Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients (Covid19Reh)

Hong Kong Baptist University

Status: Unknown

Conditions: Coronavirus Disease (COVID-19)

Treatments: Other: Cardiorespiratory Exercise; Other: Modified Bai He Gu Jin Tang

Study type: Interventional

Funder types: Other

Identifiers

NCT04572360

HKCOVID19Rehab

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 4 patient groups

Cardiorespiratory Exercise plus Chinese Herbal Medicines Group

Experimental group

Description:

Includes: 1.12-week progressive \& individualized exercise, 60mins/session, 3 sessions/week, total 36 exercise sessions. Components: a set of home-based tele-exercise sessions with remote monitoring of vital signs; individualized action plan to perform various daily physical activities; educational sessions on self-management \& habit formation; access to a call center; \& counselling sessions to enhance motivation to regularly engage in daily physical activities. 2.Chinese herbal formula of Modified Bai He Gu Jin Tang prescribed in granules, 10g/day (5g dissolved in 200ml of hot water, b.i.d), twice/day after breakfast \& dinner, 7days/week for 12 weeks.

Treatment:

Other: Cardiorespiratory Exercise

Other: Modified Bai He Gu Jin Tang

Cardiorespiratory Exercise Group

Experimental group

Description:

Includes: A 12-week progressive \& individualized exercise, 60mins/session, 3 sessions/week, total 36 exercise sessions. Components: a set of home-based tele-exercise sessions with remote monitoring of vital signs; individualized action plan to perform various daily physical activities; educational sessions on self-management \& habit formation; access to a call center; \& counselling sessions to enhance motivation to regularly engage in daily physical activities.

Treatment:

Other: Cardiorespiratory Exercise

Chinese Herbal Medicines Group

Experimental group

Description:

Includes: Chinese herbal formula of Modified Bai He Gu Jin Tang prescribed in granules, 10g/day (5g dissolved in 200ml of hot water, b.i.d), twice/day after breakfast \& dinner, 7days/week for 12 weeks.

Treatment:

Other: Modified Bai He Gu Jin Tang

Waiting List Group

No Intervention group

Description:

The waiting list control sign will be adopted to conceal allocation results from the patients and further to reduce selection and confounding bias and increase their adherence to the study. Patients in the waiting list control group will receive no treatment in the study period (including a 12-week intervention period and a 12-week follow-up period). However, they will receive Chinese herbal medicines after the completion of the study (i.e., after the 3rd wave of measurements in the 25th weeks).