Enhancing Active Surveillance With Exercise (EASE): A Pilot Randomized Trial in Localized Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall attendance
研究概览
简要总结
This randomized pilot clinical trial compares vigorous or moderate exercise in enhancing active surveillance in patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Active surveillance involves watching the patient's condition but not giving any treatment unless test results show that the patient's condition is getting worse. Exercise may improve fitness, quality of life, brain health, and blood biomarkers in patients with prostate cancer on active surveillance. It is not yet known whether vigorous or moderate exercise works better in enhancing active surveillance in patients with localized prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of performing vigorous intensity aerobic exercise using progressive, high-intensity interval training (HIIT) with standard stationary cycling and 'cybercycling' compared to moderate intensity aerobic exercise with standard stationary cycling in prostate cancer (PCa) survivors on active surveillance (AS).
II. To explore the potential effects of vigorous intensity aerobic exercise (HIIT) using standard cycling and 'cybercycling' compared to moderate intensity standard cycling on changes in quality of life (QoL), cognition, fitness circulating inflammatory biomarkers and PCa-specific markers of progression (prostate specific antigen [PSA], time to AT) in PCa survivors in active surveillance (AS); and, to explore if these effects may be mediated by changes in body fat.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
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
- •Adult men of all races and body size with histologically confirmed localized PCa on AS
- •Approved to be contacted by the treating urologist
- •Meet screening criteria
- •Complete American Heart Association (AHA)/American College of Sports Medicine (ACSM) exercise questionnaire
- •Undergo cardiopulmonary exercise (CPX) testing utilizing a cycle ergometer. If the CPX test is terminated secondary to hemodynamic instability, arrhythmias or ischemic signs, the patient will be ineligible.
排除标准
- •Patients unable to provide informed consent
- •Patients participating in a structured exercise program in the past 6 months
- •Patients not available for follow-up tests
- •Patients with pre-existing medical conditions that would be a barrier to exercise
研究组 & 干预措施
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: moderate exercise intervention (Behavioral)
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: questionnaire administration (Other)
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: Exercise Logs (Behavioral)
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: Adherence (Behavioral)
Arm I (moderate intensity exercise)
Patients perform moderate intensity exercise on a stationary bike for 20-50 minutes, three days a week for 16 weeks.
干预措施: Exercise and body composition test (Behavioral)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: vigorous exercise intervention - standard (Behavioral)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: questionnaire administration (Other)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: Exercise Logs (Behavioral)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: Adherence (Behavioral)
Arm II (HIIT exercise on a standard stationary bike)
Patients perform HIIT exercise on a standard stationary bike, three days a week for 16 weeks.
干预措施: Exercise and body composition test (Behavioral)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: questionnaire administration (Other)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: vigorous exercise intervention - cybercycling (Behavioral)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: Exercise Logs (Behavioral)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: Adherence (Behavioral)
Arm III (HIIT exercise on a cybercycle)
Patients perform HIIT exercise on a cybercycle using racing or other games, three days a week for 16 weeks.
干预措施: Exercise and body composition test (Behavioral)
结局指标
主要结局
Overall attendance
时间窗: Up to 16 weeks
Average number of people who attend each session
Overall adherence to the exercise protocol as measured by average time in HIIT intervals for HIIT groups
时间窗: Up to 16 weeks
Average number of minutes in HIIT intervals which are defined as exercising at 80-90% WR_peak
Adherence to the exercise protocol as measured by average time in the target heart rate (THR) zone
时间窗: Up to 16 weeks
the target heart rate zone will be determined using the Karvonen formula: THR=((HRmax - HRrest) × % Intensity) + HRrest. Total time in this zone will be recorded every 5 minutes and the overall average will be recorded
次要结局
- Average change in the Exercise Motivations Inventory (EMI-2)(Baseline up to 16 weeks)
- Change in body mass index as a measure of body composition(Baseline up to 16 weeks)
- Change in quality of life, measured using the Functional Assessment of Cancer Therapy (FACT)(Baseline up to 16 weeks)
- Average change in fitness(Baseline up to 16 weeks)
- Change in cognition(Baseline up to 16 weeks)
- Change in eating behaviors(Baseline up to 16 weeks)
- Change in leptin(Baseline up to 16 weeks)
- Change in insulin(Baseline up to 16 weeks)
- Change in adiponectin(Baseline up to 16 weeks)
- Change in resistin(Baseline up to 16 weeks)
- Change in IGFBP-3(Baseline up to 16 weeks)
- Change in TNF-alpha(Baseline up to 16 weeks)
- Change in IGF-1(Baseline up to 16 weeks)
- Change in waist/hip circumference ratio as a measure of body composition(Baseline up to 16 weeks)
- Change in total body fat as a measure of body composition(Baseline up to 16 weeks)
- Average change in the Exercise Causality Orientations Scale (ECOS)(Baseline up to 16 weeks)
- Change in IGFBP-1(Baseline up to 16 weeks)