TY - JOUR
T1 - COVID-19 rehabilitation with herbal medicine and cardiorespiratory exercise
T2 - Protocol for a clinical study
AU - Gao, Yang
AU - Zhong, Linda L D
AU - Quach, Binh
AU - Davies, Bruce
AU - Ash, Garrett I.
AU - Lin, Zhi-Xiu
AU - Feng, Yibin
AU - Lau, Benson W.M.
AU - Wagner, Peter D.
AU - Yang, Xian
AU - Guo, Yike
AU - Jia, Wei
AU - Bian, Zhaoxiang
AU - Baker, Julien S.
N1 - Funding Information:
We are thankful to the participants for their participation. This study is supported by the Tsang Shiu Tim Charitable Foundation. The funding source played no role in the study design, collection, management, analysis, interpretation of data, writing of the report, or decision to submit the report for publication.
Publisher Copyright:
© 2021 JMIR Research Protocols.
©Yang Gao, Linda L D Zhong, Binh Quach, Bruce Davies, Garrett I Ash, Zhi-Xiu Lin, Yibin Feng, Benson W M Lau, Peter D Wagner, Xian Yang, Yike Guo, Wei Jia, Zhaoxiang Bian, Julien S Baker. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.05.2021.
PY - 2021/5/26
Y1 - 2021/5/26
N2 - BACKGROUND: Recent studies have revealed that many discharged patients with COVID-19 experience ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19, including medical, physical, cognitive, and psychological problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital for patients with COVID-19.OBJECTIVE: The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in patients recovering from COVID-19. A further aim will be to examine how Chinese herbal medicines as well as the gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.METHODS: In this triple-blinded, randomized, parallel-group, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from hospital in Hong Kong and are experiencing impaired lung function and pulmonary function. A total of 172 eligible patients will be randomized into four equal groups: (1) cardiorespiratory exercise plus Chinese herbal medicines group, (2) cardiorespiratory exercise only group, (3) Chinese herbal medicines only group, and (4) waiting list group (in which participants will receive Chinese herbal medicines after 24 weeks). These treatments will be administered for 12 weeks, with a 12-week follow-up period. Primary outcomes include dyspnea, fatigue, lung function, pulmonary function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry. Measurements will be recorded prior to initiating the above treatments and repeated at the 13th and 25th weeks of the study. The primary analysis is aimed at comparing the outcomes between groups throughout the study period with an α level of .05 (two-tailed).RESULTS: The trial has been approved by the university ethics committee following the Declaration of Helsinki (approval number: REC/19-20/0504) in 2020. The trial has been recruiting patients. The data collection will be completed in 24 months, from January 1, 2021, to December 31, 2022.CONCLUSIONS: Given that COVID-19 and its sequelae would persist in human populations, important findings from this study would provide valuable insights into the mechanisms and processes of COVID-19 rehabilitation.TRIAL REGISTRATION: ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25556.
AB - BACKGROUND: Recent studies have revealed that many discharged patients with COVID-19 experience ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19, including medical, physical, cognitive, and psychological problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital for patients with COVID-19.OBJECTIVE: The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in patients recovering from COVID-19. A further aim will be to examine how Chinese herbal medicines as well as the gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.METHODS: In this triple-blinded, randomized, parallel-group, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from hospital in Hong Kong and are experiencing impaired lung function and pulmonary function. A total of 172 eligible patients will be randomized into four equal groups: (1) cardiorespiratory exercise plus Chinese herbal medicines group, (2) cardiorespiratory exercise only group, (3) Chinese herbal medicines only group, and (4) waiting list group (in which participants will receive Chinese herbal medicines after 24 weeks). These treatments will be administered for 12 weeks, with a 12-week follow-up period. Primary outcomes include dyspnea, fatigue, lung function, pulmonary function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry. Measurements will be recorded prior to initiating the above treatments and repeated at the 13th and 25th weeks of the study. The primary analysis is aimed at comparing the outcomes between groups throughout the study period with an α level of .05 (two-tailed).RESULTS: The trial has been approved by the university ethics committee following the Declaration of Helsinki (approval number: REC/19-20/0504) in 2020. The trial has been recruiting patients. The data collection will be completed in 24 months, from January 1, 2021, to December 31, 2022.CONCLUSIONS: Given that COVID-19 and its sequelae would persist in human populations, important findings from this study would provide valuable insights into the mechanisms and processes of COVID-19 rehabilitation.TRIAL REGISTRATION: ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25556.
KW - Cardiorespiratory exercise
KW - Chinese medicine
KW - COVID-19
KW - Rehabilitation
UR - http://www.scopus.com/inward/record.url?scp=85106947590&partnerID=8YFLogxK
U2 - 10.2196/25556
DO - 10.2196/25556
M3 - Journal article
C2 - 33970864
AN - SCOPUS:85106947590
SN - 1929-0748
VL - 10
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 5
M1 - e25556
ER -
