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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177761
First Posted: August 9, 2010
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
August 6, 2010
August 9, 2010
August 17, 2016
October 1998
December 2023   (Final data collection date for primary outcome measure)
  • overall-fractures (low-trauma) [ Time Frame: 16 year follow-up ]
    As assessed by questionnaire and structured interview
  • Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 16 year follow-up ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
  • overall-fractures [ Time Frame: Period between baseline and 12 year follow up ]
    As assessed by questionnaire and structured interview
  • Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 12 year follow-up ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
Complete list of historical versions of study NCT01177761 on ClinicalTrials.gov Archive Site
  • 10-year coronary heart disease (CHD) risk [ Time Frame: 16 year follow-up ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.
  • Metabolic Syndrome Z-Score [ Time Frame: 16 year follow-up ]
    Metabolic Syndrome Z-Score Index according to Johnson
  • Number of falls and injurious falls [ Time Frame: Recent 6 months before 12 year follow-up ]
    As assessed by questionnaires and structured interview.
  • 10-year CHD risk [ Time Frame: 12 year follow-up ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.
Not Provided
Not Provided
 
16 Year Follow-up of the Erlangen Fitness and Prevention Study.
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Osteopenia
  • Early Postmenopause
Procedure: physical exercise
Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
  • Active Comparator: exercise
    endurance,balance, power, resistance type exercise
    Intervention: Procedure: physical exercise
  • No Intervention: sedentary control
    Subjects were instructed to do not relevantly change their lifestyle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2023
December 2023   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
48 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01177761
OFZ-EFOPS16
No
Not Provided
Not Provided
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
  • Behinderten- und Versehrten-Sportverband Bayern e.V.
  • Netzwerk Knochengesundheit e.V.
Study Chair: Willi A Kalender, PHD, MD University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP