Clinical trial NCT00267839: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrophy
Keywords: exercise
intervention
elderly woman
risk factors
health costs
Osteoporosis
cardiovascular diseases
diabetes
Higher Age
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Behinderten- und Versehrten-Sportverband Bayern e.V.
name: Netzwerk Knochengesundheit e.V.
name: Kassenärztliche Vereinigung Bayern
name: Siemens-Betriebskrankenkasse
First posted: 2005-12-21
Enrollment: 246
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: health costs after 18 months
timeFrame: baseline 18 month control
measure: falls after 18 months
timeFrame: daily records, analysis after 18 months
measure: Bone parameters after 6, 12 and 18 months
timeFrame: baseline, 6, 12, 18 month-control
Secondary outcomes:
measure: Functional status after 6, 12, and 18 months
measure: CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months
measure: Quality of live after 12 and 18 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics University of Erlangen-Nurnberg
city: Erlangen
country: Germany
facility: Institute of Medical Physics
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Willi A Kalender, PhD
role: STUDY_CHAIR
References:
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.
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.
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.