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

Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759680
• Other study ID #: SPEES/CB/WBV01
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: January 2, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: December 2012
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falls

Intervention

Device:
• Vibrosphère device
Vertical Sinusoidal vibration

Locations

Country	Name	City	State
Belgium	University of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of fall	Tinetti test < 19 points = high risk of falls	3 months	Yes
Secondary	Risk of fall evaluated by the Timed up and Go test	A timed Up and Go > 14 seconds = high risk of falls	3 months	Yes
Secondary	Risk of falls evaluated by the Locometrix	Locometrix is a walking test	3 months	Yes