SR-WBV Training for Frail Elderly in the Skilling up Stage

Study Overview
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Brief Summary
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This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.

Detailed Description
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This study is based on the guideline of falls management exercise programs (FaME; from Skelton and Dinan). The goals: Skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity. Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth, improvement of bone density and multi-sensory exercises. First, a pilot study was conducted with untrained elderly (Effects of stochastic resonance therapy on postural control in the elderly population (KEK Bern: No.228/09, Clinical Trial Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control Clinical Trial Registry:NCT01543243). It was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. But for frail elderly the chosen form of recruitment and the measurement methods are not sufficient. For this study, measurement parameters for functional performance and strength will be used. Goals of the study in the skilling up phase: Feasibility Study the effect on physical functional performance Study the effects on muscle strength. The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.

Official Title
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Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

Conditions
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Poor Performance Status, Muscle Weakness

Intervention / Treatment
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* Device: SR-WBV
* Device: SR-WBV


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Intervention<br>T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1 | Device: SR-WBV<br>* Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.<br>* Other names: Intervention-Group;|
| Sham Comparator: Sham group<br>T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1 | Device: SR-WBV<br>* Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.<br>* Other names: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Functional Performance | Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living. The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is Poor performance; SPPB 7-9 is Intermediate performance; SPPB 10-12 is High Performance. | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor | It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. | after 4 weeks | 
| Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension | It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. | after 4 weeks | 
| Isometric Rate of Force Development (IRFD) Right Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | after 4 weeks | 
| Isometric Rate of Force Development (IRFD) Left Knee-extensor | It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. | after 4 weeks |