- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01759680
Effects of 3 Months of Controlled Whole Body Vibrations on the Risk of Falls Among Nursing Home Residents
Effects of 3 Months of Controlled Whole Body Vibrations With Low Exposure Period on the Risk of Falls Among Nursing Home Residents
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Liège, Belgium, 4000
- University of Liege
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Vertical Sinusoidal vibration
Other Names:
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No Intervention: Control Group
The control group had a normal daily life for the whole study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of fall
Time Frame: 3 months
|
Tinetti test < 19 points = high risk of falls
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of fall evaluated by the Timed up and Go test
Time Frame: 3 months
|
A timed Up and Go > 14 seconds = high risk of falls
|
3 months
|
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Risk of falls evaluated by the Locometrix
Time Frame: 3 months
|
Locometrix is a walking test
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Olivier Bruyère, PhD, University Of Liège, Department of Public Health, Epidemiology and Health Economics, Liège, Belgiulm
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPEES/CB/WBV01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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