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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01704976
Other study ID # MSc-study (Biel)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date December 2014

Study information

Verified date January 2019
Source Bern University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
SR-WBV
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
SR-WBV
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.

Locations

Country Name City State
Switzerland Slavko Rogan Bern

Sponsors (1)

Lead Sponsor Collaborator
Bern University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Functional Performance Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.
The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is "Poor performance"; SPPB 7-9 is "Intermediate performance; SPPB 10-12 is "High Performance".
after 4 weeks
Secondary Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. after 4 weeks
Secondary Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint. after 4 weeks
Secondary Isometric Rate of Force Development (IRFD) Right Knee-extensor It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. after 4 weeks
Secondary Isometric Rate of Force Development (IRFD) Left Knee-extensor It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint. after 4 weeks
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