- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00668174
Effect of Exercise on Sex Hormones in Postmenopausal Women
26. november 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
173
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Washington
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Seattle, Washington, Forenede Stater, 98102
- Fred Hutchinson Cancer Research Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 2
Styring
|
|
Eksperimentel: 1
Dyrke motion
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Serum total estrone concentration
Tidsramme: Baseline, 3 month, 12-month
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Baseline, 3 month, 12-month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).
Tidsramme: baseline, 3 month, 12-month
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baseline, 3 month, 12-month
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Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).
Tidsramme: Basline, 3 month, 12-month
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Basline, 3 month, 12-month
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Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas
Tidsramme: Baseline, 3 month, 12 month
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Baseline, 3 month, 12 month
|
Fasting serum concentrations of insulin, glucose, and triglycerides
Tidsramme: Baseline, 3 month, 12 month
|
Baseline, 3 month, 12 month
|
Quality of life
Tidsramme: Baseline, 3 month, 12 month
|
Baseline, 3 month, 12 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Campbell 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.
- Boynton 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.
- Tworoger 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.
- Rhew 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.
- Chubak 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.
- Bowen 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.
- 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.
- Chubak J, Ulrich CM, Tworoger SS, Sorensen B, Yasui Y, Irwin ML, Stanczyk FZ, Potter JD, McTiernan A. Effect of exercise on bone mineral density and lean mass in postmenopausal women. Med Sci Sports Exerc. 2006 Jul;38(7):1236-44. doi: 10.1249/01.mss.0000227308.11278.d7.
- Mohanka M, Irwin M, Heckbert SR, Yasui Y, Sorensen B, Chubak J, Tworoger SS, Ulrich CM, McTiernan A. Serum lipoproteins in overweight/obese postmenopausal women: a one-year exercise trial. Med Sci Sports Exerc. 2006 Feb;38(2):231-9. doi: 10.1249/01.mss.0000184584.95000.e4.
- Chubak J, Tworoger SS, Yasui Y, Ulrich CM, Stanczyk FZ, McTiernan A. Associations between reproductive and menstrual factors and postmenopausal androgen concentrations. J Womens Health (Larchmt). 2005 Oct;14(8):704-12. doi: 10.1089/jwh.2005.14.704.
- Frank LL, Sorensen BE, Yasui Y, Tworoger SS, Schwartz RS, Ulrich CM, Irwin ML, Rudolph RE, Rajan KB, Stanczyk F, Bowen D, Weigle DS, Potter JD, McTiernan A. Effects of exercise on metabolic risk variables in overweight postmenopausal women: a randomized clinical trial. Obes Res. 2005 Mar;13(3):615-25. doi: 10.1038/oby.2005.66.
- McTiernan A, Sorensen B, Yasui Y, Tworoger SS, Ulrich CM, Irwin ML, Rudolph RE, Stanczyk FZ, Schwartz RS, Potter JD. No effect of exercise on insulin-like growth factor 1 and insulin-like growth factor binding protein 3 in postmenopausal women: a 12-month randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1020-1. doi: 10.1158/1055-9965.EPI-04-0834. No abstract available.
- Irwin ML, McTiernan A, Baumgartner RN, Baumgartner KB, Bernstein L, Gilliland FD, Ballard-Barbash R. Changes in body fat and weight after a breast cancer diagnosis: influence of demographic, prognostic, and lifestyle factors. J Clin Oncol. 2005 Feb 1;23(4):774-82. doi: 10.1200/JCO.2005.04.036.
- Foster-Schubert KE, McTiernan A, Frayo RS, Schwartz RS, Rajan KB, Yasui Y, Tworoger SS, Cummings DE. Human plasma ghrelin levels increase during a one-year exercise program. J Clin Endocrinol Metab. 2005 Feb;90(2):820-5. doi: 10.1210/jc.2004-2081. Epub 2004 Dec 7.
- Irwin ML, Tworoger SS, Yasui Y, Rajan B, McVarish L, LaCroix K, Ulrich CM, Bowen D, Schwartz RS, Potter JD, McTiernan A. Influence of demographic, physiologic, and psychosocial variables on adherence to a yearlong moderate-intensity exercise trial in postmenopausal women. Prev Med. 2004 Dec;39(6):1080-6. doi: 10.1016/j.ypmed.2004.04.017.
