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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01543243
First received: September 26, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Equilibration Disorder, Vestibular Nerve
 Device: Stochastic resonance whole-body vibration
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Noise
U.S. FDA Resources

Further study details as provided by Bern University of Applied Sciences:

Primary Outcome Measures:
  • Dynamic body balance [ Time Frame: effects after 4 weeks ] [ Designated as safety issue: Yes ]
    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:
  • static body balance [ Time Frame: immediately effects following one minute after a session of SR-WBV ] [ Designated as safety issue: Yes ]
    Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured.

  • static body balance [ Time Frame: effects after 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: immediately effects following one minute after a session of SR-WBV ] [ Designated as safety issue: Yes ]
    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.

  • dynamic body balance [ Time Frame: effects after 4 weeks ] [ Designated as safety issue: Yes ]
    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

  • Lower extremity performance [ Time Frame: immediately effects following one minute after a session of SR-WBV ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: effects after 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: immediately effects following one minute after a session of SR-WBV ] [ Designated as safety issue: Yes ]
    Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).

  • strength [ Time Frame: effects after 4 weeks ] [ Designated as safety issue: Yes ]
    Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).


Enrollment: 30
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
  • T0, intervention, immediately T1 (one minute after intervention), 7 days wash-out period; T2, intervention, immediately T3 (one minute after intervention)
  • T4, intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, intervention over four weeks, three times week, T7
 Device: Stochastic resonance whole-body vibration
  • Immediately 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
  • Immediately 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

  • T0, intervention, immediately T1 (one minute after intervention)

    , 7 days wash-out period; T2, intervention, immediately T3 (one minute after intervention)

  • T4, intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, intervention over four weeks, three times week, T7
 Device: Stochastic resonance whole-body vibration
  • Immediately 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
  • Immediately 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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543243

Locations
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
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

No publications provided

Responsible Party: Slavko Rogan, cand. PhD, PTMsc, PT MSc, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01543243     History of Changes
Other Study ID Numbers: SR-WBV Study 2
Study First Received: September 26, 2011
Last Updated: February 5, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Bern University of Applied Sciences:
postural balance
strength

ClinicalTrials.gov processed this record on May 16, 2013