Coronavirus Disease (COVID-19)Covid19RehNCT04572360
Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients
A study testing Cardiorespiratory Exercise and Modified Bai He Gu Jin Tang in people with Coronavirus Disease (COVID-19), run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- Cardiorespiratory Exercise and Modified Bai He Gu Jin Tang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years and above;
- a percentage of predicted forced vital capacity (FVC) <90%, and/or a percentage of predicted carbon monoxide diffusing capacity < 90% (King 2014);
- able to communicate in Cantonese.
Who cannot join
- having acute exacerbations in the 12-week preceding recruitment patients;
- having any contraindications for exercise (e.g., physical disability, uncontrolled mental disorders, unstable heart disease, unable to perform muscle strength tests)
- Female - Pregnant or plan to become pregnant in the next 1 year
- Unable to communicate in Cantonese or Mandarin
- Currently participating in other similar rehabilitation programs or research
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Linda Zhong
Kowloon Tong, Kowloon
Linda Zhong, MD,PhD, 34116523, ldzhong0305@gmail.com
About this study
Official title: Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms
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.
Read the 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.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- Cardiorespiratory Exercise, Modified Bai He Gu Jin Tang
- Keywords
- COVID-19, Cardiorespiratory Exercise, Chinese Medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory ExerciseOther
Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training
Modified Bai He Gu Jin TangOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiorespiratory Exercise plus Chinese Herbal Medicines Group | Experimental | 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. Receives: Other: Cardiorespiratory Exercise; Other: Modified Bai He Gu Jin Tang |
| Cardiorespiratory Exercise Group | Experimental | 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. Receives: Other: Cardiorespiratory Exercise |
| Chinese Herbal Medicines Group | Experimental | 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. Receives: Other: Modified Bai He Gu Jin Tang |
| Waiting List Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test
To assess the functional exercise capacity that reflects daily physical activities and to measure the distance the participant is able to walk over six minutes on a hard, flat surface.
Items measured during 6MWT are:
- Distance Walked (m)
- Number of Rests
Measured: 6 months
Blood Pressure
Blood pressure (Systolic/Diastolic) in mmHg will be measured before \& after 6MWT
Measured: 6 months
Heart Rate
Heart rate in beats per minute will be measured before \& after 6MWT
Measured: 6 months
Peripheral oxygen saturation (SpO2)
SpO2 in % will be measured before \& after 6MWT
Measured: 6 months
Borg Dyspnea Scale
The Borg Category Ratio 10 (CR10) Scale® (Borg Dyspnea Scale), will be used to rate the patients' dyspnea and overall fatigue level. At the beginning and end the end of the 6 MWT. The scale will also be used during Cardiopulmonary Exercise Test (CPET).
Scale:
0=Rest; 0.5=Really Really Easy; 1=Really Easy; 2=Easy; 3=Moderate; 4=Sort of Hard; 5,6=Hard; 7,8,9=Really Hard; 10=Maximal
Measured: 6 months
Body composition - Segmental Muscle Mass
Bio-impedance analysis approach will be used to assess patient's segmental muscle mass in percentage (%).
Measured: 6 months
Body composition - Body Mass Index (BMI)
A stadiometer will be used to measure stature (in metres) and weight is measured in kg to calculate body mass index (BMI) .
Body Mass Index (BMI): weight (in kilograms) divided by the square of your height (in metres)
Measured: 6 months
Body composition - Anatomical Circumferences
Anatomical circumferences - waist (cm) \& Hip (cm) will be measured using a steel measuring tape, to calculate the Waist-to-Hip Ratio.
Measured: 6 months
FVC (L) in Lung function Test using Spirometry
Forced vital capacity test (FVC) will be measured and used to calculate FEV1/FVC ratio to assess the functional severity and capacity of the patient's lung.
