Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 9, 2020
Date Accepted: Apr 12, 2021
Date Submitted to PubMed: May 10, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A clinical study protocol for COVID-19 rehabilitation with herbal medicine and cardiorespiratory exercise
ABSTRACT
Background:
Recent studies revealed that most discharged patients with COVID-19 suffered ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19. These include medically, physically, cognitively and psychologically related problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital.
Objective:
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 its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.
Methods:
In this triple-blinded, randomized, parallel groups, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from the hospital in Hong Kong and are suffering from 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 alpha level of 0.05 (two-tailed).
Results:
The trial has not been recruiting patients. The proposed study will be completed in 24 months from 01 Jan 2021 to 31 Dec 2022.
Conclusions:
NA Clinical Trial: ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.