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临床试验/NCT00359060
NCT00359060已完成3 期

Physical Activity and Breast Cancer Risk in Postmenopausal Women: the SHAPE Study

UMC Utrecht2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
UMC Utrecht
入组人数
180
试验地点
2
主要终点
Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate

研究概览

简要总结

Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate

Serum concentrations of endogenous androgens: testosterone, androstenedione

Serum concentrations of sex hormone binding globulin

Serum concentrations of fasting insulin

Insulin sensitivity

次要结局

  • Physical Fitness
  • Amount of total body fat and intra-abdominal fat
  • Weight
  • Body Mass Index (BMI)
  • Body fat distribution
  • Waist to hip ratio
  • Blood pressure
  • Lifestyle parameters (covariates)
  • Exercise behaviour (habitual physical activity, past week activity, physical activity in the past)
  • Diet (daily caloric intake; percent daily calories from fat, carbohydrates and proteins)
  • Alcohol consumption
  • Medication use
  • Reproductive factors
  • Medical history

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (2)

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