A clinical study protocol for COVID-19 rehabilitation with herbal medicine and cardiorespiratory exercise.
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.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.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).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 not been recruiting patients. The data collection will be completed in 24 months from 01 January 2021 to 31 December 2022.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 in COVID-19 rehabilitation.ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360.
Authors: Yang Gao, Lidan 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