Gao Yang, Zhong Linda L D, Quach Binh, Davies Bruce, Ash Garrett I, Lin Zhi-Xiu, Feng Yibin, Lau Benson W M, Wagner Peter D, Yang Xian, Guo Yike, Jia Wei, Bian Zhaoxiang, Baker Julien S
Centre for Health and Exercise Science Research, Hong Kong Baptist University, Kowloon, Hong Kong.
School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong.
JMIR Res Protoc. 2021 May 26;10(5):e25556. doi: 10.2196/25556.
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.
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.
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).
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.
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.
ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25556.
近期研究表明，许多新冠肺炎出院患者在数月后仍有持续症状。康复干预有助于应对新冠肺炎的后果，包括医学、身体、认知和心理问题。据我们所知，尚无研究调查新冠肺炎患者出院后康复治疗的效果。
本项目的具体目标是研究一项为期12周的运动计划对新冠肺炎康复患者肺纤维化的影响。另一个目标是研究中药以及肠道微生物群及其代谢产物在康复过程中如何调节免疫功能以及可能存在的自身免疫缺陷。
在这项三盲、随机、平行组、对照临床试验中，我们将招募香港已出院且肺功能和呼吸功能受损的成年新冠肺炎患者。总共172名符合条件的患者将被随机分为四组：（1）心肺运动加中药组；（2）仅心肺运动组；（3）仅中药组；（4）等待名单组（参与者将在24周后接受中药治疗）。这些治疗将持续12周，并进行12周的随访。主要结局包括呼吸困难、疲劳、肺功能、呼吸功能、血氧水平、免疫功能、凝血及相关血液生化指标。测量将在开始上述治疗前记录，并在研究的第13周和第25周重复进行。主要分析旨在比较整个研究期间各组的结局，α水平为0.05（双侧）。
该试验于2020年经大学伦理委员会按照《赫尔辛基宣言》批准（批准号：REC/19 - 20/0504）。该试验一直在招募患者。数据收集将于24个月内完成，从2021年1月1日至2022年12月31日。
鉴于新冠肺炎及其后遗症将在人群中持续存在，本研究的重要发现将为新冠肺炎康复的机制和过程提供有价值的见解。
ClinicalTrials.gov NCT04572360；https://clinicaltrials.gov/ct2/show/NCT04572360。
国际注册报告识别码（IRRID）：PRR1 - 10.2196/25556。
