Clinical trial NCT03284567: Football Fitness After Breast Cancer
Official title: A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Breast cancer
Football
Late effects
Physical exercise
Soccer training
Rehabilitation
Bone mineralization
Body composition
Fitness
Aerobic capacity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2017-09-15
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
timeFrame: 6 months and 12 months.
Secondary outcomes:
measure: Mean change in whole-body fat mass from baseline to month 6 and month 12.
timeFrame: 6 months and 12 months.
measure: Mean change in whole-body weight from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in whole-body muscle mass from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in muscle strength from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in balance from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in blood pressure from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in cholesterol from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Self-reported physical activity from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Self-reported functional level in upper extremities from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Self-reported health related quality of life from baseline to month 6 and month 12.
timeFrame: 6 month and 12 month.
measure: Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
timeFrame: 6 month and 12 month.
measure: Mean change in total body and leg bone mineral content (BMC).
timeFrame: 6 month and 12 month.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen, Rigshospitalet
Study officials:
References:
citation: 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.
citation: 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.