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Clinical Trials/NCT00267839
NCT00267839
Terminated
Phase 3

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

University of Erlangen-Nürnberg Medical School2 sites in 1 country246 target enrollmentJanuary 2006
ConditionsAtrophy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Atrophy
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
246
Locations
2
Primary Endpoint
falls after 18 months
Status
Terminated
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
March 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Time Frame: baseline 18 month control

Secondary Outcomes

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

Study Sites (2)

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