The Erlangen Fitness and Prevention Study (EFOPS).

NCT ID: NCT01177761

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis Osteopenia Early Postmenopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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exercise

endurance,balance, power, resistance type exercise

Group Type ACTIVE_COMPARATOR

physical exercise

Intervention Type PROCEDURE

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

sedentary control

Subjects were instructed to do not relevantly change their lifestyle

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical exercise

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Behinderten- und Versehrten-Sportverband Bayern e.V.

OTHER

Sponsor Role collaborator

Netzwerk Knochengesundheit e.V.

UNKNOWN

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Kemmler

Professor Dr. Wolfgang Kemmler

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Willi A Kalender, PHD, MD

Role: STUDY_CHAIR

University of Erlangen-Nürnberg Medical School

Locations

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Institute of Medical Physics, University of Erlangen-Nurnberg

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21625881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23190199 (View on PubMed)

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.

Reference Type RESULT
PMID: 16096715 (View on PubMed)

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.

Reference Type RESULT
PMID: 17313298 (View on PubMed)

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.

Reference Type RESULT
PMID: 15746294 (View on PubMed)

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.

Reference Type RESULT
PMID: 15159265 (View on PubMed)

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.

Reference Type RESULT
PMID: 14504954 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23983804 (View on PubMed)

Related Links

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http://www.imp.uni-erlangen.de/

homepage Institute of Medical Physics University of Erlangen-Nürnberg

Other Identifiers

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OFZ-EFOPS

Identifier Type: -

Identifier Source: org_study_id