Miyata Chieko, Furuta Hirokazu, Mizuno Kohei, Nagayama Yoshiyuki, Hosaka Yosuke
Clinical Research Center, NHO Tokyo medical center, 2-5-1, Higashigaoka, Meguro-ku, Tokyo, 152-8902, Japan.
Department of Rehabilitation medicine, NHO Tokyo medical center, 2-5-1, Higashigaoka, Meguro-ku, Tokyo, 152-8902, Japan.
BMC Sports Sci Med Rehabil. 2025 Jul 2;17(1):170. doi: 10.1186/s13102-025-01223-1.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that affects the sensory, motor, and autonomic nerves. CIPN often leads to extremity dysfunction and reduced quality of life (QOL). Pharmacological therapies, such as duloxetine, have demonstrated efficacy in managing CIPN, and rehabilitation has emerged as a promising non-pharmacological treatment; however, the optimal exercise protocol remains unclear. Recent studies have suggested that home-based rehabilitation is feasible and safe for patients with cancer. This study aimed to evaluate the feasibility and safety of a 12-week hybrid intervention, combining outpatient supervision with home-based self-exercise in patients with CIPN.
This prospective observational study included 25 patients (17 women; mean age, 65.0 ± 9.3 years) with CIPN, 88% of whom had advanced or recurrent cancer. The intervention encompassed supervised outpatient rehabilitation sessions led by physical and occupational therapists and self-exercises at home. Primary outcomes included rehabilitation program completion and training adherence rates. Secondary outcomes included sensory nerve function, physical function, manual dexterity, QOL, and chemotherapy adherence. Descriptive statistics were used to summarize adherence rates. For the analysis of continuous variables, missing data were assumed to be missing at random and were handled using multiple imputation (MI), followed by generalized linear models (GLM). A total of 100 imputations were generated to ensure the stability and reliability of the estimates.
The study completion rate was 76.0%, with an 88% adherence rate for both supervised and self-exercise components. The MI-based analysis showed significant improvements in physical function from T1 to T3, as measured by the Cancer Functional Assessment Set (β = 6.65, 95% CI: 0.2-13.0, p < 0.05), whereas sensory nerve function, manual dexterity, and QOL remained unchanged. Chemotherapy adherence remained favorable throughout the program.
The present study demonstrated the feasibility and safety of a combined outpatient-supervised and home-based exercise intervention for patients with CIPN. These findings highlight the practicability of incorporating an exercise regimen into a CIPN management protocol to support ongoing chemotherapy.
This study was retrospectively registered in the University Hospital Medical Information Network Clinical Trials Registry on 19/11/2024 (UMIN-CTR ID: UMIN 000056201).
化疗引起的周围神经病变（CIPN）是化疗常见的不良反应，会影响感觉神经、运动神经和自主神经。CIPN常导致肢体功能障碍并降低生活质量（QOL）。诸如度洛西汀等药物治疗已证明在管理CIPN方面有效，康复已成为一种有前景的非药物治疗方法；然而，最佳运动方案仍不明确。最近的研究表明，居家康复对癌症患者是可行且安全的。本研究旨在评估一项为期12周的混合干预措施的可行性和安全性，该干预措施将门诊监督与CIPN患者的居家自我锻炼相结合。
这项前瞻性观察性研究纳入了25例CIPN患者（17例女性；平均年龄65.0±9.3岁），其中88%患有晚期或复发性癌症。干预措施包括由物理治疗师和职业治疗师主导的门诊监督康复课程以及居家自我锻炼。主要结局包括康复计划完成率和训练依从率。次要结局包括感觉神经功能、身体功能、手部灵巧度、生活质量和化疗依从性。采用描述性统计来总结依从率。对于连续变量的分析，假设缺失数据是随机缺失的，并使用多重插补（MI）进行处理，随后采用广义线性模型（GLM）。总共生成了100次插补以确保估计值的稳定性和可靠性。
研究完成率为76.0%，监督锻炼和自我锻炼部分的依从率均为88%。基于MI的分析显示，从T1到T3，身体功能有显著改善，通过癌症功能评估集测量（β = 6.65，95%CI：0.2 - 13.0，p < 0.05），而感觉神经功能、手部灵巧度和生活质量保持不变。在整个项目中，化疗依从性保持良好。
本研究证明了针对CIPN患者的门诊监督与居家锻炼相结合的干预措施的可行性和安全性。这些发现突出了将运动方案纳入CIPN管理方案以支持正在进行的化疗的实用性。
本研究于2024年11月19日在大学医院医学信息网络临床试验注册中心进行回顾性注册（UMIN - CTR ID：UMIN 000056201）。
