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临床试验/NCT03397030
NCT03397030已完成不适用

Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer

The University of Texas Health Science Center at San Antonio4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
4
主要终点
Change in concentration of circulating Prognostic Biomarkers

研究概览

简要总结

The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.

详细描述

Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.

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

盲法说明

No masking was used in this study.

入排标准

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

入选标准

  • Men aged 40 or older
  • Ambulating male
  • Diagnosed with low grade prostate cancer
  • Subjects willing and able to provide consent to participating in the study Exclusion Criteria
  • prostatectomy
  • severe cardiac disease (New York Heart Association class III or greater)
  • severe osteoporosis
  • uncontrolled hypertension (blood pressure > 160/95mm Hg)
  • uncontrolled sinus tachycardia (> 120 beats per minute)
  • uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness,
  • severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).

排除标准

  • 未提供

结局指标

主要结局

Change in concentration of circulating Prognostic Biomarkers

时间窗: Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.

Analyze concentrations of Prostate-specific antigen (PSA), Prostate-specific membrane antigen (PSMA), Early prostate cancer antigen (EPCA), Urokinase plasminogen activator (uPA), and Urokinase plasminogen activator receptor (uPAR) in serum collected at each visit with research staff.

次要结局

  • Fatigue Biomarker Index(Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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