Measured: 6 months
FEV1 (L) in Lung function Test using Spirometry
Forced expiratory volume (FEV1) will be measured and used to calculate FEV1 /FVC ratio to assess the functional severity and capacity of the patient's lung.
Measured: 6 months
MVV (L/min) in Lung function Test using Spirometry
Maximal Voluntary Ventilation (MVV) measures peak performance of the lungs and respiratory muscles to assess overall pulmonary ventilation.
Measured: 6 months
Fractional exhaled Nitric Oxide (FeNO)
Fractional exhaled Nitric Oxide (FeNO), the results will be in parts per billion (ppb) of nitric oxide in patient's breath, will be used to assess inflammatory response to exercise and medicinal intervention.
Measured: 6 months
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Diffusing capacity of the lungs for carbon monoxide (DLCO), measured in millilitre/minute/Kilopascal (ml/min/kPa), will be used to evaluate gas diffusion in the lungs.
Measured: 6 months
Cardiopulmonary Exercise Test (CPET) - Work Rate(WR)
CPET provides information concerning the level of exercise that the patient can perform without undue stress. The test results will guide the research team regarding exercise prescription for physical rehabilitation methodologies, and provides quantitative evidence of the benefits of a rehabilitation program as well as information on the mechanism(s) involved.
Work Rate(WR), an incremental ergometry exercise test, will be used to assess the cellular, cardiovascular, and ventilatory systems' responses under precise conditions of metabolic stress
Measured: 6 months
Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE)
Breath by breath measurements of minute ventilation (VE) in L/min will be measured and used to calculate ventilatory efficiency - VE/VCO2 and VE/VO2, ventilatory equivalents for carbon dioxide and oxygen.
Measured: 6 months
Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2)
CO2 output (VCO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VCO2, ventilatory equivalents for carbon dioxide.
Measured: 6 months
Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2)
O2 uptake (VO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VO2, ventilatory equivalents for oxygen.
Measured: 6 months
Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
The changes in participants' health as characterized by CM diagnostic pattern \& clinical characteristics using CM Syndrome Differentiation according to the Guidelines for Chinese Medicine New Drug Clinical Study (China Medical Science Press, 2002) will be assessed.
Measured: Change from baseline the CM Diagnostic Pattern & Clinical Characteristics at 6 months
Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
The changes in participants' health as characterized by body constitution scores using the Body Constitution Questionnaires for the nine specific types of body constitutions will be assessed on each visit during the treatment and follow up period.
Measured: Change from baseline the Body Constitution at 6 months
Secondary outcomes (8)
Blood Biochemistry Tests - Serum Levels of Insulin (pmol/l)
Venous blood will be drawn \& after coagulation at room temperature for 30 minutes, the samples will be centrifuged at 3000 rpm for 20 minutes. Serum as supernatant will be extracted \& stored at -80˚C until assay. Serum levels of insulin will be assessed by a commercially available Enzyme-linked immunosorbent Assay (ELISA) kit (Merck).
Measured: 6 months
Blood Biochemistry Tests - Prothrombin Time (seconds)
The Prothrombin time test will be used to measure blood coagulation. Venous blood will be collected by venepuncture in a tube with sodium citrate. Plasma will be isolated after centrifugation at 1000rpm for 30 min, 4°C. Thromboplastin will be added into the plasma and kept at 37°C for two minutes. Calcium chloride will be added to the mixture, and the plasma is allowed to coagulate. The time needed for the coagulation will be recorded as the Prothrombin Time.
Measured: 6 months
Quality of Life - Personal Wellbeing Index - Chinese Version (Adult)
Quality of life (QoL) will be measured using the Personal Well-being Index-Chinese Version (PWI-C). It is a subjective QoL measure with questionnaires that have been translated and validated.
Questions included are:
How satisfied are you with…?"
- your standard of living ?
- your health ?
- what you are achieving in life ?
- your personal relationships ?
- how safe you feel ?
- feeling part of your community ?
- your future security ?
Answers are measured using scale from zero to 10 (0...1…2...3...4…5...6...7...8...9…10).
Zero means feel no satisfaction at all; 10 means feel completely satisfied.
Measured: 6 months
Other mental health-related measures - Depression Anxiety Stress Scale (DASS-21)
Anxiety and stress will be measured using the Chinese version of the Depression Anxiety Stress Scale (DASS-21). The scale will discriminate between the negative emotional syndromes of depression, anxiety, and stress in Chinese populations. Only the subscales of anxiety and stress will be used.
The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive \& impatient.
The rating scale is as follows:
0=Did not apply to me at all
- Applied to me to some degree, or some of the time
- Applied to me to a considerable degree or a good part of time
- Applied to me very much or most of the time
Scores are calculated by summing the scores for the relevant items. Higher scores indicate greater degrees of anxiety and stress.
Measured: 6 months
Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA)
Loneliness will be measured using the Revised UCLA Loneliness Scale (R-UCLA). It consists of 20 items and participants are to indicate how often they feel the way described by placing a check in the space provided, using the following scale:
- Never
- Rarely
- Sometimes
- Often
Score scale for item 1,5,6,9,10,15,16,19,20 are reversed, and score for each item then summed together. Higher scores indicate greater degrees of loneliness.
Measured: 6 months
Other mental health-related measures - General Health Questionnaire (GHQ)
General mental health will be measured using the General Health Questionnaire (GHQ), which is commonly used to screen minor psychiatric symptoms (Hu 2007).
It consists of 12 items, beginning by asking "Have you recently…", each assessing the severity of a mental problem over the past few weeks using a 4-point scale of: (always) 0...1…2…3 (never).
The score was used to generate a total score ranging from 0 to 36, with higher scores indicating worse conditions.
Measured: 6 months
Gut microbiome Test
Patient is to self-sample morning first feces \& immediately freeze it in a home freezer (-20℃) \& transport to facilities in a provided freezer pack stored at -80℃. Total DNA of 200 mg fecal samples will be extracted \& purified. The DNA concentration \& size distribution will be estimated by a Nano drop instrument \& agarose gel electrophoresis respectively. The DNA one paired-end (PE) library will be prepared using a DNA high-throughput (HT) Sample Prep Kit, \& whole-genome shotgun sequencing of samples will be carried out by the Illumina platform. The high quality sequences will be mapped with the published gene catalog of reference genes in the human gut microbiome (Li 2014). Taxonomic assignment of the predicted genes and Kyoto Encyclopedia of Genes \& Genomes (KEGG) analysis will be performed as described (Feng 2015). Relative abundances of phyla, genera, species, \& Kegg Orthology (KOs) will be calculated from the relative abundances of the respective genes.
Measured: 6 months
Metabolomics-related Measurement of Depression - Metabolomics Analysis
Metabolomics analysis of selected neurotransmitters as potential markers of depression: Ultra-performance liquid chromatography triple quadrupole mass spectrometry will be used to quantitatively measure the metabolites selected (neurotransmitters) as potential markers of depression. Briefly, an aliquot of 40 μl of urine or plasma will be spiked with 10 μL of internal standard (L-4-chlorophenylalanine in water, 30 μg/mL), and extracted with 200 μL of acetonitrile and methanol (9:1, v/v). The mixture will be vortexed and centrifuged. After centrifugation, the supernatant will be transferred to the sampling vials and subject to analysis. The raw data generated will be processed using the Target Lynx Applications Manager Version 4.1 (Waters Corp., Milford, MA) for targeted metabolite annotation and to obtain calibration equations and the concentration of each metabolite in the samples Metabolomics analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong, The Hong Kong Polytechnic University, University of South Wales, Yale University, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Julien Baker, Ph.D, D.Sc, Study chair, Department of Sport, Physical Education and Health, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572360
- Sponsor's protocol ID
- HKCOVID19Rehab
- Acronym
- Covid19Reh
- Status last verified
- Jun 2021
- First submitted
- 27 Sep 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial will be deidentified and available for anyone who wish to access the data immediately following publication.
Publications
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.
PubMed 33970864
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms
- ClinicalTrials.gov ID
- NCT04572360
- Acronym / sponsor ID
- Covid19Reh / HKCOVID19Rehab
- Conditions
- Coronavirus Disease (COVID-19)
- Keywords
- COVID-19, Cardiorespiratory Exercise, Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Chinese University of Hong Kong, The Hong Kong Polytechnic University, University of South Wales, Yale University, University of California, San Diego
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cardiorespiratory Exercise plus Chinese Herbal Medicines Group | Experimental | Other: Cardiorespiratory Exercise, Other: Modified Bai He Gu Jin TangIncludes: 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. |
| Cardiorespiratory Exercise Group | Experimental | Other: Cardiorespiratory ExerciseIncludes: 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. |
| Chinese Herbal Medicines Group | Experimental | Other: Modified Bai He Gu Jin TangIncludes: 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. |
| Waiting List Group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years and above;
- a percentage of predicted forced vital capacity (FVC) <90%, and/or a percentage of predicted carbon monoxide diffusing capacity < 90% (King 2014);
- able to communicate in Cantonese.
Key exclusion criteria (5 listed)
- having acute exacerbations in the 12-week preceding recruitment patients;
- having any contraindications for exercise (e.g., physical disability, uncontrolled mental disorders, unstable heart disease, unable to perform muscle strength tests)
- Female - Pregnant or plan to become pregnant in the next 1 year
- Unable to communicate in Cantonese or Mandarin
- Currently participating in other similar rehabilitation programs or research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory ExerciseEach exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training | Other | Cardiorespiratory Exercise Group, Cardiorespiratory Exercise plus Chinese Herbal Medicines Group |
| Modified Bai He Gu Jin TangThe 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. | Other | Cardiorespiratory Exercise plus Chinese Herbal Medicines Group, Chinese Herbal Medicines Group |
Primary outcome
Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test
Time frame: 6 months
To assess the functional exercise capacity that reflects daily physical activities and to measure the distance the participant is able to walk over six minutes on a hard, flat surface. Items measured during 6MWT are: * Distance Walked (m) * Number of Rests
Blood Pressure
Time frame: 6 months
Blood pressure (Systolic/Diastolic) in mmHg will be measured before \& after 6MWT
Heart Rate
Time frame: 6 months
Heart rate in beats per minute will be measured before \& after 6MWT
Peripheral oxygen saturation (SpO2)
Time frame: 6 months
SpO2 in % will be measured before \& after 6MWT
Borg Dyspnea Scale
Time frame: 6 months
The Borg Category Ratio 10 (CR10) Scale® (Borg Dyspnea Scale), will be used to rate the patients' dyspnea and overall fatigue level. At the beginning and end the end of the 6 MWT. The scale will also be used during Cardiopulmonary Exercise Test (CPET). Scale: 0=Rest; 0.5=Really Really Easy; 1=Really Easy; 2=Easy; 3=Moderate; 4=Sort of Hard; 5,6=Hard; 7,8,9=Really Hard; 10=Maximal
Body composition - Segmental Muscle Mass
Time frame: 6 months
Bio-impedance analysis approach will be used to assess patient's segmental muscle mass in percentage (%).
Body composition - Body Mass Index (BMI)
Time frame: 6 months
A stadiometer will be used to measure stature (in metres) and weight is measured in kg to calculate body mass index (BMI) . Body Mass Index (BMI): weight (in kilograms) divided by the square of your height (in metres)
Body composition - Anatomical Circumferences
Time frame: 6 months
Anatomical circumferences - waist (cm) \& Hip (cm) will be measured using a steel measuring tape, to calculate the Waist-to-Hip Ratio.
