The Erlangen Fitness and Prevention Study (EFOPS).

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01177761
• Collaborator: Behinderten- und Versehrten-Sportverband Bayern e.V. (Other), Netzwerk Knochengesundheit e.V. (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 302
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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. The Long-term Erlangen Fitness and Prevention Study.
• Study Start Date: Oct 1, 1998
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. overall-fractures (low-trauma) [16 year follow-up]

   As assessed by questionnaire and structured interview

2. Bone Mineral Density at Lumbar Spine and Proximal Femur [16 year follow-up]

   As assessed by Dual-Energy X-ray Absorptiometry (DEXA)

Secondary Outcome Measures

1. 10-year coronary heart disease (CHD) risk [16 year follow-up]

   As assessed by Framingham Risk Factor Calculator according to Wilson.

2. Metabolic Syndrome Z-Score [16 year follow-up]

   Metabolic Syndrome Z-Score Index according to Johnson

Eligibility Criteria

Criteria

• Ages Eligible for Study: 48 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• homepage Institute of Medical Physics University of Erlangen-Nürnberg

Publications

• Kemmler W, von Stengel S, Bebenek M, Engelke K, Hentschke C, Kalender WA. Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2012 Apr;23(4):1267-76. doi: 10.1007/s00198-011-1663-5. Epub 2011 May 28.
• Kemmler W, von Stengel S. Dose-response effect of exercise frequency on bone mineral density in post-menopausal, osteopenic women. Scand J Med Sci Sports. 2014 Jun;24(3):526-34. doi: 10.1111/sms.12024. Epub 2012 Nov 28.

• Responsible Party: Wolfgang Kemmler, Professor Dr. Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT01177761
• Other Study ID Numbers: OFZ-EFOPS
• First Posted: Aug 9, 2010
• Last Update Posted: Jun 22, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Wolfgang Kemmler, Professor Dr. Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School: Osteoporosis; exercise; fractures; Bone Mineral Density; CHD-risk
• Additional relevant MeSH terms: Osteoporosis; Bone Diseases, Metabolic

Study Results

No Results Posted as of Jun 22, 2021