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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

December 20, 2005
April 21, 2008
January 2006
November 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • - health costs after 18 months
  • - falls after 18 months
  • - BMD after 12 and 18 months
Complete list of historical versions of study NCT00267839 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Exercise on Risk-Factors of Elderly Women
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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Atrophy
Behavioral: physical exercise, wellness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
March 2008
November 2007   (final data collection date for primary outcome measure)

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
Female
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00267839
D-ER-OFZ-200501
Not Provided
Institute of Medical Physics, University of Erlangen-Nurnberg
University of Erlangen-Nürnberg
  • Behinderten und Versehrten-Sportverband Bayern
  • Netzwerk Knochengesundheit e.V.
  • Kassenärztliche Vereinigung Bayern
  • Siemens-Betriebskrankenkasse
Study Chair: Willi A Kalender, PhD University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
April 2008

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