简易坐式八段锦身心锻炼：针对患有疲劳-睡眠障碍症状群的晚期癌症患者的随机对照试验方案
Simple Sitting Baduanjin mind-body exercise: randomized controlled trial protocol for advanced cancer patients with the fatigue-sleep disturbance symptom cluster.
作者信息
Zou Huina, Lin Xiaoyan, Duan Tingjin, Zheng Jianwei, Xiao Huimin
机构信息
School of Nursing, Fujian Medical University, Fuzhou, China.
Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China.
出版信息
BMC Complement Med Ther. 2024 Oct 2;24(1):348. doi: 10.1186/s12906-024-04652-6.
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.
背景
晚期癌症患者常伴有疲劳-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有前景的身心锻炼方式。然而，针对晚期癌症患者量身定制八段锦的研究较少。本拟开展的研究将创建一个优化的八段锦锻炼方案以适应晚期癌症患者，并评估简易坐式八段锦身心锻炼对晚期癌症患者疲劳-睡眠障碍症状群的影响。
方法
本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4周的随访。将从中国两家三级综合医院招募108名出现疲劳-睡眠障碍症状群的晚期癌症患者。参与者将被随机分为实验组（n = 54）或对照组（n = 54）。实验组将接受为期12周的简易坐式八段锦干预加常规护理，对照组仅接受常规护理。将在干预前、干预第4周、第8周和第12周以及干预后4周测量包括疲劳-睡眠障碍症状群、疲劳、睡眠障碍和生活质量在内的结局指标。将采用意向性分析原则和广义估计方程进行数据分析。
讨论
本研究可能会产生一种新的八段锦锻炼处方，该处方用户友好、易于执行、更具针对性且适应性强。如果被证明有效，这种方法可能会被纳入常规癌症护理，以管理晚期癌症患者的疲劳-睡眠障碍症状群并改善生活质量。
试验注册
中国临床试验注册中心，ChiCTR-2,300,072,331。于2023年6月9日注册。
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