Whole-body Vibration Training in Older People

Study Overview
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Brief Summary
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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).

Official Title
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Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator

Conditions
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Aging

Intervention / Treatment
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* Device: Exercise with Whole-body vibration platform
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Institutionalized older people who were 65 years and older The patient consent to participate in the study Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise with Whole-body vibration platform<br>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<br>* The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).<br>* Other names: Power Plate® Whole-body vibration platform;|
| Active Comparator: Exercise<br>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 | Other: Exercise<br>* The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.<br>* Other names: Balance and resistance training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body balance. | Body balance will be evaluated using Tinetti Test, and Timed up and go test | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body balance | Body balance will be evaluated using Tinetti Test, and Timed up and go test | at six months | 
| Muscle performance | It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder. | 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. | during 6 months | 
| Safety of interventions | Pain, headache, itching or soreness on the legs, erythema. | During 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole-body vibration, older people, exercise, body balance, muscle performance, falls, physiotherapy