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

NCT01543243 | Completed Phase 2

• 1 other identifier: PhD pilot study 2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine

1. 1.the feasibility
2. 2.immediately
3. 3.long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

Conditions

Equilibration Disorder, Vestibular Nerve

Keywords

postural balance; strength

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• static body balance

  immediate effects following one minute after a session of SR-WBV

• static body balance

  effects after 4 weeks

• dynamic body balance

  immediate effects following one minute after a session of SR-WBV

• dynamic body balance

  effects after 4 weeks

• Lower extremity performance

  immediate effects following one minute after a session of SR-WBV

Study Arms (2)

Group 1

EXPERIMENTAL

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; Device: Stochastic resonance whole-body vibration B

Group 2

EXPERIMENTAL

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; Device: Stochastic resonance whole-body vibration B

Interventions

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.

Also known as: SRT Zeptor® med plus Noise

Group 1; Group 2

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.

Also known as: SRT Zeptor® med plus Noise

Group 1; Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• RAI (Resident Assessment Instrument) \>0
• live in canton Bern
• in terms of training load be resistant.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bern University of Applied Sciences: lead
• Goethe University: collaborator
• Maastricht University Medical Center: collaborator
• Swiss Federal Institute of Technology: collaborator

Study Sites (1)

Bern University of Applied Science, Department Health

Bern, Canton of Bern, 3008, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 24700493 RESULT

• 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.

  PMID: 26865869 RESULT

Study Officials

• Slavko Rogan, MSc

  Bern University of Applied Science, Department Health

  STUDY CHAIR

• Lorenz Radlinger, PhD

  Bern University of Applied Science, Department Health

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT MSc

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: March 2, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CH (1)