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3R Rehabilitation Management of COVID-19 Survivors

18 mai 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recrutement
        • Pamela Youde Eastern Hospital
        • Contact:
          • Loletta So
          • Numéro de téléphone: 852-25956411
          • E-mail: soky@ha.org.hk
      • Hong Kong, Hong Kong
        • Recrutement
        • Princess Margaret Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recrutement
        • Queen Elizabeth Hospital
        • Contact:
          • Wu Tak Chiu
          • Numéro de téléphone: 852-35062049
          • E-mail: wutc@ha.org.hk
      • Hong Kong, Hong Kong
        • Recrutement
        • Tuen Mun Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Centre-based
Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks
Autre: 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.
Expérimental: Online-based
Online-based exercise cardiopulmonary rehabilitation program for 6 weeks
Autre: 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.
Expérimental: Combined
Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fatigue measured by Fatigue Assessment Scale
Délai: 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
Délai: Baseline
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Baseline

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Hong Kong Polytechnic University

Collaborateurs

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

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2020

Achèvement primaire (Anticipé)

31 mars 2022

Achèvement de l'étude (Anticipé)

31 mars 2022

Dates d'inscription aux études

Première soumission

1 mars 2021

Première soumission répondant aux critères de contrôle qualité

18 mai 2021

Première publication (Réel)

19 mai 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2021

Dernière vérification

1 février 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HSEARS20200912001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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