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Football Fitness After Breast Cancer (FFABC)

Primary Purpose

Breast Neoplasm Female

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Football fitness
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm Female focused on measuring Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition, Fitness, Aerobic capacity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University Hospital of Copenhagen, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Football fitness

Control group

Arm Description

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.

Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.

Outcomes

Primary Outcome Measures

Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Incremental test to exhaustion on a cycle ergometer.

Secondary Outcome Measures

Mean change in whole-body fat mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Mean change in whole-body weight from baseline to month 6 and month 12.
Body weight was measured with a digital platform scale.
Mean change in whole-body muscle mass from baseline to month 6 and month 12.
Assessed by dual energy x-ray absorptiometry.
Mean change in muscle strength from baseline to month 6 and month 12.
Dynamic concentric muscle strength for the knee extensors (1RM).
Mean change in balance from baseline to month 6 and month 12.
Single-leg flamingo balance test.
Mean change in blood pressure from baseline to month 6 and month 12.
Blood pressure will be measured with a digital sphygmomanometer.
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.
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).
Self-reported physical activity from baseline to month 6 and month 12.
Assessed by the International Physical Activity Questionnaire (IPAQ).
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
Assessed by the supplement EORTC QLQ-BR23.
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).
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).
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)
Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
Assessed by dual energy x-ray absorptiometry.
Mean change in total body and leg bone mineral content (BMC).
Assessed by dual energy x-ray absorptiometry.

Full Information

First Posted
September 13, 2017
Last Updated
September 30, 2021
Sponsor
University of Copenhagen
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03284567
Brief Title
Football Fitness After Breast Cancer
Acronym
FFABC
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female
Keywords
Breast cancer, Football, Late effects, Physical exercise, Soccer training, Rehabilitation, Bone mineralization, Body composition, Fitness, Aerobic capacity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Personnel assessing the primary outcome is blinded for study participants group allocation.
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Football fitness
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Football fitness
Intervention Description
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 Outcome Measure Information:
Title
Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
Description
Incremental test to exhaustion on a cycle ergometer.
Time Frame
6 months and 12 months.
Secondary Outcome Measure Information:
Title
Mean change in whole-body fat mass from baseline to month 6 and month 12.
Description
Assessed by dual energy x-ray absorptiometry.
Time Frame
6 months and 12 months.
Title
Mean change in whole-body weight from baseline to month 6 and month 12.
Description
Body weight was measured with a digital platform scale.
Time Frame
6 month and 12 month.
Title
Mean change in whole-body muscle mass from baseline to month 6 and month 12.
Description
Assessed by dual energy x-ray absorptiometry.
Time Frame
6 month and 12 month.
Title
Mean change in muscle strength from baseline to month 6 and month 12.
Description
Dynamic concentric muscle strength for the knee extensors (1RM).
Time Frame
6 month and 12 month.
Title
Mean change in balance from baseline to month 6 and month 12.
Description
Single-leg flamingo balance test.
Time Frame
6 month and 12 month.
Title
Mean change in blood pressure from baseline to month 6 and month 12.
Description
Blood pressure will be measured with a digital sphygmomanometer.
Time Frame
6 month and 12 month.
Title
Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
Description
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.
Time Frame
6 month and 12 month.
Title
Mean change in cholesterol from baseline to month 6 and month 12.
Description
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).
Time Frame
6 month and 12 month.
Title
Self-reported physical activity from baseline to month 6 and month 12.
Description
Assessed by the International Physical Activity Questionnaire (IPAQ).
Time Frame
6 month and 12 month.
Title
Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
Description
Assessed by the supplement EORTC QLQ-BR23.
Time Frame
6 month and 12 month.
Title
Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
Description
Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
Time Frame
6 month and 12 month.
Title
Self-reported functional level in upper extremities from baseline to month 6 and month 12.
Description
Assessed by disabilities of the arm, shoulder and hand (DASH).
Time Frame
6 month and 12 month.
Title
Self-reported health related quality of life from baseline to month 6 and month 12.
Description
Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Time Frame
6 month and 12 month.
Title
Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
Description
Assessed by dual energy x-ray absorptiometry.
Time Frame
6 month and 12 month.
Title
Mean change in total body and leg bone mineral content (BMC).
Description
Assessed by dual energy x-ray absorptiometry.
Time Frame
6 month and 12 month.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
University Hospital of Copenhagen, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33423594
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.
Results Reference
derived
PubMed Identifier
32800792
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.
Results Reference
derived

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Football Fitness After Breast Cancer

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