- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00668174
Effect of Exercise on Sex Hormones in Postmenopausal Women
2012년 11월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
173
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Washington
-
Seattle, Washington, 미국, 98102
- Fred Hutchinson Cancer Research Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 2
제어
|
|
실험적: 1
운동
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Serum total estrone concentration
기간: Baseline, 3 month, 12-month
|
Baseline, 3 month, 12-month
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).
기간: baseline, 3 month, 12-month
|
baseline, 3 month, 12-month
|
Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).
기간: 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
기간: Baseline, 3 month, 12 month
|
Baseline, 3 month, 12 month
|
Fasting serum concentrations of insulin, glucose, and triglycerides
기간: Baseline, 3 month, 12 month
|
Baseline, 3 month, 12 month
|
Quality of life
기간: Baseline, 3 month, 12 month
|
Baseline, 3 month, 12 month
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
1997년 1월 1일
기본 완료 (실제)
2003년 12월 1일
연구 완료 (실제)
2004년 12월 1일
연구 등록 날짜
최초 제출
2008년 4월 25일
QC 기준을 충족하는 최초 제출
2008년 4월 25일
처음 게시됨 (추정)
2008년 4월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 11월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 26일
마지막으로 확인됨
2012년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PATH - CA/AG69334-01A2,
- IR-4290
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
유방암 예방에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
Exercise에 대한 임상 시험
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한
-
The Hong Kong Polytechnic University완전한
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)완전한