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Effect of Exercise on Risk-factors of Elderly Women

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ClinicalTrials.gov Identifier: NCT00267839
Recruitment Status : Terminated
First Posted : December 21, 2005
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrophy Behavioral: physical exercise, wellness Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : January 2006
Primary Completion Date : November 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. health costs after 18 months [ Time Frame: baseline 18 month control ]
  2. falls after 18 months [ Time Frame: daily records, analysis after 18 months ]
  3. Bone parameters after 6, 12 and 18 months [ Time Frame: baseline, 6, 12, 18 month-control ]

Secondary Outcome Measures :
  1. Functional status after 6, 12, and 18 months
  2. CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
  3. Quality of live after 12 and 18 months

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267839

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00267839     History of Changes
Other Study ID Numbers: D-ER-OFZ-200501
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Pathological Conditions, Anatomical