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

May 27, 2015 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Institute of medical physics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: baseline, 12 month
baseline, 12 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Siemens-Betriebskrankenkasse

Investigators

  • Study Director: Wolfgang Kemmler, PhD, University of Erlangen-Nürnberg Medical School
  • Principal Investigator: Michael Bebenek, MS, University of Erlangen-Nürnberg Medical School
  • Study Chair: Willi A Kalender, Professor, PhD, University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFZ-Trace

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe