3R Rehabilitation Management of COVID-19 Survivors

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892979
• Other study ID #: HSEARS20200912001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2021
• Source: The Hong Kong Polytechnic University
• Contact: Siu Ngor Fu, PhD
• Phone: 852-27666726
• Email: amy.fu[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (5)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Pamela Youde Nethersole Eastern Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Tuen Mun Hospital Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fatigue measured by Fatigue Assessment Scale	The Fatigue Assessment Scale is a 10-item scale evaluating symptoms of chronic fatigue.exercise test.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Forced vital capacity (l)	Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration	Baseline
Secondary	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
Secondary	FEV1/FVC	Ratio of forced expiratory volume in one second and forced vital capacity	Baseline
Secondary	FEV1/FVC	Ratio of forced expiratory volume in one second and forced vital capacity	6 weeks after the start of intervention
Secondary	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
Secondary	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
Secondary	Exercise capacity (m)	Exercise capacity will be assessed by the 6-minute walk test (6MWT), a submaximal exercise test.	Baseline
Secondary	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