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16 Year Follow-up of the Erlangen Fitness and Prevention Study. (EFOPS)

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ClinicalTrials.gov Identifier: NCT01177761
Recruitment Status : Active, not recruiting
First Posted : August 9, 2010
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Behinderten- und Versehrten-Sportverband Bayern e.V.
Netzwerk Knochengesundheit e.V.
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Early Postmenopause Procedure: physical exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. A 16 Year Follow-up of the Erlangen Fitness and Prevention Study.
Study Start Date : October 1998
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. overall-fractures (low-trauma) [ Time Frame: 16 year follow-up ]
    As assessed by questionnaire and structured interview

  2. Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 16 year follow-up ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)


Secondary Outcome Measures :
  1. 10-year coronary heart disease (CHD) risk [ Time Frame: 16 year follow-up ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.

  2. Metabolic Syndrome Z-Score [ Time Frame: 16 year follow-up ]
    Metabolic Syndrome Z-Score Index according to Johnson



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Ages Eligible for Study:   48 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177761


Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Bavaria, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wolfgang Kemmler, Professor Dr. Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01177761     History of Changes
Other Study ID Numbers: OFZ-EFOPS16
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School:
Osteoporosis
exercise
fractures
Bone Mineral Density
CHD-risk

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases