Effect of Exercise on Risk-factors of Elderly Women
Primary Purpose
Atrophy
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
physical exercise, wellness
Sponsored by
About this trial
This is an interventional prevention trial for Atrophy focused on measuring exercise, intervention, elderly woman, risk factors, health costs, Osteoporosis, cardiovascular diseases, diabetes, Higher Age
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 active Vit-D-metabolites cortisone > 5 mg/d medication with impact on falls low physical performance (<50 Watt during ergometry) excessive alcohol-intake
Sites / Locations
- Institute of Medical Physics University of Erlangen-Nurnberg
- Institute of Medical Physics
Outcomes
Primary Outcome Measures
health costs after 18 months
falls after 18 months
Bone parameters after 6, 12 and 18 months
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00267839
First Posted
December 20, 2005
Last Updated
May 29, 2015
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V., Kassenärztliche Vereinigung Bayern, Siemens-Betriebskrankenkasse
1. Study Identification
Unique Protocol Identification Number
NCT00267839
Brief Title
Effect of Exercise on Risk-factors of Elderly Women
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Behinderten- und Versehrten-Sportverband Bayern e.V., Netzwerk Knochengesundheit e.V., Kassenärztliche Vereinigung Bayern, Siemens-Betriebskrankenkasse
4. Oversight
5. 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.
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
significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
significantly reduces health costs in elderly community living women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy
Keywords
exercise, intervention, elderly woman, risk factors, health costs, Osteoporosis, cardiovascular diseases, diabetes, Higher Age
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
physical exercise, wellness
Primary Outcome Measure Information:
Title
health costs after 18 months
Time Frame
baseline 18 month control
Title
falls after 18 months
Time Frame
daily records, analysis after 18 months
Title
Bone parameters after 6, 12 and 18 months
Time Frame
baseline, 6, 12, 18 month-control
Secondary Outcome Measure Information:
Title
Functional status after 6, 12, and 18 months
Title
CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
Title
Quality of live after 12 and 18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
active Vit-D-metabolites
cortisone > 5 mg/d
medication with impact on falls
low physical performance (<50 Watt during ergometry)
excessive alcohol-intake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willi A Kalender, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Medical Physics University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Institute of Medical Physics
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15692313
Citation
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. doi: 10.1249/01.mss.0000152678.20239.76.
Results Reference
background
PubMed Identifier
20171529
Citation
Kemmler W, von Stengel S, Engelke K, Haberle L, Mayhew JL, Kalender WA. Exercise, body composition, and functional ability: a randomized controlled trial. Am J Prev Med. 2010 Mar;38(3):279-87. doi: 10.1016/j.amepre.2009.10.042.
Results Reference
derived
PubMed Identifier
20101013
Citation
Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
Results Reference
derived
Links:
URL
http://www.imp.uni-erlangen.de
Description
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Effect of Exercise on Risk-factors of Elderly Women
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