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Completed

NCT Number: NCT00668174

Effect of Exercise on Sex Hormones in Postmenopausal Women

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.

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Key information

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Serum total estrone concentration

    Time frame: Baseline, 3 month, 12-month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

Physical Activity and Total Health Trial

Important dates

Study start
1997
Primary completion
2003
Study completion
2004
First posted
Apr 29, 2008
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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