The Erlangen Fitness and Prevention Study (EFOPS). (EFOPS)

November 28, 2023 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.

The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
    • Bavaria
      • Erlangen, Bavaria, Germany, 91052
        • Institute of Medical Physics, University of Erlangen-Nurnberg

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

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • participants of the EFOPS-study,
  • 12 years of exercise training according to the EFOPS-protocol (exercise).

Exclusion Criteria:

  • medication and diseases affecting bone metabolism,
  • inflammable diseases,
  • cardiovascular diseases,
  • start of relevant physical exercise programs beside the EFOPS protocol.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: exercise
endurance,balance, power, resistance type exercise
Procedure: physical exercise
Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
No Intervention: sedentary control
Subjects were instructed to do not relevantly change their lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall-fractures (low-trauma)
Time Frame: 16 year follow-up
As assessed by questionnaire and structured interview
16 year follow-up
Bone Mineral Density at Lumbar Spine and Proximal Femur
Time Frame: 16 year follow-up
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
16 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-year coronary heart disease (CHD) risk
Time Frame: 16 year follow-up
As assessed by Framingham Risk Factor Calculator according to Wilson.
16 year follow-up
Metabolic Syndrome Z-Score
Time Frame: 16 year follow-up
Metabolic Syndrome Z-Score Index according to Johnson
16 year follow-up

Collaborators and Investigators

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

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Behinderten- und Versehrten-Sportverband Bayern e.V.
Netzwerk Knochengesundheit e.V.

Investigators

  • Study Chair: Willi A Kalender, PHD, MD, 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

Helpful Links

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

October 1, 1998

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimated)

August 9, 2010

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFZ-EFOPS

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.

Clinical Trials on Osteoporosis

Clinical Trials on physical exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe