EXERT-BC Cardio: Randomized Study of EXErcise Regimens After Treatment for Breast Cancer Utilizing Cardio or Conditioning Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Muscle Mass
研究概览
简要总结
In this study, the investigators hypothesize that observed intense resistance training with conditioning elicits similar changes in body composition, muscle mass, and blood pressure as that with cardiovascular training (or cardio) for women treated with breast cancer.
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
- None
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-89 years
- •Women prescribed exercise as a SOC
- •Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
- •Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
- •Women with > 3 months of resistance training experience under expert guidance by a CSCS
- •Must be able to read and understand English and consent for themselves.
排除标准
- •Any current treatment with cytotoxic chemotherapy for breast cancer
- •Inability to safely engage in group sessions of resistance training as deemed by study PI
- •Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
- •Beta blocker or GLP-1 inhibitor medications
- •Pregnant women
研究组 & 干预措施
Cardio Training
干预措施: Resistance Training with Cardio (Behavioral)
Conditioning Training
干预措施: Resistance Training with Conditioning (Behavioral)
结局指标
主要结局
Change in Muscle Mass
时间窗: Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).
Measured as total muscle mass (kg), determined via InBody 970 bioimpedance analysis and ultrasound (BodyMetrix) for muscle tissue thickness.
Change in Fat Mass
时间窗: Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).
Measured as total fat mass (kg), determined via InBody 970 bioimpedance analysis and ultrasound (BodyMetrix) for adipose tissue thickness.
次要结局
- Change in Blood Pressure(Baseline (Prior to Program), at Month 1, and At Exercise Program Completion (approximately 2 months).)
- Change in Resting Metabolic Rate(At Exercise Program Completion (approximately 2 months).)
- Change in Body Composition Metrics (Other than Muscle/Fat Mass)(Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).)
- Change in Phase Angle(Baseline (Prior to Program) and At Exercise Program Completion (approximately 2 months).)
- Exercise Adherence(Throughout the Exercise Program (approximately 2 months).)
- Change in Grip Strength(Baseline (Prior to Program), During Exercise Program (before and after each workout), and At Exercise Program Completion (approximately 2 months).)
研究者
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)