Effect of Exercise on Sex Hormones in Postmenopausal Women

November 26, 2012 updated by: Fred Hutchinson Cancer Center

Physical Activity and Total Health Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98102
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Control
Experimental: 1
Exercise
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).
Time Frame: baseline, 3 month, 12-month
baseline, 3 month, 12-month
Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).
Time Frame: Basline, 3 month, 12-month
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
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month
Fasting serum concentrations of insulin, glucose, and triglycerides
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month
Quality of life
Time Frame: Baseline, 3 month, 12 month
Baseline, 3 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • PATH - CA/AG69334-01A2,
  • IR-4290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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