The Erlangen Fitness and Prevention Study (EFOPS).

NCT01177761 | Completed

• 1 other identifier: OFZ-EFOPS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Osteopenia; Early Postmenopause

Keywords

Osteoporosis; exercise; fractures; Bone Mineral Density; CHD-risk

Outcome Measures

Primary Outcomes (2)

• overall-fractures (low-trauma)

  As assessed by questionnaire and structured interview

  16 year follow-up

• Bone Mineral Density at Lumbar Spine and Proximal Femur

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

  16 year follow-up

Secondary Outcomes (2)

• 10-year coronary heart disease (CHD) risk

  16 year follow-up

• Metabolic Syndrome Z-Score

  16 year follow-up

Study Arms (2)

exercise

ACTIVE COMPARATOR

endurance,balance, power, resistance type exercise

Procedure: physical exercise

sedentary control

NO INTERVENTION

Subjects were instructed to do not relevantly change their lifestyle

Interventions

physical exercise PROCEDURE

Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training

exercise

Eligibility Criteria

• Age: 48 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Behinderten- und Versehrten-Sportverband Bayern e.V.: collaborator
• Netzwerk Knochengesundheit e.V.: collaborator

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, Bavaria, 91052, Germany

Location

Related Publications (8)

• 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.

  PMID: 21625881 BACKGROUND

• 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.

  PMID: 23190199 BACKGROUND

• Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.

  PMID: 16096715 RESULT

• Kemmler W, Engelke K, von Stengel S, Weineck J, Lauber D, Kalender WA. Long-term four-year exercise has a positive effect on menopausal risk factors: the Erlangen Fitness Osteoporosis Prevention Study. J Strength Cond Res. 2007 Feb;21(1):232-9. doi: 10.1519/R-20826.1.

  PMID: 17313298 RESULT

• Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.

  PMID: 15746294 RESULT

• Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.

  PMID: 15159265 RESULT

• Kemmler W, Wildt L, Engelke K, Pintag R, Pavel M, Bracher B, Weineck J, Kalender W. Acute hormonal responses of a high impact physical exercise session in early postmenopausal women. Eur J Appl Physiol. 2003 Sep;90(1-2):199-209. doi: 10.1007/s00421-003-0874-7. Epub 2003 Jul 9.

  PMID: 14504954 RESULT

• Kemmler W, von Stengel S, Bebenek M, Kalender WA. Long-term exercise and risk of metabolic and cardiac diseases: the erlangen fitness and prevention study. Evid Based Complement Alternat Med. 2013;2013:768431. doi: 10.1155/2013/768431. Epub 2013 Jul 30.

  PMID: 23983804 DERIVED

Related Links

• homepage Institute of Medical Physics University of Erlangen-Nürnberg

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Motor Activity; Fractures, Bone

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Willi A Kalender, PHD, MD

  University of Erlangen-Nürnberg Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Wolfgang Kemmler

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: October 1, 1998
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

DE (1)