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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-11-30

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).

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Detailed Description

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Conditions

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Bone Diseases Metabolic Syndrome X Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

exercise (3 sessions/week)

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

exercise: 3 joint sessions/week for 12 months

2

exercise and "phytoestrogen" (cimicifuga racemosa)

Group Type ACTIVE_COMPARATOR

exercise + cimicifuga racemosa

Intervention Type BEHAVIORAL

exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)

3

wellness control, placebo

Group Type PLACEBO_COMPARATOR

wellness control, placebo

Intervention Type BEHAVIORAL

2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Interventions

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exercise

exercise: 3 joint sessions/week for 12 months

Intervention Type BEHAVIORAL

exercise + cimicifuga racemosa

exercise: 3 sessions/week for 12 months,cimicifuga racemosa (40 mg/d)

Intervention Type BEHAVIORAL

wellness control, placebo

2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months, placebo

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes