Effects of 3 Months of Controlled Whole Body Vibrations on the Risk of Falls Among Nursing Home Residents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charlotte Beaudart, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT01759680
First received: December 21, 2012
Last updated: January 2, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Falls
Device: Vibrosphère device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of 3 Months of Controlled Whole Body Vibrations With Low Exposure Period on the Risk of Falls Among Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Risk of fall [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Tinetti test < 19 points = high risk of falls


Secondary Outcome Measures:
  • Risk of fall evaluated by the Timed up and Go test [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A timed Up and Go > 14 seconds = high risk of falls

  • Risk of falls evaluated by the Locometrix [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Locometrix is a walking test


Enrollment: 62
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole Body Vibration Group
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
Vertical Sinusoidal vibration
Other Name: Whole Body Vibration
No Intervention: Control Group
The control group had a normal daily life for the whole study period

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of nursing home
  • Able to move

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759680

Locations
Belgium
University of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege
Investigators
Study Director: Olivier Bruyère, PhD University Of Liège, Department of Public Health, Epidemiology and Health Economics, Liège, Belgiulm
  More Information

No publications provided by University Hospital of Liege

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Beaudart, PhD Student, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT01759680     History of Changes
Other Study ID Numbers: SPEES/CB/WBV01
Study First Received: December 21, 2012
Last Updated: January 2, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital of Liege:
Risk of falls
Whole Body Vibration
Nursing Home

ClinicalTrials.gov processed this record on September 22, 2014