Breast Neoplasm FemaleFFABCNCT03284567
Football Fitness After Breast Cancer
A study testing Football fitness in people with Breast Neoplasm Female, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Football fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Mar 2017to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
About this study
Official title: 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.
- Conditions
- Breast Neoplasm Female
- Being tested
- Football fitness
- Keywords
- Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition, Fitness, Aerobic capacity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Football fitnessBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Football fitness |
| Control group | No intervention | Participants in the control group will receive verbal advice about the benefits of exercise and physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Incremental test to exhaustion on a cycle ergometer.
Measured: 6 months and 12 months.
Secondary outcomes (15)
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 month and 12 month.
Mean change in balance from baseline to month 6 and month 12.
Single-leg flamingo balance test.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 6 month and 12 month.
Mean change in total body and leg bone mineral content (BMC).
Assessed by dual energy x-ray absorptiometry.
Measured: 6 month and 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start20 Mar 2017
- Primary completion30 Nov 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Jacob Uth, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284567
- Sponsor's protocol ID
- FFABC
- Acronym
- FFABC
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2017
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33423594Uth 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.
PubMed 32800792
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT03284567
- Acronym / sponsor ID
- FFABC / FFABC
- Conditions
- Breast Neoplasm Female
- Keywords
- Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Football fitness | Active comparator | Behavioral: Football fitnessParticipants 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. |
| Control group | No intervention | –Participants in the control group will receive verbal advice about the benefits of exercise and physical activity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Football fitnessThe 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 | Behavioural | Football fitness |
Primary outcome
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.
15 secondary outcomes
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Time frame: 6 months and 12 months.
Mean change in whole-body weight from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in whole-body muscle mass from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in muscle strength from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in balance from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in blood pressure from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in cholesterol from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Self-reported physical activity from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Self-reported functional level in upper extremities from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Self-reported health related quality of life from baseline to month 6 and month 12.
Time frame: 6 month and 12 month.
Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
Time frame: 6 month and 12 month.
Mean change in total body and leg bone mineral content (BMC).
Time frame: 6 month and 12 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 33423594Bloomquist 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.
- Derived from this study: PubMed 32800792Uth 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.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasm Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Football fitness in people with Breast Neoplasm Female, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12. (time frame: 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.