3R Rehabilitation Management of COVID-19 Survivors
1 other identifier
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Oct 2020
Typical duration for not_applicable covid19
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 19, 2021
February 1, 2021
1.5 years
March 1, 2021
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (22)
Muscle strength by 30-second double-leg sit-to-stand test (times)
Baseline
Muscle strength by 30-second double-leg sit-to-stand test (times)
6 weeks after the start of intervention
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
Baseline
Self-efficacy by 6-Item Chronic Disease Self-Efficacy scale
6 weeks after the start of intervention
Self-perceived quality of life by The St. George's Respiratory Questionnaire-HK version
Baseline
- +17 more secondary outcomes
Study Arms (3)
Centre-based
EXPERIMENTALCentre-based exercise cardiopulmonary rehabilitation program for 6 weeks
Online-based
EXPERIMENTALOnline-based exercise cardiopulmonary rehabilitation program for 6 weeks
Combined
EXPERIMENTALCombined centre- and online-based exercise cardiopulmonary rehabilitation program for 6 weeks
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having contraindications to exercise
- Physical Activity Readiness Questionnaire (PAR-Q) reveals unsafety
- Cannot understand Cantonese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- Pamela Youde Nethersole Eastern Hospital, Hong Kongcollaborator
- Queen Elizabeth Hospital, Hong Kongcollaborator
- Princess Margaret Hospital, Hong Kongcollaborator
- Tuen Mun Hospital Hong Kongcollaborator
Study Sites (4)
Pamela Youde Eastern Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siu Ngor Fu, PhD
The Hong Kong Polytechnic University
- PRINCIPAL INVESTIGATOR
Loletta Kit-ying So, MD
Pamela Youde Eastern Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
May 19, 2021
Study Start
October 1, 2020
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
May 19, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share