Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the feasibility immediately long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

Detailed Description
-----------------
This study is based on the guideline of falls management exercise programs (FaME) designed exercise from Skelton and Dinan. The FAME program is structured so that four biocybernetic pillars are embedded in the three successive stages of training. The biocybernetic pillars: improving the balance improvement in functional capacity improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety). The training phase should reach the following goals: Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity. Training Gain: with the aim to improve functional abilities. Maintaining the Gains: with the goal of muscle mass and bone density and introduce them to build complex multi-sensory exercises. We started the FaME program with assistance from the pilot study, Effects of stochastic resonance therapy on postural control in the elderly population (KEK Bern: No.228/09, Trial Registry: NCT01045746). It was found that a whole-body vibration with stochastic resonance (SR-WBV) enables that strength, coordination, and balance training while standing, in the exercise training gain phase is possible. For this reason, this study will examine the feasibility and the immediately and long term effects of SR-WBV with 6 Hz, Noise 4 on postural control and strength in frail elderly.

Official Title
-----------------
Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control: a Pilot Study

Conditions
-----------------
Equilibration Disorder, Vestibular Nerve

Intervention / Treatment
-----------------
* Device: Stochastic resonance whole-body vibration A
* Device: Stochastic resonance whole-body vibration B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RAI (Resident Assessment Instrument) >0 live in canton Bern in terms of training load be resistant. Exclusion Criteria: acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute surgical scars seniors with prosthesis. alcoholic acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb acute inflammation or infection tumors fresh surgical wounds severe migraine epilepsy acute severe pain

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1: immediate effects: T0, Stochastic resonance whole-body vibration A intervention, immediate T1 (one minute after Stochastic resonance whole-body vibration B intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration intervention, immediate T3 (one minute after Stochastic resonance whole-body vibration intervention) long term effect: T4, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T5, 16 days wash-out period; T6, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T7 | Device: Stochastic resonance whole-body vibration A<br>* Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1. Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.<br>* Other names: SRT Zeptor® med plus Noise;Device: Stochastic resonance whole-body vibration B<br>* Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4. Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.<br>* Other names: SRT Zeptor® med plus Noise;|
| Experimental: Group 2<br>Group 2: immediate effect: T0, Stochastic resonance whole-body vibration B intervention, immediate T1 (one minute after intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration A intervention, immediate T3 (one minute after intervention) Long term effect: T4, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T7 | Device: Stochastic resonance whole-body vibration A<br>* Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1. Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.<br>* Other names: SRT Zeptor® med plus Noise;Device: Stochastic resonance whole-body vibration B<br>* Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4. Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.<br>* Other names: SRT Zeptor® med plus Noise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic body balance | The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times. | effects after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static body balance | Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured. | immediate effects following one minute after a session of SR-WBV | 
| static body balance | Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured. | effects after 4 weeks | 
| dynamic body balance | The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times. | immediate effects following one minute after a session of SR-WBV | 
| dynamic body balance | The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times | effects after 4 weeks | 
| Lower extremity performance | Short physical performance battery (SPBB):The SPPB combines the results of balance tests (semi-tandem stand, side-by-side stand,full tandem stand), gait speed, and chair rise tests. | immediate effects following one minute after a session of SR-WBV | 
| Lower extermity performance | Short physical performance battery (SPBB):The SPPB combines the results of balance tests (semi-tandem stand, side-by-side stand,full tandem stand), gait speed, and chair rise tests. | effects after 4 weeks | 
| strength | Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV). | immediate effects following one minute after a session of SR-WBV | 
| strength | Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV). | effects after 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postural balance, strength