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|Title:||COVID-19 rehabilitation with herbal medicine and cardiorespiratory exercise : protocol for a clinical study||Authors:||Gao, Y
|Issue Date:||May-2021||Source:||JMIR research protocols, 26 May 2021, v. 10, no. 5, e25556||Abstract:||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.
|Publisher:||JMIR Publications, Inc.||Journal:||JMIR research protocols||EISSN:||1929-0748||DOI:||10.2196/25556||Rights:||©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.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
The following publication Gao Y, Zhong LLD, Quach B, Davies B, Ash GI, Lin Z, 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;10(5):e25556 is available at https://doi.org/10.2196/25556
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