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临床试验/NCT03331458
NCT03331458已完成不适用

Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

Duke University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年4月17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
13
试验地点
2
主要终点
Change in distress score

研究概览

简要总结

Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.

The purpose of this study is to

  1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and

  2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:

  3. Examine intervention safety and tolerance by self-report

  4. Examine changes in functional capacity by 6-minute walk test

  5. Examine changes in symptom experience by self-report

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
Male
接受健康志愿者

入选标准

  • Newly diagnosed with prostate cancer
  • will not start treatment for at least 2 weeks
  • able to read and understand English
  • capable of giving informed consent
  • at least 18 years old

排除标准

  • patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)
  • unable to provide informed consent as assessed by the interviewer
  • too sick to participate, as judged by a member of the research team or the exercise physiologist
  • have been treated for another cancer

研究组 & 干预措施

subjects with prostate cancer

Experimental

干预措施: exrecise intervention (Behavioral)

结局指标

主要结局

Change in distress score

时间窗: baseline, 2 weeks post intervention

distress score

Change in rate of perceived exertion

时间窗: baseline, 2 weeks post intervention

physical exertion score

Change in self-efficacy score

时间窗: baseline, 2 weeks post intervention

self-efficacy score

Change in symptom inventory score

时间窗: baseline, 2 weeks post intervention

description of symptoms

Change in balance test

时间窗: baseline, 2 weeks post intervention

Ability to balance

Change in time up to go test

时间窗: baseline, 2 weeks post intervention

Time to get up from chair, walk 30 meters and return to sit in chair

Change in Godin Leisure Time Score

时间窗: baseline, 2 weeks post intervention

physical activity score

Change in metabolic equivalent

时间窗: baseline, 2 weeks post intervention

metabolic activity score

Change in 6 minute walk test

时间窗: baseline, 2 weeks post intervention

Distance walked in 6 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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