High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants
研究概览
简要总结
The goal of this research study is to learn if there is a level of exercise training that is more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers are found in the blood/tissue and may be related to your reaction to exercise.
This is an investigational study. Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Study Groups:
If you agree to take part in this research study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to each group:
- If you are in Group 1, you will take part in high-intensity interval (HIIT) exercise.
- If you are in Group 2, you will take part in moderate-intensity exercise.
- If you are in Group 3, you will not take part in any assigned exercise, but you will receive written materials and counseling by an exercise physiologist.
If you are in Group 1 or Group 2, you will also receive written materials and instructions on how to perform your exercises.
Physical Activity:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women [defined per provider discretion and notated in the medical record]
- •At high risk of developing breast cancer (history of Ductal Carcinoma In Situ (DCIS), Lobular Carcinoma In Situ (LCIS), Atypical Ductal Hyperplasia (ADH), Gail 5 year risk > 1.66% or lifetime risk > 20%)
- •Enrolled on the Longitudinal High Risk Cohort study or being seen in the Cancer Prevention Center.
- •Oriented to person, place, and time
- •BMI > or equal to 25 kg/m2
- •Speaks and reads English
排除标准
- •Underlying medical problems that contraindicate unsupervised exercise.
- •Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire (Appendix D).
- •Uses a walker or wheelchair/scooter
- •Is being treated for diagnosed diabetes or autoimmune disease
- •Lives outside the greater Houston area (Harris and contiguous counties)
- •Is pregnant (self-reported)
- •Is taking risk reduction therapy such as tamoxifen
- •Participants with a blood pressure >=140/90 at the time of baseline testing.
结局指标
主要结局
Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants
时间窗: 12 weeks
Trials judged feasible if: At least 45% of screened patients meet inclusion criteria, 2. At least 50% of patients who meet the inclusion criteria consent, 3. Adherence in HIIT and MICT is larger than 80%, and 4. Retention rate is larger than 80%.
次要结局
未报告次要终点