Football Fitness After Breast Cancer (FFABC)
2021년 9월 30일 업데이트: Jacob Uth, University of Copenhagen
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.
연구 개요
연구 유형
중재적
등록 (실제)
69
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Copenhagen, 덴마크, 2100
- University Hospital of Copenhagen, Rigshospitalet
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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. |
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 |
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간섭 없음: Control group
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
기간: 6 months and 12 months.
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Incremental test to exhaustion on a cycle ergometer.
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6 months and 12 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean change in whole-body fat mass from baseline to month 6 and month 12.
기간: 6 months and 12 months.
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Assessed by dual energy x-ray absorptiometry.
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6 months and 12 months.
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Mean change in whole-body weight from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Body weight was measured with a digital platform scale.
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6 month and 12 month.
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Mean change in whole-body muscle mass from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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Mean change in muscle strength from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Dynamic concentric muscle strength for the knee extensors (1RM).
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6 month and 12 month.
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Mean change in balance from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Single-leg flamingo balance test.
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6 month and 12 month.
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Mean change in blood pressure from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Blood pressure will be measured with a digital sphygmomanometer.
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6 month and 12 month.
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Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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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.
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6 month and 12 month.
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Mean change in cholesterol from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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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).
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6 month and 12 month.
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Self-reported physical activity from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by the International Physical Activity Questionnaire (IPAQ).
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6 month and 12 month.
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Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by the supplement EORTC QLQ-BR23.
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6 month and 12 month.
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Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
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6 month and 12 month.
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Self-reported functional level in upper extremities from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by disabilities of the arm, shoulder and hand (DASH).
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6 month and 12 month.
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Self-reported health related quality of life from baseline to month 6 and month 12.
기간: 6 month and 12 month.
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Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
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6 month and 12 month.
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Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
기간: 6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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Mean change in total body and leg bone mineral content (BMC).
기간: 6 month and 12 month.
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Assessed by dual energy x-ray absorptiometry.
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6 month and 12 month.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 3월 20일
기본 완료 (실제)
2019년 11월 30일
연구 완료 (실제)
2020년 1월 20일
연구 등록 날짜
최초 제출
2017년 9월 13일
QC 기준을 충족하는 최초 제출
2017년 9월 13일
처음 게시됨 (실제)
2017년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 30일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
유방 신생물 여성에 대한 임상 시험
Football fitness에 대한 임상 시험
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