Clinical trial NCT01543243: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Equilibration Disorder, Vestibular Nerve
Keywords: postural balance
strength
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Goethe University
name: Maastricht University Medical Center
name: Swiss Federal Institute of Technology
First posted: 2012-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dynamic body balance
timeFrame: effects after 4 weeks
Secondary outcomes:
measure: static body balance
timeFrame: immediate effects following one minute after a session of SR-WBV
measure: static body balance
timeFrame: effects after 4 weeks
measure: dynamic body balance
timeFrame: immediate effects following one minute after a session of SR-WBV
measure: dynamic body balance
timeFrame: effects after 4 weeks
measure: Lower extremity performance
timeFrame: immediate effects following one minute after a session of SR-WBV
measure: Lower extermity performance
timeFrame: effects after 4 weeks
measure: strength
timeFrame: immediate effects following one minute after a session of SR-WBV
measure: strength
timeFrame: effects after 4 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University of Applied Science, Department Health
Study officials:
affiliation: Bern University of Applied Science, Department Health
name: Slavko Rogan, MSc
role: STUDY_CHAIR
affiliation: Bern University of Applied Science, Department Health
name: Lorenz Radlinger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johann Wolfgang Goethe University Frankfurt am Main, Department Sport Science
name: Dietmar Schmidtbleicher, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: University Maastricht, Department Epidemiology
name: Rob de Bie, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: Swiss Federal Institute of Technology Zurich, Department Human Movement Science
name: Eling D de Bruin, PhD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.