Would cardiorespiratory exercise and Chinese herbal medicine facilitate rehabilitation from pulmonary fibrosis among post-discharge patients with COVID-19? Clinical efficacy and mechanisms
The proposed study will be a triple-blinded randomized controlled trial (RCT) comprising four groups, an exercise plus Chinese herbal medicines group, an exercise group in isolation, a Chinese herbal medicines group and a waiting list control group. About 172 post-discharge patients recovering from COVID-19 diagnosed with pulmonary fibrosis in Hong Kong will be recruited via our International Rehabilitation Network Center for patients with COVID-19 (43 patients/group).
The exercise intervention element will consist of: i) 36 home-based tele-exercise sessions (3 sessions/week, 40-60 min/session) where remote monitoring of vital signs will be required. Each session will involve aerobic training, resistance training, and inspiratory muscle training; ii) 12 counselling sessions (once/week) on motivation, individualized action plan, self-management and habit formation of exercise on a daily basis; iii) access to a call center. For the Chinese herbal medicine intervention element, the Modified BaiHe Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. The proposed rehabilitation period will last for 12 weeks with a 12-week follow-up.
Primary health outcomes examined will include the clinical symptoms of pulmonary fibrosis (dyspnea, fatigue, lung function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry). Blood biochemistry will be further analyzed using unique metabolomics techniques to identify potential synergies related to the immune function response to the interventions. We will investigate glucose metabolism and its association with the degree of infection/prognosis. We will also profile the gut microbial metabolome to establish associations between (virus-induced) dysbiosis and the outcomes of COVID-19 infection. Pulmonary function tests will be completed using clinical spirometry, as outlined by the American Thoracic Society. Blood gas levels, immune function, and coagulation levels of the patients will be measured in venous blood samples. In addition, socio-demographic information, medical history (including COVID-19), and health-related behaviors (including physical activity, eating habits, smoking, drinking, and sleeping) will be collected using questionnaires and adjusted for in data analysis. All above-mentioned measurements (excluded socio-demographic characteristics) will be repeatedly measured three times at pre- and post-intervention and 12 weeks after the intervention to identify potential improvement, regression or maintenance of the treatment intervention.
A focus on rehabilitation, using a combination of exercise and Chinese medicine, and exploring the role of gut microbiome in a mechanistic manner would make the proposed study the first of this kind for this type of experimental intervention. Given that COVID-19 would persist in human populations, important findings from this study would provide valuable insights into the mechanisms and processes that are active during rehabilitation.
Interested applicants should be educated in health- and/or exercise-related fields and those with research experiences in exercise and other lifestyle-related interventions, those with excellent written and spoken English skills, and those with self-motivation will be highly desirable.
Associate Vice-President (Chinese Medicine Development)
Tsang Shiu Tim Endowed Chair of Chinese Medicine Clinical Studies