A Phase II Randomized Trial of High-Intensity Aerobic Interval Training and Surrogate Markers of Cardiovascular Disease in a Population-based Sample of Testicular Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Peak aerobic capacity (relative VO2peak)
研究概览
简要总结
This study evaluates the impact of a supervised 12-week high-intensity aerobic interval exercise program (versus a self-directed exercise usual care group) on traditional and novel cardiovascular disease risk factors and surrogate markers of cardiovascular- and overall-mortality in a population-based sample of testicular cancer survivors.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed history of testicular cancer
排除标准
- •Not sufficiently ambulatory to complete the first two stages of the aerobic exercise test.
- •Have a psychiatric condition which impairs their ability to perform the required volume and intensity of exercise.
- •Have any uncontrolled cardiovascular condition (i.e. heart disease, hypertension, diabetes, arrhythmia).
- •Report performing any weekly vigorous intensity aerobic exercise in the past month.
研究组 & 干预措施
Exercise Group
Subjects in the exercise group will attend supervised exercise sessions three times a week, for 12 weeks. The exercise intervention will consist of uphill walking or jogging on a treadmill between 50% and 95% of VO2peak for 35 minutes (including a 5-minute warm up and cool down). The participants will complete four, 4-minute, high-intensity intervals at 85-95% of VO2peak. The work period intervals will be interspersed with three, 3-minute periods of active recovery at an intensity below that of their ventilatory threshold.
干预措施: High-intensity aerobic interval exercise (Behavioral)
Usual Care
The usual care group will not receive an intervention, and they will be asked to maintain baseline physical activity levels throughout the observation period.
结局指标
主要结局
Peak aerobic capacity (relative VO2peak)
时间窗: Baseline and within 7 days of completing the 12-week intervention
ml O2/kg/min
次要结局
- Fasting glucose(Baseline and within 7 days of completing the 12-week intervention)
- Modifiable CVD Risk Factor Score(Baseline and within 7 days of completing the 12-week intervention)
- Peak aerobic capacity (absolute VO2peak)(Baseline and within 7 days of completing the 12-week intervention)
- Postexercise 1-minute heart rate recovery(Baseline and within 7 days of completing the 12-week intervention)
- Average carotid intima-media thickness(Baseline and within 7 days of completing the 12-week intervention)
- Carotid distensibility(Baseline and within 7 days of completing the 12-week intervention)
- Velocity time integral(Baseline and within 7 days of completing the 12-week intervention)
- Respiratory sinus arrhythmia(Baseline and within 7 days of completing the 12-week intervention)
- Diastolic blood pressure(Baseline and within 7 days of completing the 12-week intervention)
- Brachial diameter(Baseline and within 7 days of completing the 12-week intervention)
- Maximal carotid intima-media thickness(Baseline and within 7 days of completing the 12-week intervention)
- Carotid diameter(Baseline and within 7 days of completing the 12-week intervention)
- Brachial flow-mediated dilation(Baseline and within 7 days of completing the 12-week intervention)
- Heart rate(Baseline and within 7 days of completing the 12-week intervention)
- Systolic blood pressure(Baseline and within 7 days of completing the 12-week intervention)
- Femoral-toe pulse wave velocity(Baseline and within 7 days of completing the 12-week intervention)
- Low-density lipoprotein(Baseline and within 7 days of completing the 12-week intervention)
- Total cholesterol : high-density lipoprotein ratio(Baseline and within 7 days of completing the 12-week intervention)
- Vascular age(Baseline and within 7 days of completing the 12-week intervention)
- Carotid-femoral pulse wave velocity(Baseline and within 7 days of completing the 12-week intervention)
- Fibrinogen(Baseline and within 7 days of completing the 12-week intervention)
- Total cholesterol(Baseline and within 7 days of completing the 12-week intervention)
- Shear stress during reactive hyperemia(Baseline and within 7 days of completing the 12-week intervention)
- High-density lipoprotein(Baseline and within 7 days of completing the 12-week intervention)
- Triglycerides(Baseline and within 7 days of completing the 12-week intervention)
- Testosterone(Baseline and within 7 days of completing the 12-week intervention)
- Framingham Risk Score(Baseline and within 7 days of completing the 12-week intervention)
- High-sensitivity C-reactive protein(Baseline and within 7 days of completing the 12-week intervention)