Efficacy and underlying mechanisms of three-circle post standing qigong on insomnia in college students: a four-arm, double-blind, randomized controlled trial protocol

Author: Ming-Min Xu#1, Nan Li#1, Tian-Nuo Hu#1, Zheng-Kun Zhou2, Yue Chen3, Xue Huang4, Yulong Wei5, Yu Guo6,7
Affiliation: <sup>1</sup> School of Traditional Chinese Medicine, Jinan University, Guangzhou, China. <sup>2</sup> International Liaison Department, World Federation of Chinese Medicine Societies, Beijing, China. <sup>3</sup> School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China. <sup>4</sup> Yangfang Outpatient Department, Northern District of People&#x27;s Liberation Army General Hospital, Beijing, China. huang921221xue@163.com. <sup>5</sup> School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China. wylbucm@163.com. <sup>6</sup> School of Traditional Chinese Medicine, Jinan University, Guangzhou, China. guoy046@jnu.edu.cn. <sup>7</sup> Guangzhou Key Laboratory of Formula-Pattern of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Jinan University, Guangzhou, China. guoy046@jnu.edu.cn.
Conference/Journal: BMC Complement Med Ther
Date published: 2024 Jun 18
Other: Volume ID: 24 , Issue ID: 1 , Pages: 239 , Special Notes: doi: 10.1186/s12906-024-04544-9. , Word Count: 334


Background:
Insomnia is common in college students, but its impact on health and wellbeing is often neglected. Enhancing sleep quality through targeted interventions could improve overall health and reduce the risk of consequent co-morbidities and mental health problems. Qigong exercises have been shown to significantly improve sleep quality and relieve insomnia. Three-circle Post Standing (TCPS) can help integrate body, breath, and mind, a fundamental principle of Qigong that promotes holistic wellbeing. In this clinical trial, we aim to (1) evaluate the feasibility, safety, and therapeutic efficacy of administering TCPS to improve sleep quality and quality of life in college students with insomnia; (2) explore the neurophysiological mechanisms underlying the mind adjustments mediated by TCPS in insomnia; (3) investigate body and breath pathophysiology mediated by TCPS in insomnia; and (4) assess the long-term efficacy of TCPS in terms of sleep quality and quality of life.

Methods:
This will be a prospective, parallel, four-arm, double-blind randomized controlled trial to investigate the effects and underlying mechanisms of TCPS on college students with insomnia. One hundred college students meeting diagnostic criteria for insomnia will be randomly assigned to receive either 14 weeks of standardized TCPS training (two weeks of centralized training followed by 12 weeks of supervised training) or sham-control Post Standing training. Efficacy outcomes including sleep quality, quality of life, neurophysiological assessments, plantar pressure, biomechanical balance, and physical measures will be collected at baseline, eight weeks (mid-point of supervised training), and 14 weeks (end of supervised training). Sleep quality and quality of life will also be evaluated during the four- and eight-week follow-up.

Discussion:
This trial will be an important milestone in the development of new therapeutic approaches for insomnia and should be easily implementable by college students with insomnia. The neuro- and pathophysiological assessments will provide new insights into the mechanisms underlying TCPS.

Clinical trial registration:
This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2400080763).

Keywords: College students; Insomnia; Randomized clinical trial; Therapeutic clinical effects and underlying mechanisms; Three-circle Post Standing Qigong.

PMID: 38890651 DOI: 10.1186/s12906-024-04544-9