- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00359060
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 3단계
연락처 및 위치
연구 장소
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Utrecht, 네덜란드, 3508 GA
- University Medical Center Utrecht, Julius Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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인슐린 감수성
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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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2차 결과 측정
결과 측정 |
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혈압
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무게
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체질량지수(BMI)
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약물 사용
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체력
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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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jantine Schuit, PhD, Dutch Institute of Public Health and the Environment
- 수석 연구원: Petra HM Peeters, PhD, University Medical Center Utrecht, Julius Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .