NCT00267839

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

December 20, 2005

Last Update Submit

May 29, 2015

Conditions

Atrophy

Keywords

exerciseinterventionelderly womanrisk factorshealth costsOsteoporosiscardiovascular diseasesdiabetesHigher Age

Outcome Measures

Primary Outcomes (3)

  • health costs after 18 months

    baseline 18 month control

  • falls after 18 months

    daily records, analysis after 18 months

  • Bone parameters after 6, 12 and 18 months

    baseline, 6, 12, 18 month-control

Secondary Outcomes (3)

  • 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

Interventions

physical exercise, wellnessBEHAVIORAL

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

Institute of Medical Physics

Erlangen, 91052, Germany

Location

Related Publications (3)

  • 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.

    PMID: 15692313BACKGROUND

  • 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.

    PMID: 20171529DERIVED

  • 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.

    PMID: 20101013DERIVED

Related Links

MeSH Terms

Conditions

AtrophyMotor ActivityOsteoporosisCardiovascular DiseasesDiabetes Mellitus

Interventions

ExerciseHealth

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehaviorBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPopulation Characteristics

Study Officials

  • Willi A Kalender, PhD

    University of Erlangen-Nürnberg Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

DE(2)