A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cardiopulmonary Fitness
研究概览
简要总结
Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of early-stage breast cancer (I-III)
- •Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
- •Able to communicate in English
排除标准
- •Pregnancy
- •Metastatic disease (Stage IV)
- •Unable or unwilling to complete cardiopulmonary exercise test
结局指标
主要结局
Cardiopulmonary Fitness
时间窗: post-intervention (16 weeks)
VO2peak assessed using cardiopulmonary exercise test
次要结局
- Visceral adipose tissue(post-intervention (16 weeks))
- hemoglobin A1c(post-intervention (16 weeks))
- lipid profile(post-intervention (16 weeks))
- Left ventricular ejection fraction(post-intervention (16 weeks))
- Native myocardial T1 time(post-intervention (16 weeks))
- Fasting glucose(post-intervention (16 weeks))
- Psychosocial Stress(post-intervention (16 weeks))
- Depressive symptoms(post-intervention (16 weeks))
- Left ventricular mass(post-intervention (16 weeks))
- Cancer-related fatigue(post-intervention (16 weeks))
- Cancer-specific, health-related quality of life(post-intervention (16 weeks))
研究者
Amy Kirkham
Assistant Professor
University of Toronto