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


Author: Huina Zou1, Xiaoyan Lin2, Tingjin Duan3, Jianwei Zheng2, Huimin Xiao4,5

Affiliation: <sup>1</sup> School of Nursing, Fujian Medical University, Fuzhou, China.

<sup>2</sup> Department of Oncology, Fujian Medical University Union Hospital, Fuzhou, China.

<sup>3</sup> Sports Department, Fujian University of Traditional Chinese Medicine, Fuzhou, China.

<sup>4</sup> School of Nursing, Fujian Medical University, Fuzhou, China. huimin_xiao@126.com.

<sup>5</sup> Research Center for Nursing Humanity, Fujian Medical University, Fuzhou, China. huimin_xiao@126.com.
Conference/Journal: BMC Complement Med Ther
Date published: 2024 Oct 2
Other:
 Volume ID: 24   ,  Issue ID: 1   ,  Pages: 348   ,  Special Notes: doi: 10.1186/s12906-024-04652-6.   ,  Word Count: 277  
    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.



Keywords: Advanced cancer; Baduanjin; Fatigue; Quality of life; Sleep; Symptom cluster.



PMID: 39358730 PMCID: PMC11448021 DOI: 10.1186/s12906-024-04652-6