NCT00834392已完成不适用
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- bone health
研究概览
简要总结
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men aged 50 years or older
- •diagnosed with adenocarcinoma prostate cancer
- •will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
- •Patients will also consent to participating in the study.
排除标准
- •severe cardiac disease (New York Heart Association class III or greater)
- •severe osteoporosis
- •uncontrolled hypertension (blood pressure > 160/95mm Hg)
- •orthostatic blood pressure drop > 20mm Hg
- •moderate to severe aortic stenosis
- •acute illness or fever
- •uncontrolled atrial or ventricular dysrhythmias
- •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, pathological lower limb fractures within 6 months, lower limb amputation).
结局指标
主要结局
bone health
时间窗: baseline, 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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