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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01543243
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : June 14, 2016
Sponsor:
Collaborators:
Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Slavko Rogan, cand. PhD, PTMsc, Bern University of Applied Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Equilibration Disorder, Vestibular Nerve Device: Stochastic resonance whole-body vibration A Device: Stochastic resonance whole-body vibration B Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control: a Pilot Study
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1

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

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.

Other Name: SRT Zeptor® med plus Noise

Device: 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.

Other Name: SRT Zeptor® med plus Noise
Experimental: Group 2

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

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.

Other Name: SRT Zeptor® med plus Noise

Device: 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.

Other Name: SRT Zeptor® med plus Noise


Outcome Measures
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Primary Outcome Measures :
  1. Dynamic body balance [ Time Frame: 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 :
  1. static body balance [ Time Frame: immediate effects following one minute after a session of SR-WBV ]
    Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured.

  2. static body balance [ Time Frame: 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.

  3. dynamic body balance [ Time Frame: immediate effects following one minute after a session of SR-WBV ]
    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.

  4. dynamic body balance [ Time Frame: 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

  5. Lower extremity performance [ Time Frame: 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.

  6. Lower extermity performance [ Time Frame: 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.

  7. strength [ Time Frame: immediate effects following one minute after a session of SR-WBV ]
    Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).

  8. strength [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543243


Locations
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Switzerland
Bern University of Applied Science, Department Health
Bern, Switzerland, 3008
Sponsors and Collaborators
Bern University of Applied Sciences
Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology
Investigators
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Study Chair: Slavko Rogan, MSc Bern University of Applied Science, Department Health
Principal Investigator: Lorenz Radlinger, PhD Bern University of Applied Science, Department Health
Study Director: Dietmar Schmidtbleicher, PhD, Prof. Johann Wolfgang Goethe University Frankfurt am Main, Department Sport Science
Study Director: Rob de Bie, PhD, Prof. University Maastricht, Department Epidemiology
Study Director: Eling D de Bruin, PhD, Prof. Swiss Federal Institute of Technology Zurich, Department Human Movement Science
More Information
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Publications of Results:

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Responsible Party: Slavko Rogan, cand. PhD, PTMsc, PT MSc, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01543243    
Other Study ID Numbers: PhD pilot study 2
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Keywords provided by Slavko Rogan, cand. PhD, PTMsc, Bern University of Applied Sciences:
postural balance
strength