Effect of Exercise on Sex Hormones in Postmenopausal Women

Completed · Phase 2/Phase 3

Conditions studied: Breast Cancer Prevention

In brief

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.

Key facts

Study ID

NCT00668174

Run by

Fred Hutchinson Cancer Center

People needed

173

Starts

1997-01-01

Expected to finish

2004-12-01

Last updated by the study team

2012-11-28

Who can join

Age: 50 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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