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八段锦联合耳穴按压对非小细胞肺癌患者术后康复的疗效及安全性:一项随机对照试验方案

Efficacy and safety of combined Baduanjin-auricular acupressure treatment for the postoperative rehabilitation of patients with non-small cell lung cancer: protocol for a randomized controlled trial.

作者信息

Shi Hongmei, Guo Yalun, Dong Haoxu, Pan Mengdie, Li Cong, Hou Xiaoying, Qian Yan, Ye Pei, Ma Shuang, Liu Miao, Zhu Na, Zhang Chunhua

机构信息

Department of Nursing, Zhongnan Hospital of Wuhan University, Wuhan, China.

Department of Geriatrics, Zhongnan Hospital, Wuhan University, Wuhan, China.

出版信息

J Thorac Dis. 2025 Jun 30;17(6):4323-4338. doi: 10.21037/jtd-2025-966. Epub 2025 Jun 26.

Abstract

BACKGROUND

Active participation in postoperative pulmonary rehabilitation training is an indispensable part of the rehabilitation process for patients with lung cancer and is critical to improving the quality of life (QOL). Baduanjin or auricular acupuncture can significantly improve exercise tolerance, fatigue, and QOL in patients with lung cancer. Baduanjin promotes physical function and psychological well-being through gentle movement and breathing control, while auricular acupressure may further alleviate symptoms by modulating neuroendocrine pathways. Their integration could address multidimensional impairments (physical, emotional, and symptom-related) more comprehensively than either intervention alone. Current rehabilitation programs often lack accessible, low-cost adjunct therapies. The combination offers a feasible, patient-centered approach-Baduanjin provides structured exercise, and auricular acupressure requires minimal resources, making it suitable for home-based care. However, there is a paucity of research addressing the joint effects of the combined intervention of Baduanjin and auricular acupressure. Therefore, in this study, we aim to assess the efficacy of the combined intervention of Baduanjin and auricular acupressure as an alternative regimen for postoperative rehabilitation in patients with lung cancer.

METHODS

This four-arm parallel randomized controlled trial will randomize 236 lung cancer surgery patients (1:1:1:1) to: (I) Baduanjin plus auricular acupressure (BG + AAG), (II) Baduanjin group (BG), (III) auricular acupressure group (AAG), or (IV) control group (CG). Primary outcomes [6-minute walk distance (6MWD), cancer-related fatigue scale, and QOL core scale] will be assessed at baseline, 4 and 12 weeks by blinded evaluators. Secondary analysis of 6MWD at 6 months will compare BG + AAG versus CG. Treatment effects will be analyzed using repeated-measures ANOVA with intention-to-treat principle.

DISCUSSION

The four-arm, randomized controlled trial design of the study can enhance both the scientific rigor and reliability of the experiment. Its application can provide clear results and generalizable conclusions for researchers and thus help form a theoretical basis for developing alternative traditional Chinese medicine (TCM) therapy for the postoperative rehabilitation of patients with lung cancer.

TRIAL REGISTRATION

China Clinical Trial Registry (No. ChiCTR2400085060, 30 May 2024).

摘要

背景

积极参与术后肺康复训练是肺癌患者康复过程中不可或缺的一部分,对提高生活质量(QOL)至关重要。八段锦或耳穴针刺可显著改善肺癌患者的运动耐量、疲劳程度及生活质量。八段锦通过轻柔运动和呼吸控制促进身体功能和心理健康,而耳穴按压可能通过调节神经内分泌途径进一步缓解症状。与单独的任何一种干预措施相比,二者结合能更全面地解决多维度损伤(身体、情绪和症状相关)问题。当前的康复项目往往缺乏易于获得的低成本辅助疗法。这种组合提供了一种可行的、以患者为中心的方法——八段锦提供结构化运动,耳穴按压所需资源极少,适合居家护理。然而,针对八段锦与耳穴按压联合干预的联合效果的研究较少。因此,在本研究中,我们旨在评估八段锦与耳穴按压联合干预作为肺癌患者术后康复替代方案的疗效。

方法

这项四臂平行随机对照试验将把236例肺癌手术患者(1:1:1:1)随机分为:(I)八段锦加耳穴按压组(BG + AAG),(II)八段锦组(BG),(III)耳穴按压组(AAG),或(IV)对照组(CG)。主要结局指标[6分钟步行距离(6MWD)、癌症相关疲劳量表和生活质量核心量表]将在基线、第4周和第12周由盲法评估者进行评估。6个月时对6MWD进行的二次分析将比较BG + AAG组与CG组。治疗效果将采用意向性分析原则,通过重复测量方差分析进行分析。

讨论

本研究的四臂随机对照试验设计可提高实验的科学严谨性和可靠性。其应用可为研究人员提供明确的结果和可推广的结论,从而有助于为开发肺癌患者术后康复的替代中医治疗方法形成理论基础。

试验注册

中国临床试验注册中心(编号:ChiCTR2400085060,2024年5月30日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52a3/12268779/44c59aa9326d/jtd-17-06-4323-f1.jpg

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