Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in Physical Activity Level
研究概览
简要总结
The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.
详细描述
The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors. Participants will undergo baseline testing at Dana-Farber or Yale, including administration of questionnaires to assess quality of life and the presence of cancer and treatment-related symptoms, fasting blood draw, and evaluation of body composition (using dual energy X-ray absorptiometry (DEXA). Participants will then take part in the 12-week LIVESTRONG Program or will be assigned to a wait-list control group. All measurements will be repeated at Dana-Farber or Yale after the 12-week exercise program or control period.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer diagnosis excluding non-melanoma skin cancer
- •Physically able to exercise
- •Able to complete forms and understand instructions in English
- •Agrees to be randomly assigned to either exercise or wait-list control group
- •Willing and able to attend one of the LIVESTRONG at the YMCA programs for 12 weeks
- •Willing and able to complete the baseline and 3-month clinic visits
排除标准
- •> 80 years of age
- •< 18 years of age
- •Recent (past 6 months) stroke/myocardial infarction or congestive heart failure/documented ejection fraction < 40%
- •Plans to undergo a major surgical procedure in the next 6 months
- •Presence of dementia or major psychiatric disease that would preclude participation in a group-based exercise program
- •Pregnant women or women intending to become pregnant
结局指标
主要结局
Change in Physical Activity Level
时间窗: 3 months
Modifiable Physical Activity Questionnaire will be used to assess physical activity levels at baseline and 3-months to examine whether the LIVESTRONG program led to maintenance or further increases in physical activity levels compared with participants randomized to control.
次要结局
- Change in Blood Biomarkers(12 weeks)
- Change in Body Fat Percentage(3 months)
- Change in Lean Body Mass(3 months)
- Change in Bone Mineral Density(3 months)
- Change in Body Mass Index (BMI)(3 months)