3R Rehabilitation Management of COVID-19 Survivors

Study Overview
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Brief Summary
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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.

Official Title
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3R Rehabilitation Management of COVID-19 Survivors Using Centre-based and Online-based Approaches

Conditions
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Covid19

Intervention / Treatment
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* Other: Cardiopulmonary exercise (centre-based)
* Other: Cardiopulmonary exercise (online-based)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Centre-based<br>Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks | Other: Cardiopulmonary exercise (centre-based)<br>* 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.<br>|
| Experimental: Online-based<br>Online-based exercise cardiopulmonary rehabilitation program for 6 weeks | Other: Cardiopulmonary exercise (online-based)<br>* 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.<br>|
| Experimental: Combined<br>Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks | Other: Cardiopulmonary exercise (centre-based)<br>* 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.<br>Other: Cardiopulmonary exercise (online-based)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue measured by Fatigue Assessment Scale | 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 | The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength by 30-second double-leg sit-to-stand test (times) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration | Baseline | 
| Forced vital capacity (l) | 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 | Ratio of forced expiratory volume in one second and forced vital capacity | Baseline | 
| FEV1/FVC | 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) | 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) | 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) | Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test. | Baseline | 
| Exercise capacity (m) | Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test. | 6 weeks after the start of intervention |