Effect of Whole Body Vibration on Bone and Fall Related P... | NCT00292916

Studies
Effect of Whole Body Vibration on Bone and Fall Related Parameters

NCT00292916

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Terminated

Last Update Posted

May 28, 2015Estimated

Enrollment

150

Phase

Phase 3

Conditions

Atrophy

Interventions

whole body vibration
resistance exercise
"wellness"

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Feb 15, 2006

First Submission Date that Met QC Criteria

Feb 15, 2006

First Posted Date

Feb 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Name	Class
Institute of Biometrie and Medical Statistics	UNKNOWN
Netzwerk-Knochengesundheit	UNKNOWN
Siemens-Betriebskrankenkasse	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Willi A Kalender, PhD	University of Erlangen-Nürnberg Medical School	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Medical Physics		Erlangen		91052	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16307280	Background	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.
16096715	Background	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.

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Name	Type	Description	Arm Group Labels	Other Names
whole body vibration	Behavioral
resistance exercise	Behavioral
"wellness"	Behavioral

Measure	Description	Time Frame
BMD after 6, 12 and 18 months
strength
power

Measure	Description	Time Frame
balance
bone markers

ID	Term
D001284	Atrophy
D009043	Motor Activity

ID	Term
D055070	Resistance Training
D006262	Health