A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)
研究概览
简要总结
This phase 2, open-label, dual-center, two-arm randomized controlled trial (RCT) investigates the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance). Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event (chance of having more aggressive disease). A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.
详细描述
PRIMARY OBJECTIVE:
I. Determine the effect of remotely monitored, tailored aerobic training, compared to usual care (print material with physical activity guidance), on cardiopulmonary fitness in men on active surveillance for low-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To determine the effect of aerobic training, compared with usual care, on prostate genomic signatures that predict risk of prostate cancer progression or aggressive disease; and messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue.
II. To determine the effect of aerobic training, compared with usual care, on patient-reported outcomes including active surveillance-specific anxiety, stress, & adherence.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in cardiopulmonary fitness (Arms A, C, and Observational groups only)
时间窗: Up to 16 weeks
Change in cardiopulmonary fitness as indicated by V02max (from CPET) will be compared across each arm. All analyses will employ the intention-to-treat (ITT) approach. Every attempt will be made to complete the week 16 follow-up assessment on all patients.
次要结局
- Effect of aerobic training on general anxiety(At baseline and 16 weeks, 12 months and 24 months after start of intervention)
- Effect of aerobic training on specific prostate cancer anxiety(At baseline and 16 weeks, 12 months and 24 months after start of intervention)
- Adherence to active surveillance(At 24 months)
- Messenger ribonucleic acid (mRNA) expression patterns and prognostic scores in tumor and surrounding stromal (normal) tissue(At baseline and 16 weeks after start of intervention)