Football Fitness After Breast Cancer (FFABC)

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Behavioral: Football fitness

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • University Hospital of Copenhagen, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Football fitness; 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
No Intervention: Control group; Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: University of Southern Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Breast cancer; Body composition; Fitness; Physical exercise; Aerobic capacity; Football; Late effects; Bone mineralization; Soccer training
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FFABC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No