Xie Chaoqun, Xie Fangfang, Ma Jianwen, Yue Hongyu, You Yanli, Yao Fei
School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Department of Acupuncture-Moxibustion Tuina and Rehabilitation Center, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.
JMIR Res Protoc. 2023 Dec 12;12:e53501. doi: 10.2196/53501.
Chronic insomnia (CI) is a mind-body disease that is commonly defined as a state of having disturbed daytime activities due to poor nighttime sleep quality. Baduanjin qigong (BDJQG) is widely used for CI in China. However, there is little scientific evidence to evaluate its effects on the hyperarousal state, which is closely associated with improved sleep quality.
The objective of the trial is to assess the therapeutic effects of BDJQG on sleep quality in patients with CI.
A randomized controlled trial will be conducted on 86 patients, who will be divided into a BDJQG group and a cognitive behavioral therapy for insomnia group at a ratio of 1:1. Interventions in both groups will be given to the participants 7 times a week for 8 weeks, and the participants will be followed up for 4 weeks. The primary outcome is the change in the Pittsburgh Sleep Quality Index from baseline to week 8. The secondary outcomes are the changes in the Hyperarousal Scale, Insomnia Severity Index, Fatigue Scale-14, wrist actigraphy, salivary cortisol level, and functional magnetic resonance imaging from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle.
This study was funded from January 2023. As of the submission of the manuscript, there were 86 participants. Data collection began in April 2023 and will end in January 2024. Data analysis is expected to begin in January 2024, with the publication of results expected in February 2024.
This study will present data concerning the clinical effects of BDJQG on CI. The results will help to demonstrate whether BDJQG is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. This study will provide much-needed knowledge for complementary and alternative therapy for patients with CI.
China Clinical Registration Agency ChiCTR2300069241; https://chictr.org.cn/bin/project/ChiCTR2300069241.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53501.
慢性失眠（CI）是一种身心疾病，通常被定义为由于夜间睡眠质量差而导致白天活动受干扰的状态。八段锦气功（BDJQG）在中国被广泛用于治疗慢性失眠。然而，几乎没有科学证据来评估其对与改善睡眠质量密切相关的高觉醒状态的影响。
本试验的目的是评估八段锦气功对慢性失眠患者睡眠质量的治疗效果。
将对86名患者进行一项随机对照试验，这些患者将按1:1的比例分为八段锦气功组和失眠认知行为治疗组。两组干预措施均为每周对参与者进行7次，共8周，并对参与者进行4周的随访。主要结局是匹兹堡睡眠质量指数从基线到第8周的变化。次要结局是高觉醒量表、失眠严重程度指数、疲劳量表-14、腕部活动记录仪、唾液皮质醇水平以及从基线到第8周的功能磁共振成像的变化。所有主要分析将基于意向性分析原则进行。
本研究于2023年1月获得资助。截至稿件提交时，有86名参与者。数据收集于2023年4月开始，将于2024年1月结束。数据分析预计于2024年1月开始，结果预计于2024年2月发表。
本研究将呈现有关八段锦气功对慢性失眠临床疗效的数据。结果将有助于证明八段锦气功是否是一种有效的疗法，可通过降低高觉醒水平这一可能的潜在机制来改善睡眠质量。本研究将为慢性失眠患者的补充和替代疗法提供急需的知识。
中国临床试验注册中心ChiCTR2300069241；https://chictr.org.cn/bin/project/ChiCTR2300069241。
国际注册报告识别码（IRRID）：PRR1-10.2196/53501。
