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3R Rehabilitation Management of COVID-19 Survivors

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cardiopulmonary exercise (centre-based)
Cardiopulmonary exercise (online-based)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamela Youde Eastern HospitalRecruiting
  • Princess Margaret HospitalRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Tuen Mun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Centre-based

Online-based

Combined

Arm Description

Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks

Online-based exercise cardiopulmonary rehabilitation program for 6 weeks

Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks

Outcomes

Primary Outcome Measures

Fatigue measured by Fatigue Assessment Scale
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Fatigue measured by Fatigue Assessment Scale
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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.
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.
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
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
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
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
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
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
Forced vital capacity (l)
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
Forced vital capacity (l)
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
FEV1/FVC
Ratio of forced expiratory volume in one second and forced vital capacity
FEV1/FVC
Ratio of forced expiratory volume in one second and forced vital capacity
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
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
Exercise capacity (m)
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
Exercise capacity (m)
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.

Full Information

First Posted
March 1, 2021
Last Updated
May 18, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Pamela Youde Nethersole Eastern Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong, Tuen Mun Hospital Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04892979
Brief Title
3R Rehabilitation Management of COVID-19 Survivors
Official Title
3R Rehabilitation Management of COVID-19 Survivors Using Centre-based and Online-based Approaches
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Pamela Youde Nethersole Eastern Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong, Tuen Mun Hospital Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Centre-based
Arm Type
Experimental
Arm Description
Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks
Arm Title
Online-based
Arm Type
Experimental
Arm Description
Online-based exercise cardiopulmonary rehabilitation program for 6 weeks
Arm Title
Combined
Arm Type
Experimental
Arm Description
Combined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise (centre-based)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise (online-based)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue measured by Fatigue Assessment Scale
Description
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Time Frame
6 weeks after the start of intervention
Title
Fatigue measured by Fatigue Assessment Scale
Description
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Muscle strength by 30-second double-leg sit-to-stand test (times)
Description
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.
Time Frame
Baseline
Title
Muscle strength by 30-second double-leg sit-to-stand test (times)
Description
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.
Time Frame
6 weeks after the start of intervention
Title
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
Description
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.
Time Frame
Baseline
Title
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
Description
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.
Time Frame
6 weeks after the start of intervention
Title
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
Description
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).
Time Frame
Baseline
Title
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
Description
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).
Time Frame
6 weeks after the start of intervention
Title
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
Description
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
Time Frame
Baseline
Title
Self-perceived quality of life by The Hong Kong Chinese version Short Form-36
Description
The Hong Kong Chinese version Short Form-36 is a concise 36-item health status questionnaire with good psychometric properties.
Time Frame
6 weeks after the start of intervention
Title
Cardiac output (L/min)
Description
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
Time Frame
Baseline
Title
Cardiac output (L/min)
Description
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
Time Frame
6 weeks after the start of intervention
Title
Cardiac stroke volume (ml/m2)
Description
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
Time Frame
Baseline
Title
Cardiac stroke volume (ml/m2)
Description
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
Time Frame
6 weeks after the start of intervention
Title
Forced expiratory volume in one second (l)
Description
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
Time Frame
Baseline
Title
Forced expiratory volume in one second (l)
Description
FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration
Time Frame
6 weeks after the start of intervention
Title
Forced vital capacity (l)
Description
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
Time Frame
Baseline
Title
Forced vital capacity (l)
Description
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
Time Frame
6 weeks after the start of intervention
Title
FEV1/FVC
Description
Ratio of forced expiratory volume in one second and forced vital capacity
Time Frame
Baseline
Title
FEV1/FVC
Description
Ratio of forced expiratory volume in one second and forced vital capacity
Time Frame
6 weeks after the start of intervention
Title
Peak expiratory flow rate (l/s)
Description
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
Time Frame
Baseline
Title
Peak expiratory flow rate (l/s)
Description
Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration
Time Frame
6 weeks after the start of intervention
Title
Exercise capacity (m)
Description
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
Time Frame
Baseline
Title
Exercise capacity (m)
Description
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
Time Frame
6 weeks after the start of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siu Ngor Fu, PhD
Phone
852-27666726
Email
amy.fu@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu Ngor Fu, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loletta Kit-ying So, MD
Organizational Affiliation
Pamela Youde Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Eastern Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loletta So
Phone
852-25956411
Email
soky@ha.org.hk
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiu Cheong Yeung
Email
yeungyc@ha.org.hk
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Tak Chiu
Phone
852-35062049
Email
wutc@ha.org.hk
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuk Yung Ng
Email
ngyy3@ha.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

3R Rehabilitation Management of COVID-19 Survivors

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