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Effect of Exercise on Sex Hormones in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668174
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : November 28, 2012
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Prevention Behavioral: Exercise Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Physical Activity and Total Health Trial
Study Start Date : January 1997
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Behavioral: Exercise
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.

No Intervention: 2

Primary Outcome Measures :
  1. Serum total estrone concentration [ Time Frame: Baseline, 3 month, 12-month ]

Secondary Outcome Measures :
  1. serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG). [ Time Frame: baseline, 3 month, 12-month ]
  2. Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1). [ Time Frame: Basline, 3 month, 12-month ]
  3. Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas [ Time Frame: Baseline, 3 month, 12 month ]
  4. Fasting serum concentrations of insulin, glucose, and triglycerides [ Time Frame: Baseline, 3 month, 12 month ]
  5. Quality of life [ Time Frame: Baseline, 3 month, 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668174

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Research Center Identifier: NCT00668174    
Other Study ID Numbers: PATH - CA/AG69334-01A2,
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012