NCT00668174已完成2 期
Physical Activity and Total Health Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Serum total estrone concentration
研究概览
简要总结
The goals of the study are to examine the effect in postmenopausal women of a one-year moderate intensity exercise intervention, as compared with a sedentary pattern (low-level stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin, triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 55-75 years at first group meeting
- •Physically able to undertake a moderate exercise program
- •Sedentary activity pattern (exercising < 2 times/week for 20 minutes at a level to produce sweating)
- •Postmenopausal (not experiencing menstrual periods for the previous 12 months or FSH >30 mIU/ml; for women who have had a hysterectomy, an FHS >30 mIU/ml will classify them as postmenopausal)
- •Body Mass Index (BMI) greater than 25.0
- •Able to follow directions and fill out questionnaires, and exercise diaries and logs in English
- •Agrees to be randomly assigned to either the exercise intervention or control group
- •Gives informed consent to participate in all screening and study activities
- •Able to come to the FHCRC for clinic visits and classes, to the UW Medical Center for CT scans, and to the UW NETT for measurements and instruction
排除标准
- •Plans to leave Western Washington within the follow-up period
- •Using hormone replacement, tamoxifen, or oral contraceptives in past 6 months
- •Currently having severe hot flashes (that might prompt participant to start hormone replacement therapy before the end of study)
- •Current unstable thyroid disease or unstable dose of thyroid medications or TSH >5.0 IU/ml or <0.5 IU/ml
- •Invasive cancer in the past 10 years (except nonmelanotic skin cancer)
- •Any other endocrinologic abnormality
- •Breast, endometrial, ovarian, or melanoma cancer or carcinoma-in-situ at any time
- •Morbidly obese (BMI > 40)
- •Current or planned use of corticosteroids
- •Currently on or planning to enter a structured weight loss program or to take diet drugs
- •Current use of certain other medications, such as any likely to interfere with adherence to an exercise program or likely to interfere with study outcomes
- •Moderate to high alcohol intake (more than 2 drinks per day)
- •Current smoker
- •Diabetes mellitus (fasting hyperglycemia)
- •Abnormal screening labs (hematocrit < 32 or > 48, white blood cells < 3.0 or > 15.0, potassium < 3.5 or > 5.0, fasting glucose > 140, creatinine > 2.0), or abnormalities on screening physical judged by study physicians to contraindicate participation in an exercise program
- •Contraindications for entry into a training program118 including: unstable angina, uncontrolled hypertension (systolic > 200, diastolic > 100), orthostatic hypotension (> 20), moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, third degree heart block, pericarditis, myocarditis, pulmonary/systemic embolism within the past 6 months, thrombophlebitis, ST displacement > 3 mm at rest, history of cardiac arrest)
- •Contraindications for exercise testing118 including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality
- •Meets criteria to stop screening exercise test118 as decided by overseeing physician (Dr. Schwartz or McTiernan)
- •volunteering in order to lose weight
- •alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
结局指标
主要结局
Serum total estrone concentration
时间窗: Baseline, 3 month, 12-month
次要结局
- serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).(baseline, 3 month, 12-month)
- Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).(Basline, 3 month, 12-month)
- Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas(Baseline, 3 month, 12 month)
- Fasting serum concentrations of insulin, glucose, and triglycerides(Baseline, 3 month, 12 month)
- Quality of life(Baseline, 3 month, 12 month)
研究者
研究点 (2)
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