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

University of Copenhagen1 site in 1 country69 target enrollmentMarch 20, 2017

ConditionsBreast Neoplasm Female

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Neoplasm Female
Sponsor: University of Copenhagen
Enrollment: 69
Locations: 1
Primary Endpoint: Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 20, 2017

End Date

January 20, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Copenhagen

Responsible Party

Principal Investigator

Jacob Uth

Postdoc

University of Copenhagen

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 \>
•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).

Outcomes

Primary Outcomes

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

Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.(6 month and 12 month.)
Mean change in total body and leg bone mineral content (BMC).(6 month and 12 month.)
Mean change in whole-body fat mass from baseline to month 6 and month 12.(6 months and 12 months.)
Mean change in whole-body muscle mass from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in blood pressure from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in cholesterol from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in whole-body weight from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in muscle strength from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in balance from baseline to month 6 and month 12.(6 month and 12 month.)
Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.(6 month and 12 month.)
Self-reported physical activity from baseline to month 6 and month 12.(6 month and 12 month.)
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.(6 month and 12 month.)
Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.(6 month and 12 month.)
Self-reported functional level in upper extremities from baseline to month 6 and month 12.(6 month and 12 month.)
Self-reported health related quality of life from baseline to month 6 and month 12.(6 month and 12 month.)