NCT00868868Unknown不适用
Pedometer and Exercise Study: A Randomized Trial Evaluating the Use of a Pedometer and Brief Exercise Coaching in Prostate Cancer Patients Treated With Androgen Deprivation Therapy.
Groupe de recherche en Urologie de la Mauricie1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.
详细描述
To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Histologically proven prostate cancer
- •Treatment plan is to administer long term ADT (androgen deprivation therapy).
- •Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
- •Written informed consent to participate in the trial.
排除标准
- •Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
- •Severe cardiac disease (New York Heart Association class III or greater)
- •Severe lung disease
- •Uncontrollable pain
- •Unstable bone lesion
- •Any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg Parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
- •Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
- •Any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). The patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
- •Unwillingness or incapacity to consent to trial participation.
研究者
研究点 (1)
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