Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Cardiovascular fitness
研究概览
简要总结
The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:
- Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
- Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants
Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.
Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Doesn´t exist. Patients were allocated depending their preferences
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
- •Women with chemotherapy and radiotherapy phase complete.
- •Women with post-surgery phase complete.
- •Women that are within 5 years from diagnostic.
- •ECOG Score above or equal to 0 or 1.
排除标准
- •Submit medical contraindications to physical exercise by their reference doctor.
- •Women in state IV o methastasis.
- •Pregnant women.
- •Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.
结局指标
主要结局
Cardiovascular fitness
时间窗: 16 weeks
Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.
次要结局
- Body composition(16 weeks)
- Physical functionality(16 weeks)
- Exercise adherence(16 weeks)
- Physical activity Levels(16 weeks)
- Fatigue levels(16weeks)
- Quality of life and health(16 weeks)
- Anxiety and depression levels(16 weeks)
研究者
Soraya Casla Barrio
Director of Oncologic Physical Exercise Area and PhD in Exercise Psychology
Tigers Running Club