3R Rehabilitation Management of COVID-19 Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Cardiopulmonary exercise (centre-based); Other: Cardiopulmonary exercise (online-based)

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siu Ngor Fu, PhD; Phone Number: 852-27666726; Email: amy.fu@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Pamela Youde Eastern Hospital
    • Contact: Loletta So; Phone Number: 852-25956411; Email: soky@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Princess Margaret Hospital
    • Contact: Yiu Cheong Yeung; Email: yeungyc@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Elizabeth Hospital
    • Contact: Wu Tak Chiu; Phone Number: 852-35062049; Email: wutc@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Tuen Mun Hospital
    • Contact: Yuk Yung Ng; Email: ngyy3@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Centre-based; Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks	Other: 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	Other: 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	Other: 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.; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Pamela Youde Nethersole Eastern Hospital, Hong Kong; Princess Margaret Hospital, Hong Kong; Tuen Mun Hospital Hong Kong
• Investigators: Principal Investigator: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University; Principal Investigator: Loletta Kit-ying So, MD, Pamela Youde Eastern Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HSEARS20200912001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No