NCT02250053已完成不适用
The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
研究概览
简要总结
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed TNM stage II-III CC;
- •completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
- •≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
- •age ≥18 years;
- •written physician approval;
- •no additional surgery planned within the 6-month intervention (including colostomy reversal);
- •ability to walk unaided for 6-minutes;
- •no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.
排除标准
- •history of another primary invasive cancer (other than non-melanoma skin-cancer);
- •evidence of metastatic CC (i.e., TNM M1);
- •planning to receive any additional adjuvant chemotherapy;
- •pregnant or breast feeding;
- •unable to provide baseline blood sample;
- •cardiac conditions, including the following:
- •myocardial infarction or coronary revascularization procedure within prior 3 months;
- •uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
- •high-risk or uncontrolled arrhythmias;
- •clinically significant valvular disease;
- •decompensated heart failure;
- •known aortic aneurysm;
- •any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).
研究组 & 干预措施
exercise
Experimental
aerobic exercise on soluble intercellular adhesion molecules
干预措施: Exercise (Other)
结局指标
主要结局
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
时间窗: 2 years
次要结局
- Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;(6 months)
- Fasting insulin measured at baseline and six-months;(six months)
- Circulating tumor cells measured at baseline and six-months.(six months)
- Visceral adipose tissue and anthropometric measures at baseline and six-months;(6 months)
研究者
研究点 (1)
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