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3R Rehabilitation Management of COVID-19 Survivors

18 de maio de 2021 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

400

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recrutamento
        • Pamela Youde Eastern Hospital
        • Contato:
      • Hong Kong, Hong Kong
        • Recrutamento
        • Princess Margaret Hospital
        • Contato:
      • Hong Kong, Hong Kong
        • Recrutamento
        • Queen Elizabeth Hospital
        • Contato:
          • Wu Tak Chiu
          • Número de telefone: 852-35062049
          • E-mail: wutc@ha.org.hk
      • Hong Kong, Hong Kong
        • Recrutamento
        • Tuen Mun Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Centre-based
Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks
Outro: Cardiopulmonary exercise (centre-based)
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
Outro: Cardiopulmonary exercise (online-based)
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
Outro: Cardiopulmonary exercise (centre-based)
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.
Outro: Cardiopulmonary exercise (online-based)
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fatigue measured by Fatigue Assessment Scale
Prazo: 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
Prazo: Baseline
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Muscle strength by 30-second double-leg sit-to-stand test (times)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
Baseline
Forced vital capacity (l)
Prazo: 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
Prazo: Baseline
Ratio of forced expiratory volume in one second and forced vital capacity
Baseline
FEV1/FVC
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
Baseline
Exercise capacity (m)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Hong Kong Polytechnic University

Colaboradores

Queen Elizabeth Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Tuen Mun Hospital Hong Kong

Investigadores

  • Investigador principal: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
  • Investigador principal: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de outubro de 2020

Conclusão Primária (Antecipado)

31 de março de 2022

Conclusão do estudo (Antecipado)

31 de março de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

1 de março de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2021

Primeira postagem (Real)

19 de maio de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de maio de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HSEARS20200912001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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