A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
研究概览
简要总结
Late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. However only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for 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
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Personnel assessing the primary outcome is blinded for study participants group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women surgically managed for breast cancer, local and regional advanced breast cancer.
- •Completion of adjuvant chemotherapy and radiation therapy.
- •Legally competent persons with ability to read and understand Danish.
- •Signed informed consent.
- •Performance level 0-1 (WHO).
排除标准
- •WHO performance level >
- •Osteoporosis (T-score < -2.5).
- •Known metastatic breast cancer (stage IV).
- •Women in DBCG-group I (age => 60 years, tumor =< 10 mm, invasive ductal carcinoma grade I, invasive lobular carcinoma grade I / II, estrogen receptor positive and HER2 normal).
- •Cardiovascular or pulmonary disorders (e.g., arrhythmias, ischemic heart disease, unregulated high blood pressure, chronic obstructive lung disease).
- •Ongoing anticoagulant therapy (vitamin K antagonists; Marevan, Marcoumar and low molecular weight heparins; Innohep, Clexane, Fragmin) for pulmonary embolism or deep venous thrombosis (DVT) due to increased bleeding risk of falls and clashes with other players during exercise.
- •Current or scheduled chemotherapy and radiation therapy in the intervention period (12 months).
结局指标
主要结局
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
时间窗: 6 months and 12 months.
Incremental test to exhaustion on a cycle ergometer.
次要结局
- Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.(6 month and 12 month.)
- Mean change in total body and leg bone mineral content (BMC).(6 month and 12 month.)
- Mean change in whole-body fat mass from baseline to month 6 and month 12.(6 months and 12 months.)
- Mean change in whole-body muscle mass from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in blood pressure from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in cholesterol from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in whole-body weight from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in muscle strength from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in balance from baseline to month 6 and month 12.(6 month and 12 month.)
- Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.(6 month and 12 month.)
- Self-reported physical activity from baseline to month 6 and month 12.(6 month and 12 month.)
- Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.(6 month and 12 month.)
- Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.(6 month and 12 month.)
- Self-reported functional level in upper extremities from baseline to month 6 and month 12.(6 month and 12 month.)
- Self-reported health related quality of life from baseline to month 6 and month 12.(6 month and 12 month.)
研究者
Jacob Uth
Postdoc
University of Copenhagen