Effect of Exercise on Risk-Factors of Elderly Women

This study has been completed.

Sponsor:

Collaborators:

Behinderten und Versehrten-Sportverband Bayern

Netzwerk Knochengesundheit e.V.

Kassenärztliche Vereinigung Bayern

Siemens-Betriebskrankenkasse

Information provided by:

University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT00267839

First received: December 20, 2005

Last updated: April 21, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2005

Last Updated Date

April 21, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

health costs after 18 months [ Time Frame: baseline 18 month control ]
falls after 18 months [ Time Frame: daily records, analysis after 18 months ]
Bone parameters after 6, 12 and 18 months [ Time Frame: baseline, 6, 12, 18 month-control ]

Original Primary Outcome Measures ^ICMJE

- health costs after 18 months
- falls after 18 months
- BMD after 12 and 18 months

Change History

Complete list of historical versions of study NCT00267839 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional status after 6, 12, and 18 months
CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
Quality of live after 12 and 18 months

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Exercise on Risk-Factors of Elderly Women

Official Title ^ICMJE

Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)

Brief Summary

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

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Atrophy

Intervention ^ICMJE

Behavioral: physical exercise, wellness

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

246

Completion Date

March 2008

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00267839

Other Study ID Numbers ^ICMJE

D-ER-OFZ-200501

Has Data Monitoring Committee

Not Provided

Responsible Party

Institute of Medical Physics, University of Erlangen-Nurnberg

Study Sponsor ^ICMJE

University of Erlangen-Nürnberg

Collaborators ^ICMJE

Behinderten und Versehrten-Sportverband Bayern
Netzwerk Knochengesundheit e.V.
Kassenärztliche Vereinigung Bayern
Siemens-Betriebskrankenkasse

Investigators ^ICMJE

Study Chair:

Willi A Kalender, PhD

University of Erlangen-Nürnberg Medical School

Information Provided By

University of Erlangen-Nürnberg Medical School

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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