SR-WBV Training for Frail Elderly in the Skilling up Stage

January 28, 2019 updated by: Slavko Rogan, Bern University of Applied Sciences

Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
Device: SR-WBV
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Names:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
  • Intervention-Group
Device: SR-WBV
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Other Names:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland
Sham Comparator: Sham group
T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
Device: SR-WBV
Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Names:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
  • Intervention-Group
Device: SR-WBV
Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
Other Names:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Functional Performance
Time Frame: after 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
Time Frame: after 4 weeks
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
after 4 weeks
Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
Time Frame: after 4 weeks
It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
after 4 weeks
Isometric Rate of Force Development (IRFD) Right Knee-extensor
Time Frame: after 4 weeks
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
after 4 weeks
Isometric Rate of Force Development (IRFD) Left Knee-extensor
Time Frame: after 4 weeks
It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bern University of Applied Sciences

Investigators

  • Study Chair: Rogan Slavko, MSc, Bern University of Applied Science, Department WGS
  • Study Director: Radlinger Lorenz, PhD, Bern University of Applied Science, Department WGS
  • Study Chair: Jessica Kessler, MSc, BUAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 7, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSc-study (Biel)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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