Simple Sitting Baduanjin mind-body exercise: randomized controlled trial protocol for advanced cancer patients with the fatigue-sleep disturbance symptom cluster.

IF 3.3 2区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

BMC Complementary Medicine and Therapies Pub Date : 2024-10-02 DOI:10.1186/s12906-024-04652-6

Huina Zou, Xiaoyan Lin, Tingjin Duan, Jianwei Zheng, Huimin Xiao

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Abstract

Background: Advanced cancer patients commonly suffer from a fatigue-sleep disturbance symptom cluster. Baduanjin is considered a promising mind-body exercise for relieving the fatigue-sleep disturbance symptom cluster. However, few studies have investigated a tailored Baduanjin for advanced cancer patients. The proposed study will create an optimized Baduanjin exercise program to adapt to advanced cancer patients and evaluate the effect of a Simple Sitting Baduanjin (SSBDJ) mind-body exercise on the fatigue-sleep disturbance symptom cluster among advanced cancer patients.

Methods: The study will be a prospective, assessor-blinded, two-arm, randomized controlled trial, involving a 12-week intervention and 4-week follow-up. A total of 108 advanced cancer patients experiencing the fatigue-sleep disturbance symptom cluster will be recruited from two tertiary general hospitals in China. Participants will be randomized to an experimental group (n = 54) or a control group (n = 54). The experimental group will receive a 12-week SSBDJ intervention plus the usual care, and the control group will receive only the usual care. Outcomes including fatigue-sleep disturbance symptom cluster, fatigue, sleep disturbance, and quality of life will be measured before the intervention, at the 4th, 8th, and 12th weeks of the intervention, and 4 weeks after the intervention. The intention-to-treat principle and a generalized estimating equation will be used to analyze data.

Discussion: This study may produce a new Baduanjin exercise prescription that is user-friendly, simple to execute, more targeted, and adaptable. If proven effective, this approach may be integrated into routine cancer care to manage the fatigue-sleep disturbance symptom cluster and improve QOL in advanced cancer patients.

Trial registration: Chinese Clinical Trial Registry, ChiCTR-2,300,072,331. Registered on 9 June 2023.

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简易八段锦坐姿身心锻炼：针对晚期癌症患者疲劳-睡眠障碍症状群的随机对照试验方案。

背景：晚期癌症患者通常会出现疲劳-睡眠障碍症状群。八段锦被认为是缓解疲劳-睡眠障碍症状群的一种很有前景的身心锻炼方法。然而，很少有研究针对晚期癌症患者量身定制八段锦。本研究将为晚期癌症患者量身定制优化的八段锦锻炼计划，并评估简单坐姿八段锦（SSBDJ）身心锻炼对晚期癌症患者疲劳-睡眠障碍症状群的影响：该研究将是一项前瞻性、评估者盲法、双臂随机对照试验，包括为期 12 周的干预和为期 4 周的随访。研究将从中国两家三级综合医院共招募108名出现疲劳-睡眠障碍症状群的晚期癌症患者。参与者将被随机分配到实验组（54 人）或对照组（54 人）。实验组将接受为期 12 周的 SSBDJ 干预和常规护理，对照组仅接受常规护理。结果包括疲劳-睡眠障碍症状群、疲劳、睡眠障碍和生活质量，将在干预前、干预的第 4 周、第 8 周和第 12 周以及干预后 4 周进行测量。数据分析将采用意向治疗原则和广义估计方程：本研究可能会产生一种新的八段锦运动处方，这种处方使用方便、执行简单、针对性更强、适应性更强。讨论：本研究可能会产生一种新的八段锦运动处方，该处方操作方便、简单易行、针对性更强、适应性更广，如果被证明有效，这种方法可能会被纳入常规癌症护理中，以管理疲劳-睡眠障碍症状群，改善晚期癌症患者的 QOL：中国临床试验注册中心，ChiCTR-2,300,072,331。注册日期：2023年6月9日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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