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

NCT04572360 | Unknown DMC

• 1 other identifier: HKCOVID19Rehab
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease (COVID-19)

Keywords

COVID-19; Cardiorespiratory Exercise; Chinese Medicine

Outcome Measures

Primary Outcomes (19)

• 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

  6 months

• Blood Pressure

  Blood pressure (Systolic/Diastolic) in mmHg will be measured before \& after 6MWT

  6 months

• Heart Rate

  Heart rate in beats per minute will be measured before \& after 6MWT

  6 months

• Peripheral oxygen saturation (SpO2)

  SpO2 in % will be measured before \& after 6MWT

  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

  6 months

• Body composition - Segmental Muscle Mass

  Bio-impedance analysis approach will be used to assess patient's segmental muscle mass in percentage (%).

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  Change from baseline the Body Constitution at 6 months

Secondary Outcomes (8)

• 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 - Depression Anxiety Stress Scale (DASS-21)

  6 months

• Other mental health-related measures - Revised UCLA Loneliness Scale (R-UCLA)

  6 months

Study Arms (4)

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.

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.

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.

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).

Interventions

Cardiorespiratory Exercise OTHER

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

Cardiorespiratory Exercise Group; Cardiorespiratory Exercise plus Chinese Herbal Medicines Group

Modified Bai He Gu Jin Tang OTHER

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.

Cardiorespiratory Exercise plus Chinese Herbal Medicines Group; Chinese Herbal Medicines Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• The University of Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator
• The Hong Kong Polytechnic University: collaborator
• University of South Wales: collaborator
• Yale University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 33970864 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julien Baker, Ph.D, D.Sc

  Department of Sport, Physical Education and Health, Hong Kong Baptist University

  STUDY CHAIR

Central Study Contacts

Linda Zhong

CONTACT

852-34116523; ldzhong0305@gmail.com

Zhaoxiang Bian, Ph.D

CONTACT

34112905; bzxiang@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 1, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year after the completion of study.
• Access Criteria: All researchers can get the information by sending requests to the study contact person.

Locations

HK (1)