Effect of Exercise on Risk-factors of Elderly Women

Phase 3

Terminated

• Conditions: Atrophy

• Registration Number: NCT00267839
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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

Study Timeline

• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-21
• Study Start: 2006-01
• Primary Completion: 2007-11
• Study Completion: 2008-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 246

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
falls after 18 months	daily records, analysis after 18 months
Bone parameters after 6, 12 and 18 months	baseline, 6, 12, 18 month-control
health costs after 18 months	baseline 18 month control

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Institute of Medical Physics University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany

Institute of Medical Physics; 🇩🇪 Erlangen, Germany