Effect of Exercise on Risk-factors of Elderly Women

Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267839
• Other study ID #: D-ER-OFZ-200501
• Status: Terminated
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: May 29, 2015
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bayrisches Staatsministerium für Wissenschaft, Forschung und Kunst
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 246
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrophy

Intervention

Behavioral:
• physical exercise, wellness

Locations

Country	Name	City	State
Germany	Institute of Medical Physics	Erlangen
Germany	Institute of Medical Physics University of Erlangen-Nurnberg	Erlangen

Sponsors (5)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Behinderten- und Versehrten-Sportverband Bayern e.V., Kassenärztliche Vereinigung Bayern, Netzwerk Knochengesundheit e.V., Siemens-Betriebskrankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kemmler W, von Stengel S, Weineck J, Lauber D, Kalender W, Engelke K. Exercise effects on menopausal risk factors of early postmenopausal women: 3-yr Erlangen fitness osteoporosis prevention study results. Med Sci Sports Exerc. 2005 Feb;37(2):194-203. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health costs after 18 months		baseline 18 month control
Primary	falls after 18 months		daily records, analysis after 18 months
Primary	Bone parameters after 6, 12 and 18 months		baseline, 6, 12, 18 month-control
Secondary	Functional status after 6, 12, and 18 months
Secondary	CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
Secondary	Quality of live after 12 and 18 months

External Links

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