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Abstract：
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.
CONCLUSIONS: 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.
BACKGROUND: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2400080763).
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.
CONCLUSIONS: 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.
BACKGROUND: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2400080763).
摘要：
背景：失眠在大学生中很常见，但它对健康和福祉的影响往往被忽视。通过有针对性的干预措施提高睡眠质量可以改善整体健康状况，并降低随之而来的合并症和心理健康问题的风险。气功练习已被证明可以显着改善睡眠质量并缓解失眠。三圈立柱站立（TCPS）可以帮助整合身体，呼吸,和头脑，气功促进整体福祉的基本原则。在这个临床试验中,我们的目标是(1)评估可行性，安全,以及给予TCPS改善失眠大学生睡眠质量和生活质量的治疗效果；（2）探索TCPS介导的失眠心理调节的神经生理机制；（3）研究TCPS介导的失眠的身体和呼吸病理生理；（4）评估TCPS在睡眠质量和生活质量方面的长期疗效。
方法：这将是一个前瞻性的，平行,四臂,本研究采用双盲随机对照试验研究TCPS治疗大学生失眠的效果及机制。100名符合失眠诊断标准的大学生将被随机分配接受14周的标准化TCPS培训（两周的集中培训，然后进行12周的监督培训）或假对照站立后培训。疗效结果包括睡眠质量，生活质量,神经生理学评估，足底压力,生物力学平衡，物理测量将在基线收集，八周（监督训练的中间点），和14周（监督训练结束）。睡眠质量和生活质量也将在4周和8周的随访期间进行评估。
结论：该试验将是失眠治疗新方法发展的一个重要里程碑，应该容易为失眠大学生实施。神经和病理生理学评估将为TCPS的潜在机制提供新的见解。
背景：该试验已在中国临床试验注册中心注册（注册号：ChiCTR2400080763）。
方法：这将是一个前瞻性的，平行,四臂,本研究采用双盲随机对照试验研究TCPS治疗大学生失眠的效果及机制。100名符合失眠诊断标准的大学生将被随机分配接受14周的标准化TCPS培训（两周的集中培训，然后进行12周的监督培训）或假对照站立后培训。疗效结果包括睡眠质量，生活质量,神经生理学评估，足底压力,生物力学平衡，物理测量将在基线收集，八周（监督训练的中间点），和14周（监督训练结束）。睡眠质量和生活质量也将在4周和8周的随访期间进行评估。
结论：该试验将是失眠治疗新方法发展的一个重要里程碑，应该容易为失眠大学生实施。神经和病理生理学评估将为TCPS的潜在机制提供新的见解。
背景：该试验已在中国临床试验注册中心注册（注册号：ChiCTR2400080763）。
