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临床试验/NCT07635901
NCT07635901已完成不适用

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

Sri Ramachandra Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
282
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seethalakshmi Avudaiappan

Dr. A.Seethalakshmi, Principal Investigator, Professor and Head of the Department, Department of Nursing Foundation

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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