3R Rehabilitation Management of COVID-19 Survivors

NCT ID: NCT04892979

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Centre-based

Centre-based exercise cardiopulmonary rehabilitation program for 6 weeks

Group Type EXPERIMENTAL

Cardiopulmonary exercise (centre-based)

Intervention Type OTHER

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.

Online-based

Online-based exercise cardiopulmonary rehabilitation program for 6 weeks

Group Type EXPERIMENTAL

Cardiopulmonary exercise (online-based)

Intervention Type OTHER

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.

Combined

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

Group Type EXPERIMENTAL

Cardiopulmonary exercise (centre-based)

Intervention Type OTHER

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)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamela Youde Nethersole Eastern Hospital, Hong Kong

UNKNOWN

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Tuen Mun Hospital Hong Kong

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siu Ngor Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Loletta Kit-ying So, MD

Role: PRINCIPAL_INVESTIGATOR

Pamela Youde Eastern Hospital

Locations

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Pamela Youde Eastern Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Siu Ngor Fu, PhD

Role: CONTACT

852-27666726

Facility Contacts

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Loletta So

Role: primary

852-25956411

Yiu Cheong Yeung

Role: primary

Wu Tak Chiu

Role: primary

852-35062049

Yuk Yung Ng

Role: primary

Other Identifiers

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HSEARS20200912001

Identifier Type: -

Identifier Source: org_study_id

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