AgingPhase 3GERIAPLATNCT01375790
Whole-body Vibration Training in Older People
A Phase 3 study testing Exercise with Whole-body vibration platform and Exercise in people with Aging, run by Asociacion Colaboracion Cochrane Iberoamericana at 10 sites in Spain.
Trial summary
This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator. The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Exercise with Whole-body vibration platform and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 10 sitesSpain
- Study dates
- Nov 2010to Mar 2012
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Institutionalized older people who were 65 years and older
- The patient consent to participate in the study
Who cannot join
- Residents who present an acute disease that not resolved during 10 days.
- Residents with a pacemaker (or serious cardiac alterations)
- Residents with epilepsy
- Residents with a high risk of thromboembolism
- Residents with a history of a hip or knee joint replacement
- Residents who not were musculoskeletal disorders and cognitive or physical dysfunction that interfering with test and training procedures.
- Residents that not accept to participate in the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Ballesol Badalona
Badalona, Barcelona, 08911
Ballesol Barberà
Barbera Del Valles, Barcelona, 08210
Residència Poble Nou
Barcelona, Barcelona, 08005
Ballesol Fabra i Puig
Barcelona, Barcelona, 08016
Ballesol Almogàvers
Barcelona, Barcelona, 08018
Residència Mapfre Quavitae
Barcelona, Barcelona, 08025
Residència AMMA Horta
Barcelona, Barcelona, 08035
Residència Collserola (Mutuam)
Barcelona, Barcelona, 08035
Albada Centre Socio Sanitari Parc Taulí
Sabadell, Babadell, 08208
Residència Allegra
Sabadell, Barcelona, 08203
About this study
Official title: Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator
This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.
The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).
- Conditions
- Aging
- Being tested
- Exercise with Whole-body vibration platform, Exercise
- Keywords
- whole-body vibration, older people, exercise, body balance, muscle performance, falls, physiotherapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with Whole-body vibration platformDevice
Also called Power Plate® Whole-body vibration platform
The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).
ExerciseOther
Also called Balance and resistance training
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with Whole-body vibration platform | Experimental | Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm). Training volume and intensity we will increase systematically over six weeks according to the overload principle. Receives: Device: Exercise with Whole-body vibration platform |
| Exercise | Active comparator | The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli, during a six weeks training period (3sessions/week). Training volume and intensity we will increase systematically over six weeks according to the overload principle Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body balance.
Body balance will be evaluated using Tinetti Test, and Timed up and go test
Measured: at 6 weeks
Secondary outcomes (4)
Body balance
Body balance will be evaluated using Tinetti Test, and Timed up and go test
Measured: at six months
Muscle performance
It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.
Measured: at 6 weeks, and 6 months
Number of falls
Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.
Measured: during 6 months
Safety of interventions
Pain, headache, itching or soreness on the legs, erythema.
Measured: During 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion Colaboracion Cochrane Iberoamericana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mercè Sitjà Rabert, PhD, Principal investigator, • Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375790
- Sponsor's protocol ID
- GERIAPLAT/1
- Other IDs
- PI/180-2010
- Acronym
- GERIAPLAT
- Status last verified
- Aug 2012
- First submitted
- 16 Jun 2011
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sitja-Rabert M, Martinez-Zapata MJ, Fort Vanmeerhaeghe A, Rey Abella F, Romero-Rodriguez D, Bonfill X. Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial. J Am Med Dir Assoc. 2015 Feb;16(2):125-31. doi: 10.1016/j.jamda.2014.07.018. Epub 2014 Oct 3.
PubMed 25282631Sitja-Rabert M, Martinez-Zapata MJ, Fort-Vanmeerhaeghe A, Rey-Abella F, Romero-Rodriguez D, Bonfill X. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial. BMC Geriatr. 2011 Dec 22;11:89. doi: 10.1186/1471-2318-11-89.
PubMed 22192313
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator
- ClinicalTrials.gov ID
- NCT01375790
- Acronym / sponsor ID
- GERIAPLAT / GERIAPLAT/1
- Conditions
- Aging
- Keywords
- whole-body vibration, older people, exercise, body balance, muscle performance, falls, physiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Asociacion Colaboracion Cochrane IberoamericanaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Jun 2011 (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.
This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.
The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with Whole-body vibration platform | Experimental | Device: Exercise with Whole-body vibration platformExercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm). Training volume and intensity we will increase systematically over six weeks according to the overload principle. |
| Exercise | Active comparator | Other: ExerciseThe participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli, during a six weeks training period (3sessions/week). Training volume and intensity we will increase systematically over six weeks according to the overload principle |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Institutionalized older people who were 65 years and older
- The patient consent to participate in the study
Key exclusion criteria (7 listed)
- Residents who present an acute disease that not resolved during 10 days.
- Residents with a pacemaker (or serious cardiac alterations)
- Residents with epilepsy
- Residents with a high risk of thromboembolism
- Residents with a history of a hip or knee joint replacement
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 |
|---|---|---|
| Exercise with Whole-body vibration platformAlso: Power Plate® Whole-body vibration platformThe participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm). | Device | Exercise with Whole-body vibration platform |
| ExerciseAlso: Balance and resistance trainingThe participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli. | Other | Exercise |
Primary outcome
Body balance.
Time frame: at 6 weeks
Body balance will be evaluated using Tinetti Test, and Timed up and go test
4 secondary outcomes
Body balance
Time frame: at six months
Muscle performance
Time frame: at 6 weeks, and 6 months
Number of falls
Time frame: during 6 months
Safety of interventions
Time frame: During 6 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 29 Aug 2012.
- Derived from this study: PubMed 25282631Sitja-Rabert M, Martinez-Zapata MJ, Fort Vanmeerhaeghe A, Rey Abella F, Romero-Rodriguez D, Bonfill X. Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial. J Am Med Dir Assoc. 2015 Feb;16(2):125-31. doi: 10.1016/j.jamda.2014.07.018. Epub 2014 Oct 3.
- Derived from this study: PubMed 22192313Sitja-Rabert M, Martinez-Zapata MJ, Fort-Vanmeerhaeghe A, Rey-Abella F, Romero-Rodriguez D, Bonfill X. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial. BMC Geriatr. 2011 Dec 22;11:89. doi: 10.1186/1471-2318-11-89.
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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.
Mercè Sitjà Rabert, PhD principal investigator
• Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise with Whole-body vibration platform and Exercise in people with Aging, run by Asociacion Colaboracion Cochrane Iberoamericana at 10 sites in Spain.
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 7 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 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body balance. (time frame: at 6 weeks). 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 NCT01375790, which also lists 2 linked publications.
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 29 Aug 2012.