NCT00292916

Brief Summary

The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

First QC Date

February 15, 2006

Last Update Submit

May 27, 2015

Conditions

Atrophy

Keywords

whole body vibrationexerciseelderly womanBone Mineral Densityfallshigher age

Outcome Measures

Primary Outcomes (3)

  • BMD after 6, 12 and 18 months

  • strength

  • power

Secondary Outcomes (2)

  • balance

  • bone markers

Interventions

whole body vibrationBEHAVIORAL
resistance exerciseBEHAVIORAL
"wellness"BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • community living elderly females \>/=65 years
  • live expectation \> 2 years

You may not qualify if:

  • secondary osteoporosis
  • CVD-events including stroke
  • participation in other studies
  • medication and illness affecting bone metabolism within the last 2 years
  • 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 (1)

Institute of Medical Physics

Erlangen, 91052, Germany

Location

Related Publications (5)

  • Kemmler W, Engelke K, Baumann H, Beeskow C, von Stengel S, Weineck J, Kalender WA. Bone status in elite male runners. Eur J Appl Physiol. 2006 Jan;96(1):78-85. doi: 10.1007/s00421-005-0060-1. Epub 2005 Oct 26.

    PMID: 16307280BACKGROUND

  • Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.

    PMID: 16096715BACKGROUND

  • Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.

    PMID: 15746294BACKGROUND

  • Kemmler W, Weineck J, Kalender WA, Engelke K. The effect of habitual physical activity, non-athletic exercise, muscle strength, and VO2max on bone mineral density is rather low in early postmenopausal osteopenic women. J Musculoskelet Neuronal Interact. 2004 Sep;4(3):325-34.

    PMID: 15615501BACKGROUND

  • Von Stengel S, Kemmler W, Bebenek M, Engelke K, Kalender WA. Effects of whole-body vibration training on different devices on bone mineral density. Med Sci Sports Exerc. 2011 Jun;43(6):1071-9. doi: 10.1249/MSS.0b013e318202f3d3.

    PMID: 20980923DERIVED

MeSH Terms

Conditions

AtrophyMotor Activity

Interventions

Resistance TrainingHealth

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor 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
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

January 1, 2006

Study Completion

July 1, 2007

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DE(1)