Official Title
Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms
Brief Summary

Rehabilitation interventions can help to address the consequences of COVID-19, which include medical, physical, cognitive, and psychological related problems. The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in recovering COVID-19 patients. A further aim will be to examine how Chinese herbal medicines, gut microbiome, and metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.

Detailed Description

The study will develop a new paradigm for patient rehabilitation needed now and in the
future. The specific aims of this project are to investigate the effects of a 12-week program
with cardiorespiratory exercise and Chinese herbal medicine on recovering COVID-19 patients
and to collect qualitative and quantitative data to examine loneliness, anxiety, depression,
quality of life, and mental health. A further aim will be to examine how Chinese herbal
medicines, gut microbiome, and the metabolites regulate immune function, intestinal
permeability, and possibly autoimmune deficiency (AID) in the pathological
recovery/rehabilitation process.

In this multicenter, triple-blinded, randomized, parallel groups, controlled clinical trial,
the investigator will recruit adult patients with COVID-19 and have been discharged from the
hospital in Hong Kong and the Chinese Mainland.

A total of 172 eligible patients will be randomized 1:1:1:1 into four groups:
cardiorespiratory exercise plus Chinese herbal medicines group, cardiorespiratory exercise
group, Chinese herbal medicines group, and waiting list group for 12-week (3 months) with
12-week follow-up period.

A 4-week pilot study will be conducted to test patient recruitment and maintenance, data
collection, instrumentation, and observing the adaptability and practicality of the
intervention. Amendments will be made if necessary.

Unknown status
Coronavirus Disease (COVID-19)

Other: Cardiorespiratory Exercise

Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training

Other: Modified Bai He Gu Jin Tang

The Chinese herbal formula of Modified Bai He Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. Patients will dissolve a sachet of granules (5.0g) in 200ml of hot water, twice a day after breakfast and dinner, seven days a week for three months.

Eligibility Criteria

Inclusion Criteria:

1. aged 18 years and above;

2. a percentage of predicted forced vital capacity (FVC) <90%, and/or a percentage of
predicted carbon monoxide diffusing capacity < 90% (King 2014);

3. able to communicate in Cantonese.

Exclusion Criteria:

1. having acute exacerbations in the 12-week preceding recruitment patients;

2. having any contraindications for exercise (e.g., physical disability, uncontrolled
mental disorders, unstable heart disease, unable to perform muscle strength tests)

3. Female - Pregnant or plan to become pregnant in the next 1 year

4. Unable to communicate in Cantonese or Mandarin

5. Currently participating in other similar rehabilitation programs or research

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

Linda Zhong
Kowloon Tong, Kowloon, Hong Kong

Investigator: Linda Zhong, MD,PhD
Contact: 34116523
ldzhong0305@gmail.com

Contacts

Linda Zhong
852-34116523
ldzhong0305@gmail.com

Zhaoxiang Bian, Ph.D
34112905
bzxiang@hkbu.edu.hk

Julien Baker, Ph.D, D.Sc, Study Chair
Department of Sport, Physical Education and Health, Hong Kong Baptist University

Hong Kong Baptist University
NCT Number
Keywords
Covid-19
Cardiorespiratory Exercise
Chinese medicine
MeSH Terms
COVID-19
Coronavirus Infections