Clinical trial · Interventional
Effect of Exercise on Sex Hormones in Postmenopausal Women
Physical Activity and Total Health Trial
NCT00668174CI-TRIAL-00008549completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Exercise
- interventionNames
- Behavioral: Exercise
- type
- NO_INTERVENTION
- label
- 2
- description
- Control
Primary outcomes (1)
- measure
- Serum total estrone concentration
- timeFrame
- Baseline, 3 month, 12-month
Secondary outcomes (5)
- measure
- serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (26)
- RESULTCampbell PT, Wener MH, Sorensen B, Wood B, Chen-Levy Z, Potter JD, McTiernan A, Ulrich CM. Effect of exercise on in vitro immune function: a 12-month randomized, controlled trial among postmenopausal women. J Appl Physiol (1985). 2008 Jun;104(6):1648-55. doi: 10.1152/japplphysiol.01349.2007. Epub 2008 Apr 10. PMID 18403448
- RESULTBoynton A, Neuhouser ML, Sorensen B, McTiernan A, Ulrich CM. Predictors of diet quality among overweight and obese postmenopausal women. J Am Diet Assoc. 2008 Jan;108(1):125-30. doi: 10.1016/j.jada.2007.10.037. PMID 18155998
- RESULTTworoger SS, Sorensen B, Chubak J, Irwin M, Stanczyk FZ, Ulrich CM, Potter J, McTiernan A. Effect of a 12-month randomized clinical trial of exercise on serum prolactin concentrations in postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):895-9. doi: 10.1158/1055-9965.EPI-06-0701. PMID 17507612
- RESULTRhew I, Yasui Y, Sorensen B, Ulrich CM, Neuhouser ML, Tworoger SS, Chubak J, Bowen DJ, McTiernan A. Effects of an exercise intervention on other health behaviors in overweight/obese post-menopausal women. Contemp Clin Trials. 2007 Jul;28(4):472-81. doi: 10.1016/j.cct.2007.01.002. Epub 2007 Jan 12. PMID 17287149
- RESULTChubak J, McTiernan A, Sorensen B, Wener MH, Yasui Y, Velasquez M, Wood B, Rajan KB, Wetmore CM, Potter JD, Ulrich CM. Moderate-intensity exercise reduces the incidence of colds among postmenopausal women. Am J Med. 2006 Nov;119(11):937-42. doi: 10.1016/j.amjmed.2006.06.033. PMID 17071161
- RESULTBowen DJ, Fesinmeyer MD, Yasui Y, Tworoger S, Ulrich CM, Irwin ML, Rudolph RE, LaCroix KL, Schwartz RR, McTiernan A. Randomized trial of exercise in sedentary middle aged women: effects on quality of life. Int J Behav Nutr Phys Act. 2006 Oct 4;3:34. doi: 10.1186/1479-5868-3-34. PMID 17020620
- Littman AJ, Vitiello MV, Foster-Schubert K, Ulrich CM, Tworoger SS, Potter JD, Weigle DS, McTiernan A. Sleep, ghrelin, leptin and changes in body weight during a 1-year moderate-intensity physical activity intervention. Int J Obes (Lond). 2007 Mar;31(3):466-75. doi: 10.1038/sj.ijo.0803438. Epub 2006 Aug 15.