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Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy

2026年6月3日 更新者：Seethalakshmi Avudaiappan、Sri Ramachandra Institute of Higher Education and Research

Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients

Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life. This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India. Phase I used a descriptive survey design to determine the prevalence of CIPN. Phase II employed a randomized controlled experimental design to evaluate the effectiveness of a structured exercise program in reducing CIPN symptoms among patients with mild to moderate CIPN. Eligible participants were randomly assigned to intervention and control groups. The intervention group received education and supervised exercises involving lower and upper extremity movements, while the control group received routine care. Outcomes were assessed using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale before and after a 21-day intervention period.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This quantitative study was conducted in two phases. Phase I assessed the prevalence of chemotherapy-induced peripheral neuropathy among oncology patients receiving chemotherapy. A total of 282 participants were enrolled.

Based on the prevalence findings, Phase II was conducted to determine the effectiveness of a structured exercise program. One hundred and twenty patients with mild or moderate CIPN were randomly allocated into intervention (n=60) and control (n=60) groups using a lottery method. The intervention consisted of education regarding CIPN and a structured exercise program including toe flexion and extension, ankle circles, toe spreading, heel raises, finger extension stretches, pinch grips, and finger circles. Exercises were performed 10-15 repetitions per extremity, 2-3 times daily, for 21 days.

Participants in the control group received routine oncology care. CIPN severity was measured before and after the intervention using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale. Statistical analyses included descriptive statistics, paired t-tests, independent t-tests, and chi-square tests.

研究类型

介入性

注册 (实际的)

282

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 印度
    • Tamil Nadu
      • Chennai、Tamil Nadu、印度、600116
        • Sri Ramachandra Institute of Higher Education and Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age greater than 18 years
  • Receiving chemotherapy
  • Diagnosed with mild or moderate chemotherapy-induced peripheral neuropathy
  • Willing to participate and provide informed consent

Exclusion Criteria:

  • Pre-existing peripheral neuropathy unrelated to chemotherapy (e.g., diabetic neuropathy).
  • Uncontrolled diabetes mellitus.
  • Significant cardiovascular disease.
  • Severe musculoskeletal disorders.
  • Contraindications to exercise, including recent surgery, bone metastases, or severe anemia.
  • Severe mobility limitations.
  • Severe mental health conditions affecting participation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental Arm: Structured Exercise Program
Participants received structured education regarding chemotherapy-induced peripheral neuropathy and performed a supervised exercise program involving lower and upper extremity exercises for 21 days in addition to routine care.
行为的：Structured exercise program for CIPN
Patients in the intervention group receive structured education about CIPN, which included its definition, risk factors, signs and symptoms, and management through exercises. The exercises were demonstrated by the researcher and involved leg toe flexion and extension, ankle circles, toe spreading, heel raises, as well as hand exercises such as finger extension stretches, pinch grips, and finger circles. Participants were asked to return demonstrate the exercises, continue practicing them under supervision for one to two days during hospitalization for chemotherapy and after discharge for a period of 21 days when they came for their subsequent cycle of chemotherapy. This was then reinforced using a pamphlet which was provided to the patients, and patients were encouraged to maintain a daily practice
无干预：Control Arm: Routine Care
Participants received standard oncology care including consultation and medication management according to institutional protocols.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Severity of Chemotherapy-Induced Peripheral Neuropathy
大体时间：Baseline and Day 21
Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
Baseline and Day 21

次要结果测量

结果测量
措施说明
大体时间
Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy.
大体时间：At baseline assessment.
Prescence of CIPN and its severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
At baseline assessment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sri Ramachandra Institute of Higher Education and Research

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月1日

初级完成 (实际的)

2024年12月1日

研究完成 (实际的)

2024年12月1日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 05/185

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared. De-identified data may be available from the corresponding investigator upon reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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