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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Football fitness | Active Comparator | 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. |
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| Control group | No Intervention | Participants in the control group will receive verbal advice about the benefits of exercise and physical activity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Football fitness | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12. | Incremental test to exhaustion on a cycle ergometer. | 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in whole-body fat mass from baseline to month 6 and month 12. | Assessed by dual energy x-ray absorptiometry. | 6 months and 12 months. |
| Mean change in whole-body weight from baseline to month 6 and month 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Copenhagen, Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33423594 | Derived | 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. | |
| 32800792 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.
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Personnel assessing the primary outcome is blinded for study participants group allocation.
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Body weight was measured with a digital platform scale.
| 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. | 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). | 6 month and 12 month. |
| Mean change in balance from baseline to month 6 and month 12. | Single-leg flamingo balance test. | 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. | 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. | 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). | 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). | 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. | 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). | 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). | 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) | 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. | 6 month and 12 month. |
| Mean change in total body and leg bone mineral content (BMC). | Assessed by dual energy x-ray absorptiometry. | 6 month and 12 month. |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |