Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
研究概览
简要总结
Hypothesis 1: Exercise will decrease serum markers in a dose response manner.
Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.
详细描述
Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.
Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 to 80
- •no personal cancer history
- •found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
- •no contraindications to beginning an exercise program
- •no previous diagnosis of familial polyposis syndromes
- •no previous diagnosis of ulcerative colitis or Crohn's disease;
排除标准
- •Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.
研究组 & 干预措施
Arm A: 30 minutes walking
First Step program with 30 minutes of walking and 10,000 steps per day for 3 months.
干预措施: Walking (Behavioral)
Arm B: 60 minutes walking
First Step program with 60 minutes of walking and 13,000 steps per day for 3 months.
干预措施: Walking (Behavioral)
结局指标
主要结局
Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
时间窗: 3 months
Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels.
次要结局
- Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months.(3 months)