NCT04449809撤回不适用
Pilot Study of the Feasibility of an Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions
研究概览
简要总结
The purpose of this research study is to find out if a monitored group exercise program can increase strength, muscle mass and ability to move in women after treatment for early stage breast cancer.
详细描述
This trial will assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements in a group of women treated for early stage breast cancer with the goal of improving functional mobility, body composition, and strength after breast conservation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 30-70 years
- •Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
- •Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted)
- •BMI > 25 kg/m2 or body fat% greater or equal to 31%
- •Participants must have abstained from smoking for at least 12 months
- •Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment and have undergone a pregnancy test prior to initial of radiation therapy (standard protocol for radiation therapy). They should also consent to use adequate contraception during the course of the study.
- •Women must be determined capable of engaging in resistance training as documented in treating radiation oncologist notes.
- •Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day.
- •Women must complete a Functional Mobility Screen (FMS) and determined safe to engage in the workout regimen by the study personnel.
排除标准
- •Any treatment with chemotherapy for recent breast cancer treatment
- •Mastectomy and/or lymph node dissection
- •Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, and hemoglobin A1c greater than 8.
- •Diabetic condition requiring the usage of insulin
- •Severe arthritic, joint, cardiovascular, or musculoskeletal condition
- •Inability to perform body weight squat exercise without pain assessed by treating radiation oncologist
- •History of myocardial infarction or coronary artery disease
结局指标
主要结局
Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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