Efficacy of Dao Yin in patients with 2019 novel coronavirus pneumonia: study protocol for a randomized controlled trial

Background: The epidemic of 2019 novel coronavirus (2019-nCoV) pneumonia has become a focused public health event in world. The authorities have taken prompt medical action in China, which contained strict isolation measures and potential symptomatic supportive care. Dao Yin, a traditional Chinese exercise, combines limb movements and breathing exercises. Previous researches showed that it can activate the immune system and improve the lung function and the mental state of patients. Therefore, there may be a potential effect of Dao Yin on the physical and mental health of patients with 2019-nCoV. The aim of this trail is to verify whether conventional therapy plus Dao Yin could show better effects for 2019-nCoV than conventional therapy alone.Methods/design The study is a multicenter randomized controlled trial with parallel-group design including two intervention groups: a conventional therapy group and a conventional therapy plus Dao Yin group. A total of 186 eligible participants will be randomly assigned to the groups in a 1:1 ratio. The routine treatment of the two groups is performed daily according to guideline, and Dao Yin is performed once a day until the patient is out of the hospital. The primary outcome is the Length of Hospital Stay (LHS). Secondary outcomes include the vital signs, respiratory symptoms, questionnaire of mental health and the quantity of immune cells. The outcomes will be assessed at five points including the baseline, 3th, 6th, 9th day during hospitalization and the discharge day. The significance level is 5%. This study will focus on the value of a conventional therapy plus Dao Yin as the treatment for 2019-nCoV and will explore any potential connection among the outcomes.Discussion This study may evaluate the efficacy of conventional therapy plus Dao Yin for 2019-nCoV, which can contribute to provide a solid evidence of Dao Yin therapy for the nationwide emergence.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029978 Registered on 18 February 2020.