- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01543243
Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control
Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control: a Pilot Study
This study aims to examine
- the feasibility
- immediately
- long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3008
- Bern University of Applied Science, Department Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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 |
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:
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:
|
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 |
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
effects after 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediate effects following one minute after a session of SR-WBV
|
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.
|
effects after 4 weeks
|
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.
|
immediate effects following one minute after a session of SR-WBV
|
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
|
effects after 4 weeks
|
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.
|
immediate effects following one minute after a session of SR-WBV
|
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.
|
effects after 4 weeks
|
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).
|
immediate effects following one minute after a session of SR-WBV
|
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).
|
effects after 4 weeks
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PhD pilot study 2
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