Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause

Conditions
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Bone Diseases, Metabolic Syndrome X, Coronary Disease

Intervention / Treatment
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* Behavioral: exercise
* Behavioral: exercise + cimicifuga racemosa
* Behavioral: wellness control, placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-3 years early postmenopausal Caucasian race Exclusion Criteria: CHD-diseases thrombosis, embolism fractures at lumbar spine or hip secondary osteoporosis hyperparathyroidism medication, diseases with impact on muscle or bone cancer and hormone derived malign diseases weight reduction of > 5 kg during the last 6 months

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>exercise (3 sessions/week) | Behavioral: exercise<br>* exercise: 3 joint sessions/week for 12 months<br>|
| Active Comparator: 2<br>exercise and phytoestrogen (cimicifuga racemosa) | Behavioral: exercise + cimicifuga racemosa<br>* exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)<br>|
| Placebo Comparator: 3<br>wellness control, placebo | Behavioral: wellness control, placebo<br>* 2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | baseline, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | baseline, 12 month | 
| blood lipids, glucose |  | baseline, 12 month | 
| blood pressure |  | baseline, 12 month | 
| 10 year CHD-risk |  | baseline, 12 months | 
| menopausal complaints |  | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early menopause, exercise, phytoestrogen, bone, CHD-risk factors