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Completed

NCT Number: NCT03284567

Football Fitness After 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.

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Key information

Conditions

Breast Neoplasm Female Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.

    Time frame: 6 months and 12 months.

    Incremental test to exhaustion on a cycle ergometer.

Secondary outcomes

  1. Mean change in whole-body fat mass from baseline to month 6 and month 12.

    Time frame: 6 months and 12 months.

    Assessed by dual energy x-ray absorptiometry.

  2. Mean change in whole-body weight from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Body weight was measured with a digital platform scale.

  3. Mean change in whole-body muscle mass from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by dual energy x-ray absorptiometry.

  4. Mean change in muscle strength from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Dynamic concentric muscle strength for the knee extensors (1RM).

  5. Mean change in balance from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Single-leg flamingo balance test.

  6. Mean change in blood pressure from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Blood pressure will be measured with a digital sphygmomanometer.

  7. Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    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.

  8. Mean change in cholesterol from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    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).

  9. Self-reported physical activity from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by the International Physical Activity Questionnaire (IPAQ).

  10. Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by the supplement EORTC QLQ-BR23.

  11. Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).

  12. Self-reported functional level in upper extremities from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by disabilities of the arm, shoulder and hand (DASH).

  13. Self-reported health related quality of life from baseline to month 6 and month 12.

    Time frame: 6 month and 12 month.

    Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)

  14. Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.

    Time frame: 6 month and 12 month.

    Assessed by dual energy x-ray absorptiometry.

  15. Mean change in total body and leg bone mineral content (BMC).

    Time frame: 6 month and 12 month.

    Assessed by dual energy x-ray absorptiometry.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer

Acronym: FFABC

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 15, 2017
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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