Clinical trial NCT01704976: SR-WBV Training for Frail Elderly in the Skilling up Stage
Official title: Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Performance Status
Muscle Weakness
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.

Detailed description: This study is based on the guideline of falls management exercise programs (FaME; from Skelton and Dinan).

The goals:

Skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.

Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth, improvement of bone density and multi-sensory exercises.

First, a pilot study was conducted with untrained elderly ("Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Clinical Trial Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control Clinical Trial Registry:NCT01543243).

It was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. But for frail elderly the chosen form of recruitment and the measurement methods are not sufficient.

For this study, measurement parameters for functional performance and strength will be used.

Goals of the study in the skilling up phase:

1. Feasibility
2. Study the effect on physical functional performance
3. Study the effects on muscle strength.

The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.

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: Physical Functional Performance
timeFrame: after 4 weeks
Secondary outcomes:
measure: Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
timeFrame: after 4 weeks
measure: Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
timeFrame: after 4 weeks
measure: Isometric Rate of Force Development (IRFD) Right Knee-extensor
timeFrame: after 4 weeks
measure: Isometric Rate of Force Development (IRFD) Left Knee-extensor
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Slavko Rogan
Study officials:
affiliation: Bern University of Applied Science, Department WGS
name: Rogan Slavko, MSc
role: STUDY_CHAIR
affiliation: Bern University of Applied Science, Department WGS
name: Radlinger Lorenz, PhD
role: STUDY_DIRECTOR
affiliation: Bern University of Applied Sciences
name: Baur Heiner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BUAS
name: Jessica Kessler, MSc
role: STUDY_CHAIR
References:
citation: Kessler J, Radlinger L, Baur H, Rogan S. Effect of stochastic resonance whole body vibration on functional performance in the frail elderly: A pilot study. Arch Gerontol Geriatr. 2014 Sep-Oct;59(2):305-11. doi: 10.1016/j.archger.2014.06.005. Epub 2014 Jul 9.