Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial

Abstract Background In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guideline...

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Main Authors: Shuaipan Zhang, Qingguang Zhu, Chao Zhan, Wei Cheng, Xiao Mingfang, Min Fang, Lei Fang
Format: Article
Language:English
Published: BMC 2020-08-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04693-5
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author Shuaipan Zhang
Qingguang Zhu
Chao Zhan
Wei Cheng
Xiao Mingfang
Min Fang
Lei Fang
author_facet Shuaipan Zhang
Qingguang Zhu
Chao Zhan
Wei Cheng
Xiao Mingfang
Min Fang
Lei Fang
author_sort Shuaipan Zhang
collection DOAJ
description Abstract Background In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guidelines for symptomatic supportive care have been used. A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue 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 patients with severe COVID-19. Methods/design This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 128 patients with COVID-19 aged from 20 to 80 years 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 the intervention group will perform acupressure therapy and Liu Zi Jue Qigong exercises in addition to conventional treatments twice a day and will be persistent from admission to discharge. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale. The assessments of the clinical scales will be performed at three points (before treatment, the 7th day during hospitalization, and the discharge day). Adverse events will be noted and recorded for the safety evaluation. Discussion This trial will provide high-quality evidence of the value of TCMR, which consists of acupressure therapy and Liu Zi Jue Qigong exercises, for treating patients with severe COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029994 . Registered on 18 February 2020
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spelling doaj.art-8b24ccd5abf5485d8810dfcda626fe2b2022-12-22T00:16:47ZengBMCTrials1745-62152020-08-0121111110.1186/s13063-020-04693-5Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trialShuaipan Zhang0Qingguang Zhu1Chao Zhan2Wei Cheng3Xiao Mingfang4Min Fang5Lei Fang6Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineYue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineHuangshi Hospital of Traditional Chinese MedicineHuangshi Hospital of Traditional Chinese MedicineHuangshi Hospital of Traditional Chinese MedicineYue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineYue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineAbstract Background In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guidelines for symptomatic supportive care have been used. A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue 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 patients with severe COVID-19. Methods/design This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 128 patients with COVID-19 aged from 20 to 80 years 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 the intervention group will perform acupressure therapy and Liu Zi Jue Qigong exercises in addition to conventional treatments twice a day and will be persistent from admission to discharge. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale. The assessments of the clinical scales will be performed at three points (before treatment, the 7th day during hospitalization, and the discharge day). Adverse events will be noted and recorded for the safety evaluation. Discussion This trial will provide high-quality evidence of the value of TCMR, which consists of acupressure therapy and Liu Zi Jue Qigong exercises, for treating patients with severe COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029994 . Registered on 18 February 2020http://link.springer.com/article/10.1186/s13063-020-04693-5COVID-19Acupressure therapyLiu Zi Jue QigongTraditional Chinese medicine rehabilitationRandomized controlled trialStudy protocol
spellingShingle Shuaipan Zhang
Qingguang Zhu
Chao Zhan
Wei Cheng
Xiao Mingfang
Min Fang
Lei Fang
Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
Trials
COVID-19
Acupressure therapy
Liu Zi Jue Qigong
Traditional Chinese medicine rehabilitation
Randomized controlled trial
Study protocol
title Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
title_full Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
title_fullStr Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
title_full_unstemmed Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
title_short Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
title_sort acupressure therapy and liu zi jue qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia covid 19 a study protocol for a randomized controlled trial
topic COVID-19
Acupressure therapy
Liu Zi Jue Qigong
Traditional Chinese medicine rehabilitation
Randomized controlled trial
Study protocol
url http://link.springer.com/article/10.1186/s13063-020-04693-5
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