Whole-body Vibration Training in Older People (GERIAPLAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01375790|
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : August 29, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Aging||Device: Exercise with Whole-body vibration platform Other: Exercise||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||March 2012|
Experimental: Exercise with Whole-body vibration platform
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.
Device: Exercise with 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).
Other Name: Power Plate® Whole-body vibration platform
Active Comparator: Exercise
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
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.
Other Name: Balance and resistance training
- Body balance. [ Time Frame: at 6 weeks ]Body balance will be evaluated using Tinetti Test, and Timed up and go test
- Body balance [ Time Frame: at six months ]Body balance will be evaluated using Tinetti Test, and Timed up and go test
- Muscle performance [ Time Frame: at 6 weeks, and 6 months ]It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.
- Number of falls [ Time Frame: during 6 months ]Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.
- Safety of interventions [ Time Frame: During 6 months ]Pain, headache, itching or soreness on the legs, erythema.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375790
|Albada Centre Socio Sanitari Parc Taulí|
|Sabadell, Babadell, Spain, 08208|
|Badalona, Barcelona, Spain, 08911|
|Barberà del Vallès, Barcelona, Spain, 08210|
|Sabadell, Barcelona, Spain, 08203|
|Residència Poble Nou|
|Barcelona, Spain, 08005|
|Ballesol Fabra i Puig|
|Barcelona, Spain, 08016|
|Barcelona, Spain, 08018|
|Residència Mapfre Quavitae|
|Barcelona, Spain, 08025|
|Residència AMMA Horta|
|Barcelona, Spain, 08035|
|Residència Collserola (Mutuam)|
|Barcelona, Spain, 08035|
|Principal Investigator:||Mercè Sitjà Rabert, PhD||• Health Sciences Faculty Blanquerna (Universitat Ramon Llull)|