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Completed

NCT Number: NCT01543243

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

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.

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Key information

Conditions

Equilibration Disorder, Vestibular Nerve

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bern University of Applied Science, Department Health

Bern, Canton of Bern, 3008, Switzerland

About this study

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:

  • improving the balance
  • improvement in functional capacity
  • improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

  • Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
  • Training Gain: with the aim to improve functional abilities.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stochastic resonance whole-body vibration A

Device

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 names: SRT Zeptor® med plus Noise

Stochastic resonance whole-body vibration b

Device

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 names: SRT Zeptor® med plus Noise

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Collaborators

  • Goethe University
  • Maastricht University Medical Center
  • Swiss Federal Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2012
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.