Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms
试验速览
- 阶段
- 不适用
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both patients and investigators will be blinded to the assigned groups. Patients will be allocated at a ratio of 1:1:1:1, the randomization will be carried out by Statistical Analysis System 9.3 (SAS 9.3) statistical software. (Descript how the blinding works here) One copy of the blind codes will be held by the project responsible unit. The statistician will be blinded throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test
时间窗: 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
Borg Dyspnea Scale
时间窗: 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
Blood Pressure
时间窗: 6 months
Blood pressure (Systolic/Diastolic) in mmHg will be measured before \& after 6MWT
Body composition - Anatomical Circumferences
时间窗: 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
时间窗: 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.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
时间窗: 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.
Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment
时间窗: 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.
Heart Rate
时间窗: 6 months
Heart rate in beats per minute will be measured before \& after 6MWT
Peripheral oxygen saturation (SpO2)
时间窗: 6 months
SpO2 in % will be measured before \& after 6MWT
Body composition - Body Mass Index (BMI)
时间窗: 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 - Segmental Muscle Mass
时间窗: 6 months
Bio-impedance analysis approach will be used to assess patient's segmental muscle mass in percentage (%).
Cardiopulmonary Exercise Test (CPET) - Work Rate(WR)
时间窗: 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)
时间窗: 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)
时间窗: 6 months
CO2 output (VCO2) in L/min, will be measured and used to calculate ventilatory efficiency - VE/VCO2, ventilatory equivalents for carbon dioxide.
FEV1 (L) in Lung function Test using Spirometry
时间窗: 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
时间窗: 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)
时间窗: 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.
Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2)
时间窗: 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 Body Constitution Scores using Body Constitution Questionnaires Assessment
时间窗: 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.
次要结局
- Blood Biochemistry Tests - Serum Levels of Insulin (pmol/l)(6 months)
- Blood Biochemistry Tests - Prothrombin Time (seconds)(6 months)
- Quality of Life - Personal Wellbeing Index - Chinese Version (Adult)(6 months)
- Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA)(6 months)
- Other mental health-related measures - Depression Anxiety Stress Scale (DASS-21)(6 months)
- Other mental health-related measures - General Health Questionnaire (GHQ)(6 months)
- Gut microbiome Test(6 months)
- Metabolomics-related Measurement of Depression - Metabolomics Analysis(6 months)