Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
調査の概要
詳細な説明
Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.
In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.
This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Utrecht、オランダ、3508 GA
- University Medical Center Utrecht, Julius Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Women aged 50 -69 year
- > 12 months since last menses
- Non-smokers (at least 12 months)
- Sedentary
- Knowledge of the Dutch language
- Agreement to be randomly assigned to either the exercise intervention or control group
- Informed consent to participate in all screening and study activities
Exclusion Criteria:
- Use of hormone replacement or oral contraceptives in past 6 months
- Morbidly obese (BMI > 40)
- BMI < 22
- Currently on or planning to go on a strict diet
- Ever diagnosed with breast cancer
- Diagnosis of other types of cancer in the past 5 years
- Diabetes mellitus or other endocrine related diseases
- Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
- Alcohol or drug abuse
- Maintenance use of corticosteroids
- Use of beta blockers
研究計画
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:防止
- 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
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 |
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インスリン感受性
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Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate
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Serum concentrations of endogenous androgens: testosterone, androstenedione
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Serum concentrations of sex hormone binding globulin
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Serum concentrations of fasting insulin
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二次結果の測定
結果測定 |
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血圧
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重さ
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体格指数 (BMI)
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薬の使用
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体力
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Amount of total body fat and intra-abdominal fat
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Body fat distribution
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Waist to hip ratio
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Lifestyle parameters (covariates)
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Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
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Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
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Alcohol consumption
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Reproductive factors
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Medical history
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jantine Schuit, PhD、Dutch Institute of Public Health and the Environment
- 主任研究者:Petra HM Peeters, PhD、University Medical Center Utrecht, Julius Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。