Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
2014年4月16日 更新者：Jacob Uth、University of Copenhagen
A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).
The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.
Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.
Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.
It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.
研究概览
研究类型
介入性
注册 (实际的)
57
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Copenhagen、丹麦、2100
- University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone < 1.7) for at least 6 months at the time of inclusion
Exclusion Criteria:
- WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制组
日常护理
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有源比较器：Soccer Training
12 weeks of soccer training.
(2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks.
Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks).
After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone Mineral Density
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Cardiorespiratory fitness (Vo2 peak)
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Patient reported outcomes
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Heart function
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Glucose tolerance
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Oral Glucose Tolerance Test
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Postural Balance
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Assessed standing on a force platform with feet in bilateral, unilateral and tandem position.
Additionally assessed with a modified Flamingo balance test.
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip to waist ratio
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip and waist circumference will be measured and the hip to waist ratio will be calculated
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle Strength
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Blood markers
大体时间：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Markers of inflammation and bone metabolism will be obtained after overnight fasting
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mikael Rørth, Professor、University of Copenhagen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Helge EW, Schmidt JF, Brasso K, Helge JW, Jakobsen MD, Andersen LL, Rorth M, Midtgaard J, Krustrup P. Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations. Eur J Appl Physiol. 2016 Mar;116(3):471-80. doi: 10.1007/s00421-015-3301-y. Epub 2015 Nov 30.
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, Brasso K, Jakobsen MD, Sundstrup E, Andersen LL, Rorth M, Midtgaard J, Krustrup P, Helge EW. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016 Apr;27(4):1507-1518. doi: 10.1007/s00198-015-3399-0. Epub 2015 Nov 16.
- Bruun DM, Krustrup P, Hornstrup T, Uth J, Brasso K, Rorth M, Christensen JF, Midtgaard J. "All boys and men can play football": a qualitative investigation of recreational football in prostate cancer patients. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:113-21. doi: 10.1111/sms.12193.
- Uth J, Hornstrup T, Schmidt JF, Christensen JF, Frandsen C, Christensen KB, Helge EW, Brasso K, Rorth M, Midtgaard J, Krustrup P. Football training improves lean body mass in men with prostate cancer undergoing androgen deprivation therapy. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:105-12. doi: 10.1111/sms.12260.
- Krustrup P, Hansen PR, Nielsen CM, Larsen MN, Randers MB, Manniche V, Hansen L, Dvorak J, Bangsbo J. Structural and functional cardiac adaptations to a 10-week school-based football intervention for 9-10-year-old children. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:4-9. doi: 10.1111/sms.12277.
- Uth J, Schmidt JF, Christensen JF, Hornstrup T, Andersen LJ, Hansen PR, Christensen KB, Andersen LL, Helge EW, Brasso K, Rorth M, Krustrup P, Midtgaard J. Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2012年10月17日
首先提交符合 QC 标准的
2012年10月18日
首次发布 (估计)
2012年10月22日
研究记录更新
最后更新发布 (估计)
2014年4月21日
上次提交的符合 QC 标准的更新
2014年4月16日
最后验证
2014年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.