Effect of Exercise on Risk-factors of Elderly Women

NCT ID: NCT00267839

Last Updated: 2015-06-01

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.

Detailed Description

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The human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. Osteoporosis, diabetes type II and arteriosclerosis are diseases known to correlate with age. Participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". Unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. However, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. Furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of Germany. We hypothesize that regular exercise

1. significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
2. significantly reduces health costs in elderly community living women

Conditions

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Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Interventions

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physical exercise, wellness

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

Exclusion Criteria

* secondary osteoporosis
* CVD-events including stroke
* Participation in other studies
* Medication with impact on bone during the last 2 years:

* bisphosphonates
* parathormone
* strontium
* HRT, anabolic steroids
* calcitonin
* natriumflourides
* active Vit-D-metabolites
* cortisone \> 5 mg/d
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Behinderten- und Versehrten-Sportverband Bayern e.V.

OTHER

Sponsor Role collaborator

Netzwerk Knochengesundheit e.V.

UNKNOWN

Sponsor Role collaborator

Kassenärztliche Vereinigung Bayern

UNKNOWN

Sponsor Role collaborator

Siemens-Betriebskrankenkasse

INDUSTRY

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Willi A Kalender, PhD

Role: STUDY_CHAIR

University of Erlangen-Nürnberg Medical School

Locations

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Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, , Germany

Site Status

Institute of Medical Physics

Erlangen, , Germany

Site Status

Countries

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Germany

References

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Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. doi: 10.1249/01.mss.0000152678.20239.76.

Reference Type BACKGROUND
PMID: 15692313 (View on PubMed)

Kemmler W, von Stengel S, Engelke K, Haberle L, Mayhew JL, Kalender WA. Exercise, body composition, and functional ability: a randomized controlled trial. Am J Prev Med. 2010 Mar;38(3):279-87. doi: 10.1016/j.amepre.2009.10.042.

Reference Type DERIVED
PMID: 20171529 (View on PubMed)

Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.

Reference Type DERIVED
PMID: 20101013 (View on PubMed)

Related Links

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Other Identifiers

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D-ER-OFZ-200501

Identifier Type: -

Identifier Source: org_study_id

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