FallsNCT01759680
Effects of 3 Months of Controlled Whole Body Vibrations on the Risk of Falls Among Nursing Home Residents
A study testing Vibrosphère device in people with Falls, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Vibrosphère device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident of nursing home
- Able to move
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Falls
- Being tested
- Vibrosphère device
- Keywords
- Risk of falls, Whole Body Vibration, Nursing Home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrosphère deviceDevice
Also called Whole Body Vibration
Vertical Sinusoidal vibration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vibrosphère device |
| Control Group | No intervention | The control group had a normal daily life for the whole study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of fall
Tinetti test < 19 points = high risk of falls
Measured: 3 months
Secondary outcomes (2)
Risk of fall evaluated by the Timed up and Go test
A timed Up and Go > 14 seconds = high risk of falls
Measured: 3 months
Risk of falls evaluated by the Locometrix
Locometrix is a walking test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Beaudart, University of Liege
- Investigators
- Olivier Bruyère, PhD, Study director, University Of Liège, Department of Public Health, Epidemiology and Health Economics, Liège, Belgiulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759680
- Sponsor's protocol ID
- SPEES/CB/WBV01
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23647914
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3 Months of Controlled Whole Body Vibrations With Low Exposure Period on the Risk of Falls Among Nursing Home Residents
- ClinicalTrials.gov ID
- NCT01759680
- Acronym / sponsor ID
- SPEES/CB/WBV01
- Conditions
- Falls
- Keywords
- Risk of falls, Whole Body Vibration, Nursing Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration Group | Experimental | Device: Vibrosphère deviceThe whole body vibration group received 3 training sessions every week composed of 5 series of 15 seconds of vibrations at 30 Hz intensity. |
| Control Group | No intervention | –The control group had a normal daily life for the whole study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Resident of nursing home
- Able to move
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrosphère deviceAlso: Whole Body VibrationVertical Sinusoidal vibration | Device | Whole Body Vibration Group |
Primary outcome
Risk of fall
Time frame: 3 months
Tinetti test < 19 points = high risk of falls
2 secondary outcomes
Risk of fall evaluated by the Timed up and Go test
Time frame: 3 months
Risk of falls evaluated by the Locometrix
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Derived from this study: PubMed 23647914Beaudart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Bruyère, PhD study director
University Of Liège, Department of Public Health, Epidemiology and Health Economics, Liège, Belgiulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrosphère device in people with Falls, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of fall (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.