PMID- 33970864
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210920
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 5
DP  - 2021 May 26
TI  - COVID-19 Rehabilitation With Herbal Medicine and Cardiorespiratory Exercise: 
      Protocol for a Clinical Study.
PG  - e25556
LID - 10.2196/25556 [doi]
LID - e25556
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 alpha 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.
CI  - (c)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.
FAU - Gao, Yang
AU  - Gao Y
AUID- ORCID: 0000-0003-0439-4804
AD  - Centre for Health and Exercise Science Research, Hong Kong Baptist University, 
      Kowloon, Hong Kong.
FAU - Zhong, Linda L D
AU  - Zhong LLD
AUID- ORCID: 0000-0002-3877-1914
AD  - School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong.
AD  - Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 
      Kowloon, Hong Kong.
FAU - Quach, Binh
AU  - Quach B
AUID- ORCID: 0000-0002-2500-0301
AD  - Centre for Health and Exercise Science Research, Hong Kong Baptist University, 
      Kowloon, Hong Kong.
FAU - Davies, Bruce
AU  - Davies B
AUID- ORCID: 0000-0002-0007-9535
AD  - Neurovascular Research Laboratory, University of South Wales, Pontypridd, United 
      Kingdom.
FAU - Ash, Garrett I
AU  - Ash GI
AUID- ORCID: 0000-0002-8655-7525
AD  - Veterans Affairs Connecticut Healthcare System, West Haven, CT, United States.
AD  - Center for Medical Informatics, Yale University, New Haven, CT, United States.
FAU - Lin, Zhi-Xiu
AU  - Lin ZX
AUID- ORCID: 0000-0003-2840-6179
AD  - School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong 
      Kong, New Territories, Hong Kong.
FAU - Feng, Yibin
AU  - Feng Y
AUID- ORCID: 0000-0002-0241-670X
AD  - School of Chinese Medicine, The University of Hong Kong, Hong Kong, Hong Kong.
FAU - Lau, Benson W M
AU  - Lau BWM
AUID- ORCID: 0000-0002-4552-2780
AD  - Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, 
      Kowloon, Hong Kong.
FAU - Wagner, Peter D
AU  - Wagner PD
AUID- ORCID: 0000-0001-7957-7432
AD  - Department of Medicine, University of California San Diego, La Jolla, CA, United 
      States.
FAU - Yang, Xian
AU  - Yang X
AUID- ORCID: 0000-0002-1496-8923
AD  - Department of Computer Science, Hong Kong Baptist University, Kowloon, Hong Kong.
FAU - Guo, Yike
AU  - Guo Y
AUID- ORCID: 0000-0002-3075-2161
AD  - Department of Computer Science, Hong Kong Baptist University, Kowloon, Hong Kong.
FAU - Jia, Wei
AU  - Jia W
AUID- ORCID: 0000-0002-3739-8994
AD  - School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong.
AD  - Center for Translational Medicine and Shanghai Key Laboratory of Diabetes 
      Mellitus, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 
      Shanghai, China.
FAU - Bian, Zhaoxiang
AU  - Bian Z
AUID- ORCID: 0000-0001-6206-1958
AD  - School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong.
AD  - Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 
      Kowloon, Hong Kong.
FAU - Baker, Julien S
AU  - Baker JS
AUID- ORCID: 0000-0001-7896-6217
AD  - Centre for Health and Exercise Science Research, Hong Kong Baptist University, 
      Kowloon, Hong Kong.
LA  - eng
SI  - ClinicalTrials.gov/NCT04572360
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20210526
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8158531
OTO - NOTNLM
OT  - COVID-19
OT  - Chinese medicine
OT  - cardiorespiratory exercise
OT  - rehabilitation
COIS- Conflicts of Interest: None declared.
EDAT- 2021/05/11 06:00
MHDA- 2021/05/11 06:01
PMCR- 2021/05/26
CRDT- 2021/05/10 17:58
PHST- 2020/11/09 00:00 [received]
PHST- 2021/04/12 00:00 [accepted]
PHST- 2021/02/22 00:00 [revised]
PHST- 2021/05/11 06:00 [pubmed]
PHST- 2021/05/11 06:01 [medline]
PHST- 2021/05/10 17:58 [entrez]
PHST- 2021/05/26 00:00 [pmc-release]
AID - v10i5e25556 [pii]
AID - 10.2196/25556 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 May 26;10(5):e25556. doi: 10.2196/25556.