An interventional study of Football fitness in Breast Neoplasm Female, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
Behavioral: Football fitness
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
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
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Incremental test to exhaustion on a cycle ergometer.
Time frame: 6 months and 12 months.
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Time frame: 6 months and 12 months.
Mean change in whole-body weight from baseline to month 6 and month 12.
Body weight was measured with a digital platform scale.
Time frame: 6 month and 12 month.
Mean change in whole-body muscle mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Time frame: 6 month and 12 month.
Mean change in muscle strength from baseline to month 6 and month 12.
Dynamic concentric muscle strength for the knee extensors (1RM).
Time frame: 6 month and 12 month.
Mean change in balance from baseline to month 6 and month 12.
Single-leg flamingo balance test.
Time frame: 6 month and 12 month.
Mean change in blood pressure from baseline to month 6 and month 12.
Blood pressure will be measured with a digital sphygmomanometer.
Time frame: 6 month and 12 month.
Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
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.
Time frame: 6 month and 12 month.
Mean change in cholesterol from baseline to month 6 and month 12.
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).
Time frame: 6 month and 12 month.
Self-reported physical activity from baseline to month 6 and month 12.
Assessed by the International Physical Activity Questionnaire (IPAQ).
Time frame: 6 month and 12 month.
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
Assessed by the supplement EORTC QLQ-BR23.
Time frame: 6 month and 12 month.
Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
Time frame: 6 month and 12 month.
Self-reported functional level in upper extremities from baseline to month 6 and month 12.
Assessed by disabilities of the arm, shoulder and hand (DASH).
Time frame: 6 month and 12 month.
Self-reported health related quality of life from baseline to month 6 and month 12.
Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Time frame: 6 month and 12 month.
Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
Assessed by dual energy x-ray absorptiometry.
Time frame: 6 month and 12 month.
Mean change in total body and leg bone mineral content (BMC).
Assessed by dual energy x-ray absorptiometry.
Time frame: 6 month and 12 month.
Plan to share: No
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University of Copenhagen