Effect of Exercise on Sex Hormones in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity and Total Health Trial

Conditions
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Breast Cancer Prevention

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Exercise | Behavioral: Exercise<br>* Moderate intensity exercise, 5 days per week, 45 min per session, 50-70% max HR, divided into a 3-month individualized and 9-month maintenance period.<br>|
| No Intervention: 2<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total estrone concentration |  | Baseline, 3 month, 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |