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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
  Purpose

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.


Condition Intervention Phase
Atrophy
 Behavioral: physical exercise, wellness
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Enrollment: 246
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267839

Locations
Germany
Institute of Medical Physics
Erlangen, Germany, 91052
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg
Behinderten und Versehrten-Sportverband Bayern
Netzwerk Knochengesundheit e.V.
Kassenärztliche Vereinigung Bayern
Siemens-Betriebskrankenkasse
Investigators
Study Chair: Willi A Kalender, PhD University of Erlangen-Nürnberg Medical School
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Institute of Medical Physics, University of Erlangen-Nurnberg
ClinicalTrials.gov Identifier: NCT00267839     History of Changes
Other Study ID Numbers: D-ER-OFZ-200501
Study First Received: December 20, 2005
Last Updated: April 21, 2008
Health Authority: Germany: Bayrisches Staatsministerium für Wissenschaft, Forschung und Kunst

Keywords provided by University of Erlangen-Nürnberg Medical School:
exercise
intervention
elderly woman
risk factors
health costs
 Osteoporosis
cardiovascular diseases
diabetes
Higher Age

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013