Effect of Exercise on Sex Hormones in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00668174
First received: April 25, 2008
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Breast Cancer Prevention
Behavioral: Exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Physical Activity and Total Health Trial

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Serum total estrone concentration [ Time Frame: Baseline, 3 month, 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG). [ Time Frame: baseline, 3 month, 12-month ] [ Designated as safety issue: No ]
  • Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1). [ Time Frame: Basline, 3 month, 12-month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Fasting serum concentrations of insulin, glucose, and triglycerides [ Time Frame: Baseline, 3 month, 12 month ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline, 3 month, 12 month ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: January 1997
Study Completion Date: December 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: 2
Control

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668174

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
  More Information

Publications:

Responsible Party: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00668174     History of Changes
Other Study ID Numbers: PATH - CA/AG69334-01A2,, IR-4290
Study First Received: April 25, 2008
Last Updated: November 26, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014