- Chubak J, Tworoger SS, Yasui Y, Ulrich CM, Stanczyk FZ, McTiernan A. Associations between reproductive and menstrual factors and postmenopausal sex hormone concentrations. Cancer Epidemiol Biomarkers Prev. 2004 Aug;13(8):1296-301.
- Frankenfeld CL, McTiernan A, Aiello EJ, Thomas WK, LaCroix K, Schramm J, Schwartz SM, Holt VL, Lampe JW. Mammographic density in relation to daidzein-metabolizing phenotypes in overweight, postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2004 Jul;13(7):1156-62.
- McTiernan A, Tworoger SS, Rajan KB, Yasui Y, Sorenson B, Ulrich CM, Chubak J, Stanczyk FZ, Bowen D, Irwin ML, Rudolph RE, Potter JD, Schwartz RS. Effect of exercise on serum androgens in postmenopausal women: a 12-month randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2004 Jul;13(7):1099-105.
- Aiello EJ, Yasui Y, Tworoger SS, Ulrich CM, Irwin ML, Bowen D, Schwartz RS, Kumai C, Potter JD, McTiernan A. Effect of a yearlong, moderate-intensity exercise intervention on the occurrence and severity of menopause symptoms in postmenopausal women. Menopause. 2004 Jul-Aug;11(4):382-8. doi: 10.1097/01.gme.0000113932.56832.27.
- Tworoger SS, Chubak J, Aiello EJ, Yasui Y, Ulrich CM, Farin FM, Stapleton PL, Irwin ML, Potter JD, Schwartz RS, McTiernan A. The effect of CYP19 and COMT polymorphisms on exercise-induced fat loss in postmenopausal women. Obes Res. 2004 Jun;12(6):972-81. doi: 10.1038/oby.2004.119.
- Shade ED, Ulrich CM, Wener MH, Wood B, Yasui Y, Lacroix K, Potter JD, McTiernan A. Frequent intentional weight loss is associated with lower natural killer cell cytotoxicity in postmenopausal women: possible long-term immune effects. J Am Diet Assoc. 2004 Jun;104(6):903-12. doi: 10.1016/j.jada.2004.03.018.
- Atkinson C, Lampe JW, Tworoger SS, Ulrich CM, Bowen D, Irwin ML, Schwartz RS, Rajan BK, Yasui Y, Potter JD, McTiernan A. Effects of a moderate intensity exercise intervention on estrogen metabolism in postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2004 May;13(5):868-74.
- McTiernan A, Tworoger SS, Ulrich CM, Yasui Y, Irwin ML, Rajan KB, Sorensen B, Rudolph RE, Bowen D, Stanczyk FZ, Potter JD, Schwartz RS. Effect of exercise on serum estrogens in postmenopausal women: a 12-month randomized clinical trial. Cancer Res. 2004 Apr 15;64(8):2923-8. doi: 10.1158/0008-5472.can-03-3393.
- Tworoger SS, Yasui Y, Vitiello MV, Schwartz RS, Ulrich CM, Aiello EJ, Irwin ML, Bowen D, Potter JD, McTiernan A. Effects of a yearlong moderate-intensity exercise and a stretching intervention on sleep quality in postmenopausal women. Sleep. 2003 Nov 1;26(7):830-6. doi: 10.1093/sleep/26.7.830.
- Irwin ML, Yasui Y, Ulrich CM, Bowen D, Rudolph RE, Schwartz RS, Yukawa M, Aiello E, Potter JD, McTiernan A. Effect of exercise on total and intra-abdominal body fat in postmenopausal women: a randomized controlled trial. JAMA. 2003 Jan 15;289(3):323-30. doi: 10.1001/jama.289.3.323.
- Duggan C, Xiao L, Wang CY, McTiernan A. Effect of a 12-month exercise intervention on serum biomarkers of angiogenesis in postmenopausal women: a randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2014 Apr;23(4):648-57. doi: 10.1158/1055-9965.EPI-13-1155. Epub 2014 Feb 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 1997
Primær færdiggørelse (Faktiske)
1. december 2003
Studieafslutning (Faktiske)
1. december 2004
Datoer for studieregistrering
Først indsendt
25. april 2008
Først indsendt, der opfyldte QC-kriterier
25. april 2008
Først opslået (Skøn)
29. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PATH - CA/AG69334-01A2,
- IR-4290
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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