Acupressure Therapy and Liu-Zi-Jue Qigong for Pulmonary Function and Quality of Life in Patients with Severe Novel Coronavirus Pneumonia (COVID-19): Study Protocol for a Randomized Controlled Trial

Background : In December, 2019, a pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly, severe patients have a poor prognosis and there are no effective therapies or vaccines for it. Only one rapid advice guideline for symptomatic supportive care has been used for it. A Traditional Chinese medicine Rehabilitation（TCMR） program consisting of acupressure therapy and Liuzijue Qigong can be used as a complementary therapy for COVID-19.Hence, we designed a randomized trial to evaluate the efficacy and advantages of TCMR for treating severe patients with COVID-19. Methods/design : This is a parallel-design, two-arm, analyst-assessor blinded, randomized controlled trial. A total of 120 patients with COVID-19 aged from 20 to 80 will be recruited and assigned randomly into a guideline therapy group and a guideline therapy plus TCMR group at a 1:1 ratio. Patients in both groups will receive guideline therapy. The patients in intervention group will perform acupressure therapy and Liuzijue Qigong exercise on the basis of conventional treatments, twice a day, and have been persistent from admission to discharge. The primary outcomes are measured with Modified Dyspnea Scale (MDS) and Activities of Daily Living (ADL). The secondary outcomes include Patient Health Questionnaire-9 (PHQ-9), Length of Hospital Stay (LHS), Respiratory Symptoms (RS), Liver function test, Renal function test and lung CT. Clinical assessments will at three points (before treatment, 7th day during hospitalization and the discharge day). Adverse events will be noted and recorded for the safety evaluation. Discussion : This trail will provide a high-quality evidence of the value of TCMR, which is consist of acupressure therapy and Liuzijue Qigong exercise for treating severe patients with COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029994 Registered 18 February 2020, http://www.chictr.org.cn/showproj.aspx?proj=49309