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临床试验/NCT02631681
NCT02631681已完成不适用

Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年8月最近更新:
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
200
试验地点
2
主要终点
Change in 30second Chair-Stand test (30s-CST)

研究概览

简要总结

Exercise intervention for men with prostate cancer on androgen deprivation therapy.

详细描述

The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

  • Functional capacity
  • Quality of life
  • Body composition
  • Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Patients with a prostate cancer diagnosis on androgen deprivation therapy

排除标准

  • Opioid demanding treatment for skeletal pain
  • Eastern Cooperative Oncology Group performance status > 2
  • Inability to perform floor and machine exercises independently

研究组 & 干预措施

Men with prostate cancer on androgen deprivation therapy

Experimental

Group based supervised combined aerobic and resistance training for 12 weeks.

干预措施: Group based exercise (Behavioral)

结局指标

主要结局

Change in 30second Chair-Stand test (30s-CST)

时间窗: Baseline, 12 and 24 weeks

Test of functional capacity, measured as change

Change in Graded Cycling Test with Talk Test (GCT-TT)

时间窗: Baseline, 12 and 24 weeks

Test of functional capacity, measured as change

次要结局

  • change in QoL(Baseline, 12 and 24 weeks)
  • change in Body composition(Baseline, 12 and 24 weeks)
  • change in Bloodpressure(Baseline, 12 and 24 weeks)
  • Safety of exercise assessed by serious adverse events according to the FDA(Study period baseline - 24 weeks)
  • Compliance assessed by attendance and continued exercise (yes/no)(Baseline, 12 and 24 weeks)

研究者

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

Peter Busch Østergren

M.D.

Herlev Hospital

研究点 (2)

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