Football Fitness After Breast Cancer (FFABC)
2021年9月30日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
69
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Copenhagen、デンマーク、2100
- University Hospital of Copenhagen, Rigshospitalet
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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介入なし：Control group
Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean change in whole-body fat mass from baseline to month 6 and month 12.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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).
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年3月20日
一次修了 (実際)
2019年11月30日
研究の完了 (実際)
2020年1月20日
試験登録日
最初に提出
2017年9月13日
QC基準を満たした最初の提出物
2017年9月13日
最初の投稿 (実際)
2017年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月1日
QC基準を満たした最後の更新が送信されました
2021年9月30日
最終確認日
2021年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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