Clinical trial NCT04572360: Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients
Official title: Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Disease (COVID-19)
Keywords: COVID-19
Cardiorespiratory Exercise
Chinese Medicine
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Chinese University of Hong Kong
name: The Hong Kong Polytechnic University
name: University of South Wales
name: Yale University
name: University of California, San Diego
First posted: 2020-10-01
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A triple-blinded, randomized, parallel groups, controlled clinical trial. 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Heart Rate
timeFrame: 6 months
measure: Peripheral oxygen saturation (SpO2)
timeFrame: 6 months
measure: Borg Dyspnea Scale
timeFrame: 6 months
measure: Body composition - Segmental Muscle Mass
timeFrame: 6 months
measure: Body composition - Body Mass Index (BMI)
timeFrame: 6 months
measure: Body composition - Anatomical Circumferences
timeFrame: 6 months
measure: FVC (L) in Lung function Test using Spirometry
timeFrame: 6 months
measure: FEV1 (L) in Lung function Test using Spirometry
timeFrame: 6 months
measure: MVV (L/min) in Lung function Test using Spirometry
timeFrame: 6 months
measure: Fractional exhaled Nitric Oxide (FeNO)
timeFrame: 6 months
measure: Diffusing capacity of the lungs for carbon monoxide (DLCO)
timeFrame: 6 months
measure: Cardiopulmonary Exercise Test (CPET) - Work Rate(WR)
timeFrame: 6 months
measure: Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE)
timeFrame: 6 months
measure: Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2)
timeFrame: 6 months
measure: Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2)
timeFrame: 6 months
measure: Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
timeFrame: Change from baseline the CM Diagnostic Pattern & Clinical Characteristics at 6 months
measure: Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
timeFrame: Change from baseline the Body Constitution at 6 months
Secondary outcomes:
measure: Blood Biochemistry Tests - Serum Levels of Insulin (pmol/l)
timeFrame: 6 months
measure: Blood Biochemistry Tests - Prothrombin Time (seconds)
timeFrame: 6 months
measure: Quality of Life - Personal Wellbeing Index - Chinese Version (Adult)
timeFrame: 6 months
measure: Other mental health-related measures - Depression Anxiety Stress Scale (DASS-21)
timeFrame: 6 months
measure: Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA)
timeFrame: 6 months
measure: Other mental health-related measures - General Health Questionnaire (GHQ)
timeFrame: 6 months
measure: Gut microbiome Test
timeFrame: 6 months
measure: Metabolomics-related Measurement of Depression - Metabolomics Analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Department of Sport, Physical Education and Health, Hong Kong Baptist University
name: Julien Baker, Ph.D, D.Sc
role: STUDY_CHAIR
References:
citation: Gao Y, Zhong LLD, Quach B, Davies B, Ash GI, Lin ZX, Feng Y, Lau BWM, Wagner PD, Yang X, Guo Y, Jia W, Bian Z, Baker JS. COVID-19 Rehabilitation With Herbal Medicine and Cardiorespiratory Exercise: Protocol for a Clinical Study. JMIR Res Protoc. 2021 May 26;10(5):e25556. doi: 10.2196/25556.