NCT01759680

Brief Summary

Tiredness, lack of motivation and low compliance can be observed in nursing home residents during the practice of physical activity. Because exercises should not be too vigorous, whole body vibration could potentially be an effective alternative. The objective of this randomized controlled trial is to assess the impact of 3-month training by whole body vibration on the risk of falls among nursing home residents. Patients were randomized into two groups: the whole body vibration group which received 3 training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz intensity and a control group with normal daily life for the whole study period. The impact of this training on the risk of falls was assessed blindly by three tests: the Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk performed with a tri-axial accelerometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

December 21, 2012

Last Update Submit

January 2, 2013

Conditions

Falls

Keywords

Risk of fallsWhole Body VibrationNursing Home

Outcome Measures

Primary Outcomes (1)

  • Risk of fall

    Tinetti test \< 19 points = high risk of falls

    3 months

Secondary Outcomes (2)

  • Risk of fall evaluated by the Timed up and Go test

    3 months

  • Risk of falls evaluated by the Locometrix

    3 months

Study Arms (2)

Whole Body Vibration Group

EXPERIMENTAL

The whole body vibration group received 3 training sessions every week composed of 5 series of 15 seconds of vibrations at 30 Hz intensity.

Device: Vibrosphère device

Control Group

NO INTERVENTION

The control group had a normal daily life for the whole study period

Interventions

Vibrosphère deviceDEVICE

Vertical Sinusoidal vibration

Also known as: Whole Body Vibration
Whole Body Vibration Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of nursing home
  • Able to move

You may not qualify if:

  • weighing more than 150 kg
  • having electronic implants (e.g. pacemaker, brain stimulators)
  • having prosthetic hips or knees
  • suffering from epilepsy, bleeding disorders, inflammatory abdominal disorders or at high risk of thromboembolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liège

Liège, Liège, 4000, Belgium

Location

Related Publications (1)

  • Beaudart C, Maquet D, Mannarino M, Buckinx F, Demonceau M, Crielaard JM, Reginster JY, Bruyere O. Effects of 3 months of short sessions of controlled whole body vibrations on the risk of falls among nursing home residents. BMC Geriatr. 2013 May 6;13:42. doi: 10.1186/1471-2318-13-42.

    PMID: 23647914DERIVED

Study Officials

  • Olivier Bruyère, PhD

    University Of Liège, Department of Public Health, Epidemiology and Health Economics, Liège, Belgiulm

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 3, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

BE(1)