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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
结局指标
主要结局
Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
时间窗: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
次要结局
- Physical function(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Patient reported outcomes(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Bone Mineral Density(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Cardiorespiratory fitness (Vo2 peak)(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Hip to waist ratio(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Muscle Strength(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Blood markers(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Heart function(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Glucose tolerance(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
- Postural Balance(Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
研究者
Jacob Uth
Project manager, Ph.d student, Master of Health Science
University of Copenhagen