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The Erlangen Fitness and Prevention Study (EFOPS). (EFOPS)

Primary Purpose

Osteoporosis, Osteopenia, Early Postmenopause

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
physical exercise
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, exercise, fractures, Bone Mineral Density, CHD-risk

Eligibility Criteria

48 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Medical Physics, University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

exercise

sedentary control

Arm Description

endurance,balance, power, resistance type exercise

Subjects were instructed to do not relevantly change their lifestyle

Outcomes

Primary Outcome Measures

overall-fractures (low-trauma)
As assessed by questionnaire and structured interview
Bone Mineral Density at Lumbar Spine and Proximal Femur
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)

Secondary Outcome Measures

10-year coronary heart disease (CHD) risk
As assessed by Framingham Risk Factor Calculator according to Wilson.
Metabolic Syndrome Z-Score
Metabolic Syndrome Z-Score Index according to Johnson

Full Information

First Posted
August 6, 2010
Last Updated
November 2, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01177761
Brief Title
The Erlangen Fitness and Prevention Study (EFOPS).
Acronym
EFOPS
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1998 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia, Early Postmenopause
Keywords
Osteoporosis, exercise, fractures, Bone Mineral Density, CHD-risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Active Comparator
Arm Description
endurance,balance, power, resistance type exercise
Arm Title
sedentary control
Arm Type
No Intervention
Arm Description
Subjects were instructed to do not relevantly change their lifestyle
Intervention Type
Procedure
Intervention Name(s)
physical exercise
Intervention Description
Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
Primary Outcome Measure Information:
Title
overall-fractures (low-trauma)
Description
As assessed by questionnaire and structured interview
Time Frame
16 year follow-up
Title
Bone Mineral Density at Lumbar Spine and Proximal Femur
Description
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
Time Frame
16 year follow-up
Secondary Outcome Measure Information:
Title
10-year coronary heart disease (CHD) risk
Description
As assessed by Framingham Risk Factor Calculator according to Wilson.
Time Frame
16 year follow-up
Title
Metabolic Syndrome Z-Score
Description
Metabolic Syndrome Z-Score Index according to Johnson
Time Frame
16 year follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willi A Kalender, PHD, MD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Physics, University of Erlangen-Nurnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21625881
Citation
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.
Results Reference
background
PubMed Identifier
23190199
Citation
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.
Results Reference
background
PubMed Identifier
16096715
Citation
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.
Results Reference
result
PubMed Identifier
17313298
Citation
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.
Results Reference
result
PubMed Identifier
15746294
Citation
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.
Results Reference
result
PubMed Identifier
15159265
Citation
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.
Results Reference
result
PubMed Identifier
14504954
Citation
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.
Results Reference
result
PubMed Identifier
23983804
Citation
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.
Results Reference
derived
Links:
URL
http://www.imp.uni-erlangen.de/
Description
homepage Institute of Medical Physics University of Erlangen-Nürnberg

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The Erlangen Fitness and Prevention Study (EFOPS).

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