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

• ClinicalTrials.gov Identifier: NCT01543243
• Recruitment Status: Completed
• First Posted: March 2, 2012
• Last Update Posted: June 14, 2016
• Sponsor: Bern University of Applied Sciences
• 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

Tracking Information

• First Submitted Date: September 26, 2011
• First Posted Date: March 2, 2012
• Last Update Posted Date: June 14, 2016
• Study Start Date: November 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 27, 2012)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 19, 2014)

• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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).
• 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).

Original Secondary Outcome Measures (submitted: February 27, 2012)

• static body balance [ Time Frame: immediately 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.
• 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.
• dynamic body balance [ Time Frame: immediately 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.
• 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
• Lower extremity performance [ Time Frame: immediately 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 [ 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.
• strength [ Time Frame: immediately 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).
• 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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.

  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

Study Arms

• 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

  Interventions:

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

  Interventions:

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

Publications *

• 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):519-27. doi: 10.1007/s40520-014-0212-4. Epub 2014 Apr 4.
• 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 vibration. Eur Rev Aging Phys Act. 2015 Oct 9;12:5. doi: 10.1186/s11556-015-0150-y. eCollection 2015.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 27, 2012): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01543243
• Other Study ID Numbers: PhD pilot study 2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Slavko Rogan, cand. PhD, PTMsc, Bern University of Applied Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Bern University of Applied Sciences
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Bern University of Applied Sciences
• Verification Date: June 2016