3R Rehabilitation Management of COVID-19 Survivors

May 18, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Pamela Youde Eastern Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
      • Hong Kong, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue measured by Fatigue Assessment Scale
Time Frame: 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
Time Frame: Baseline
The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle strength by 30-second double-leg sit-to-stand test (times)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration
Baseline
Forced vital capacity (l)
Time Frame: 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
Time Frame: Baseline
Ratio of forced expiratory volume in one second and forced vital capacity
Baseline
FEV1/FVC
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline
Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.
Baseline
Exercise capacity (m)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queen Elizabeth Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Tuen Mun Hospital Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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