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| Name | Class |
|---|---|
| Siemens-Betriebskrankenkasse | INDUSTRY |
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The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | exercise (3 sessions/week) |
|
| 2 | Active Comparator | exercise and "phytoestrogen" (cimicifuga racemosa) |
|
| 3 | Placebo Comparator | wellness control, placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral | exercise: 3 joint sessions/week for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | baseline, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| body composition | baseline, 12 month | |
| blood lipids, glucose | baseline, 12 month | |
| blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bebenek, MS | University of Erlangen-Nürnberg Medical School | Principal Investigator |
| Wolfgang Kemmler, PhD | University of Erlangen-Nürnberg Medical School | Study Director |
| Willi A Kalender, Professor, PhD | University of Erlangen-Nürnberg Medical School | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Physics | Erlangen | 91052 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15159265 | Background | Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084. | |
| 17550916 |
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| exercise + cimicifuga racemosa |
| Behavioral |
exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d) |
|
| wellness control, placebo | Behavioral | 2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo |
|
| baseline, 12 month |
| 10 year CHD-risk | baseline, 12 months |
| menopausal complaints | baseline, 12 months |
| von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5. |
| 15692313 | Background | Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. doi: 10.1249/01.mss.0000152678.20239.76. |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D024821 | Metabolic Syndrome |
| D003327 | Coronary Disease |
| D016649 | Primary Ovarian Insufficiency |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C000713173 | black cohosh root extract |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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