EXERT-BCH: Prospective Study of EXErcise Regimens After Treatment for Breast Cancer to Improve Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine changes in muscle and fat mass during and after each exercise regimen
研究概览
简要总结
The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.
详细描述
This protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast.
As part of the standard exercise program, patients will undergo a fitness evaluation at the AHNCI Exercise Oncology and Resiliency Center before the start of the exercise program. This evaluation will be used to customize the patient exercise program. The exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). The fitness evaluation and exercise program are standard of care. Participation in this study will last the duration of the exercise program, about 3 months. All group exercise sessions will be closely monitored by the center staff who are Certified Strength and Conditioning Specialists (CSCS).
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 with a biopsy proven diagnosis of ductal carcinoma in situ 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.
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
研究组 & 干预措施
Control Arm / ACSM Guidelines
The control group will follow resistance training guidelines from the American College of Sports Medicine (ACSM) with the goal of promoting hypertrophy
干预措施: Control Arm ACSM Guidelines (Other)
Experimental Arm / EOC Guidelines
The experimental group will use a regimen that is often used by strength and conditioning coaches to maximize hypertrophy, and is part of the standard regimens at the Exercise Oncology Center (EOC)
干预措施: Experimental Arm 6-12-25 repetitions per set (Other)
结局指标
主要结局
Determine changes in muscle and fat mass during and after each exercise regimen
时间窗: The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.
The experimental group will follow a 6-12-25 program geared at optimizing hypertrophy and metabolism via high volume and increased time under tension.
次要结局
- Determine changes in strength measured via load calculations (repetitions x sets x weight)(The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.)
- Determine adherence defined as number of sessions attended of total sessions(The exercise program will last for 8 weeks and continuously monitored by the PI and clinical team.)
研究者
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)