeks after the start of intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
- Investigador principal: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital
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)
1 de octubre de 2020
Finalización primaria (Anticipado)
31 de marzo de 2022
Finalización del estudio (Anticipado)
31 de marzo de 2022
Fechas de registro del estudio
Enviado por primera vez
1 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2021
Publicado por primera vez (Actual)
19 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSEARS20200912001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre COVID-19
-
VA Office of Research and DevelopmentActivo, no reclutandoPacientes con EPOC y pacientes que se recuperan de COVID19Estados Unidos
-
HealthQuiltTerminadoFunción inmune | Paciente Positivo Covid19 | Covid19 contacto cercanoEstados Unidos
-
Bahçeşehir UniversityTerminadoLargo Covid19 | Disfunción autonómicaPavo
-
Ohio State UniversityReclutamientoSíndrome post-agudo de COVID19 | COVID largo | Condición posterior a COVID19Estados Unidos
-
Brugmann University HospitalReclutamiento
-
Assiut UniversityAún no reclutando
-
Istituti Clinici Scientifici Maugeri SpAIstituto Auxologico Italiano; Azienda Ospedaliera Bolognini di Seriate Bergamo; Azienda Socio Sanitaria Territoriale di Bergamo y otros colaboradoresTerminado
-
Bassett HealthcareBioreference, IncTerminadoInmunología Covid19Estados Unidos
-
Associazione Chirurghi Ospedalieri ItalianiTerminado
-
Gamaleya Research Institute of Epidemiology and...Government of the city of Moscow; CRO: Crocus Medical BVDesconocidoPrevención Covid19Federación Rusa