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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Staedtler Stiftung, Nurnberg
Behinderten und Rehabilitations-Sportverband Bayern
Netzwerk Knochengesundheit e.V.
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01177761
First received: August 6, 2010
Last updated: November 25, 2013
Last verified: November 2013

August 6, 2010
November 25, 2013
October 1998
December 2023   (final data collection date for primary outcome measure)
  • overall-fractures [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by questionnaire and structured interview
  • Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
  • overall-fractures [ Time Frame: Period between baseline and 12 year follow up ] [ Designated as safety issue: No ]
    As assessed by questionnaire and structured interview
  • Bone Mineral Density at Lumbar Spine and Proximal Femur [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
Complete list of historical versions of study NCT01177761 on ClinicalTrials.gov Archive Site
  • Number of falls and injurious falls [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by questionnaires and structured interview.
  • 10-year CHD risk [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.
  • Number of falls and injurious falls [ Time Frame: Recent 6 months before 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by questionnaires and structured interview.
  • 10-year CHD risk [ Time Frame: 12 year follow-up ] [ Designated as safety issue: No ]
    As assessed by Framingham Risk Factor Calculator according to Wilson.
Not Provided
Not Provided
 
12 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 12 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 3 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 12 years of supervised exercise with 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
Female
48 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01177761
OFZ-EFOPS12
No
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
  • Staedtler Stiftung, Nurnberg
  • Behinderten und Rehabilitations-Sportverband Bayern
  • Netzwerk Knochengesundheit e.V.
Study Chair: Willi A Kalender, PHD, MD University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
November 2013

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