Football Fitness After Breast Cancer (FFABC)
2021年9月30日 更新者：Jacob Uth、University of Copenhagen
A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer
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.
研究概览
研究类型
介入性
注册 (实际的)
69
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Copenhagen、丹麦、2100
- University Hospital of Copenhagen, Rigshospitalet
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- WHO performance level > 1.
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Football fitness
Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games. Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury. |
The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games. Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors |
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无干预：Control group
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
大体时间：6 months and 12 months.
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Incremental test to exhaustion on a cycle ergometer.
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6 months and 12 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean change in whole-body fat mass from baseline to month 6 and month 12.
大体时间：6 months and 12 months.
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Assessed by dual energy x-ray absorptiometry.
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6 months and 12 months.
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Mean change in whole-body weight from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Body weight was measured with a digital platform scale.
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6 month and 12 month.
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Mean change in whole-body muscle mass from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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Mean change in muscle strength from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Dynamic concentric muscle strength for the knee extensors (1RM).
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6 month and 12 month.
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Mean change in balance from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Single-leg flamingo balance test.
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6 month and 12 month.
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Mean change in blood pressure from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Blood pressure will be measured with a digital sphygmomanometer.
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6 month and 12 month.
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Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.
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6 month and 12 month.
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Mean change in cholesterol from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).
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6 month and 12 month.
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Self-reported physical activity from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by the International Physical Activity Questionnaire (IPAQ).
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6 month and 12 month.
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Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by the supplement EORTC QLQ-BR23.
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6 month and 12 month.
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Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
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6 month and 12 month.
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Self-reported functional level in upper extremities from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by disabilities of the arm, shoulder and hand (DASH).
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6 month and 12 month.
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Self-reported health related quality of life from baseline to month 6 and month 12.
大体时间：6 month and 12 month.
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Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
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6 month and 12 month.
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Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
大体时间：6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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Mean change in total body and leg bone mineral content (BMC).
大体时间：6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bloomquist K, Krustrup P, Fristrup B, Sorensen V, Helge JW, Helge EW, Soelberg Vadstrup E, Rorth M, Hayes SC, Uth J. Effects of football fitness training on lymphedema and upper-extremity function in women after treatment for breast cancer: a randomized trial. Acta Oncol. 2021 Mar;60(3):392-400. doi: 10.1080/0284186X.2020.1868570. Epub 2021 Jan 11.
- Uth J, Fristrup B, Sorensen V, Helge EW, Christensen MK, Kjaergaard JB, Moller TK, Mohr M, Helge JW, Jorgensen NR, Rorth M, Vadstrup ES, Krustrup P. Exercise intensity and cardiovascular health outcomes after 12 months of football fitness training in women treated for stage I-III breast cancer: Results from the football fitness After Breast Cancer (ABC) randomized controlled trial. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):792-799. doi: 10.1016/j.pcad.2020.08.002. Epub 2020 Aug 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月20日
初级完成 (实际的)
2019年11月30日
研究完成 (实际的)
2020年1月20日
研究注册日期
首次提交
2017年9月13日
首先提交符合 QC 标准的
2017年9月13日
首次发布 (实际的)
2017年9月15日
研究记录更新
最后更新发布 (实际的)
2021年10月1日
上次提交的符合 QC 标准的更新
2021年9月30日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Football fitness的临床试验
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Centre Hospitalier Universitaire de Saint Etienne完全的
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Pennington Biomedical Research CenterAmerican Diabetes Association; Louisiana State University, Baton Rouge; American Council on Exercise完全的
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Guillermo Ceballos ReyesInstituto de Seguridad y Servicios Sociales de los Trabajadores del Estado完全的