Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Maximum oxygen uptake - ( VO2 peak)
研究概览
简要总结
Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.
There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy
The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.
The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.
Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).
Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Primary outcome (VO2 peak) Physiological tests assessors blinded
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
- •Diagnosed with colorectal cancer in adjuvant chemotherapy
- •Age 18+ years
- •WHO performance status of 0 or 1
- •Undergone surgery at least 6 weeks ago
- •Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.
排除标准
- •Myocardial infarction within the past six months
- •Symptomatic heart failure
- •Known angina pectoris
- •Contraindication for moderate to strenuous physical activity
结局指标
主要结局
Maximum oxygen uptake - ( VO2 peak)
时间窗: 12 weeks
Assessed with objective physiological test
次要结局
- Dual Energy X-ray Absorptiometry scan(From baseline to 39 weeks)
- Symptoms and side-effects(From baseline to 39 weeks)
- Health related Quality of Life(From baseline to 39 weeks)
- Anxiety and Depression(From baseline to 39 weeks)
- Lifestyle factors(From baseline to 39 weeks)
- Blood cholesterols(From baseline to 39 weeks)
- Physical activity level(From baseline to 39 weeks)
- Blood pressure / pulse(From 6 to 12 weeks)
- Pedometer Step Count(From baseline to 12 weeks)
研究者
Christina Andersen
RN, MPH, Ph.D.
Rigshospitalet, Denmark
