Effect of Exercise on Risk-factors of Elderly Women

May 29, 2015 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

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

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Institute of Medical Physics University of Erlangen-Nurnberg
      • Erlangen, Germany, 91052
        • Institute of medical physics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

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

Investigators

  • Study Chair: Willi A Kalender, PhD, University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-ER-OFZ-200501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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