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临床试验/NCT01422993
NCT01422993已完成不适用

A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Number of Screened Patients Who Participate and Complete the Study

研究概览

简要总结

The purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Prior history of colon cancer
  • Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment
  • Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (CIPN) Visual Analog Rating
  • Karnofsky performance status of at least 60%
  • Able to read, write, and understand English

排除标准

  • Patients will be excluded from the study if they live outside of a 30 mile radius of the University of South Florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. The investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.

研究组 & 干预措施

Excercise and Questionnaire

Experimental

12 week exercise program followed by questionnaire.

干预措施: 12 Week Exercise Program (Other)

结局指标

主要结局

Number of Screened Patients Who Participate and Complete the Study

时间窗: 10 Months

To evaluate feasibility, the percentage of patients screened to percentage enrolled in the study and the percentage enrolled to percentage that completes the study will be calculated. Patients who do not complete the study will be contacted to determine why they were unable to complete the study and the reasons will be recorded. How many sessions were attended will also be recorded.

次要结局

  • Number of Participants With Measured Improvement(10 Months)
  • Number of Participants Who Experience Side Effects(10 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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