FVC (L) in Lung function Test using Spirometry
Time frame: 6 months
Forced vital capacity test (FVC) will be measured and used to calculate FEV1/FVC ratio to assess the functional severity and capacity of the patient's lung.
FEV1 (L) in Lung function Test using Spirometry
Time frame: 6 months
Forced expiratory volume (FEV1) will be measured and used to calculate FEV1 /FVC ratio to assess the functional severity and capacity of the patient's lung.
MVV (L/min) in Lung function Test using Spirometry
Time frame: 6 months
Maximal Voluntary Ventilation (MVV) measures peak performance of the lungs and respiratory muscles to assess overall pulmonary ventilation.
Fractional exhaled Nitric Oxide (FeNO)
Time frame: 6 months
Fractional exhaled Nitric Oxide (FeNO), the results will be in parts per billion (ppb) of nitric oxide in patient's breath, will be used to assess inflammatory response to exercise and medicinal intervention.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: 6 months
Diffusing capacity of the lungs for carbon monoxide (DLCO), measured in millilitre/minute/Kilopascal (ml/min/kPa), will be used to evaluate gas diffusion in the lungs.
Cardiopulmonary Exercise Test (CPET) - Work Rate(WR)
Time frame: 6 months
CPET provides information concerning the level of exercise that the patient can perform without undue stress. The test results will guide the research team regarding exercise prescription for physical rehabilitation methodologies, and provides quantitative evidence of the benefits of a rehabilitation program as well as information on the mechanism(s) involved. Work Rate(WR), an incremental ergometry exercise test, will be used to assess the cellular, cardiovascular, and ventilatory systems' responses under precise conditions of metabolic stress
Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE)
Time frame: 6 months
Breath by breath measurements of minute ventilation (VE) in L/min will be measured and used to calculate ventilatory efficiency - VE/VCO2 and VE/VO2, ventilatory equivalents for carbon dioxide and oxygen.
Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2)
Time frame: 6 months
CO2 output (VCO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VCO2, ventilatory equivalents for carbon dioxide.
Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2)
Time frame: 6 months
O2 uptake (VO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VO2, ventilatory equivalents for oxygen.
Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
Time frame: Change from baseline the CM Diagnostic Pattern & Clinical Characteristics at 6 months
The changes in participants' health as characterized by CM diagnostic pattern \& clinical characteristics using CM Syndrome Differentiation according to the Guidelines for Chinese Medicine New Drug Clinical Study (China Medical Science Press, 2002) will be assessed.
Change in Body Constitution Scores using Body Constitution Questionnaires Assessment
Time frame: Change from baseline the Body Constitution at 6 months
The changes in participants' health as characterized by body constitution scores using the Body Constitution Questionnaires for the nine specific types of body constitutions will be assessed on each visit during the treatment and follow up period.
8 secondary outcomes
Blood Biochemistry Tests - Serum Levels of Insulin (pmol/l)
Time frame: 6 months
Blood Biochemistry Tests - Prothrombin Time (seconds)
Time frame: 6 months
Quality of Life - Personal Wellbeing Index - Chinese Version (Adult)
Time frame: 6 months
Other mental health-related measures - Depression Anxiety Stress Scale (DASS-21)
Time frame: 6 months
Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA)
Time frame: 6 months
Other mental health-related measures - General Health Questionnaire (GHQ)
Time frame: 6 months
Gut microbiome Test
Time frame: 6 months
Metabolomics-related Measurement of Depression - Metabolomics Analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Derived from this study: PubMed 33970864Gao 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.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial will be deidentified and available for anyone who wish to access the data immediately following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Baker, Ph.D, D.Sc study chair
Department of Sport, Physical Education and Health, Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory Exercise and Modified Bai He Gu Jin Tang in people with Coronavirus Disease (COVID-19), run by Hong Kong Baptist University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Zhong (852-34116523, ldzhong0305@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test (time frame: 6 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.