Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Recruitment/Attendance/Drop-Out Rates
研究概览
简要总结
The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.
详细描述
Baseline Study Procedures:
If you agree to take part in the pretest portion of this study, your cardiology team will look at a number of tests performed on your heart as part of your usual care, as well as your complete medical history, to find out if you are eligible to take part in this study.
If you are found to be eligible to take part in this study, you will be scheduled for a visit to the Behavioral Research and Treatment Center (BRTC) at MD Anderson.
Before your first visit to the BRTC, you will complete the following tasks at home:
-You will wear an accelerometer to measure your physical activity for 1 week. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. You will bring the accelerometer with you when you come for your first visit in the BRTC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue;
- •previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation);
- •oriented to person, place, and time;
- •living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks.
- •18 years of age or older.
- •diagnosis of cancer
- •have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only
排除标准
- •remain in NYHA class IV heart failure despite therapy;
- •have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist;
- •cannot provide informed consent;
研究组 & 干预措施
Group 2
Exercise Training + Dietary Counseling
干预措施: Dietary Counseling (Behavioral)
Group 1
Usual Care
干预措施: Usual Care (Other)
Group 2
Exercise Training + Dietary Counseling
干预措施: Usual Care (Other)
Group 2
Exercise Training + Dietary Counseling
干预措施: Exercise Training (Behavioral)
结局指标
主要结局
Recruitment/Attendance/Drop-Out Rates
时间窗: 1 Year
次要结局
未报告次要终点