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

Equilibration Disorder, Vestibular Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543243
• Other study ID #: PhD pilot study 2
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2011
• Last updated: June 11, 2016
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2016
• Source: Bern University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Equilibration Disorder, Vestibular Nerve

Intervention

Device:
• Stochastic resonance whole-body vibration A
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.
• Stochastic resonance whole-body vibration B
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.

Locations

Country	Name	City	State
Switzerland	Bern University of Applied Science, Department Health	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Bern University of Applied Sciences	Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Rogan S, Radlinger L, Schmidtbleicher D, de Bie RA, de Bruin ED. Preliminary inconclusive results of a randomised double blinded cross-over pilot trial in long-term-care dwelling elderly assessing the feasibility of stochastic resonance whole-body vibrati — View Citation

Rogan S, Schmidtbleicher D, Radlinger L. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study. Aging Clin Exp Res. 2014 Oct;26(5):519 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes