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

Phase 2

Completed

• Conditions: Equilibration Disorder, Vestibular Nerve
• Interventions: Device: Stochastic resonance whole-body vibration A; Device: Stochastic resonance whole-body vibration B

• Registration Number: NCT01543243
• Lead Sponsor: Bern University of Applied Sciences

Brief Summary

This study aims to examine

1. the feasibility

2. immediately

3. 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:

1. improving the balance

2. improvement in functional capacity

3. improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

1. Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.

2. Training Gain: with the aim to improve functional abilities.

3. 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.

Study Timeline

• Study First Submitted: 2011-09-26
• Study Start: 2011-11
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-11
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Stochastic resonance whole-body vibration A	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
Group 1	Stochastic resonance whole-body vibration A	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
Group 2	Stochastic resonance whole-body vibration B	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
Group 1	Stochastic resonance whole-body vibration B	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

Primary Outcome Measures

Name	Time	Method
Dynamic body balance	effects after 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Lower extremity performance	immediate effects following one minute after a session of SR-WBV	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.
Lower extermity performance	effects after 4 weeks	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.
strength	effects after 4 weeks	Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).
static body balance	effects after 4 weeks	Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured.
dynamic body balance	effects after 4 weeks	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

Trial Locations

Locations (1)

Bern University of Applied Science, Department Health; 🇨🇭 Bern, Switzerland