Innovative Training Methods for Frail Elderly in the Training Gain Stage

July 22, 2015 updated by: Heiner Baur (PhD), Bern University of Applied Sciences

Effects of Whole Body Vibration With Stochastic Resonance and Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance

This study aims to examine long term effects in the training gain stage of the falls management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical functional performance after mechanical SR-WBV, dance therapy and strength training 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, adapted measurement parameters for balance, strength and cognition will be used.

The goals of this study:

Evaluate the effects of

  • functional lower extremity
  • dynamic balance
  • reaction time
  • mobility
  • muscle strength and cognition.

This is a one-group pre-post design study and the participants will be recruited in Canton Bern - Switzerland.

Study Type

Interventional

Enrollment (Actual)

40

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 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Training group
T0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - T1
Device: Stochastic resonance whole-body vibration
Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Names:
  • SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
Device: Exergame
training program over 10 weeks, three times a week.
Other Names:
  • Virtual game board
Device: Leg press
training program over 10 weeks, three times a week.
Other Names:
  • Swiss Frei AG, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPBB)
Time Frame: Change from baseline in SPBB at 10 weeks.
The SPBB assess lower extremity function at baseline and after a 10-week interventions period.
Change from baseline in SPBB at 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dynamic body balance
Time Frame: Change from baseline in dynamic body balance at 10 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. In the ETGUG test, times for the component tasks are measured at baseline and after a 10-week interventions period.
Change from baseline in dynamic body balance at 10 weeks.
walking in single (ST) and dual task (DT) conditions
Time Frame: Change from baseline during walking in ST and DT condition at 10 weeks.
  1. For the single task condition, the participants will be instructed to walk a distance of 20 meters at their self-selected walking speed. Total time were measured.

  2. For the dual task condition, the participant had to count backwards from the number 250 in steps of 7 while walking the same distance at their self-selected walking speed. Total walking times were measured.

    • The time differences between the two tasks are evaluated at baseline and after a 10-week interventions period.
Change from baseline during walking in ST and DT condition at 10 weeks.
mobility
Time Frame: Change from baseline in mobility at 10 weeks.
The participants using a StepWatch ™ Activity Monitor (SAM) pedometer. This digital pedometer record the total daily steps at baseline and after a 10-week interventions period.
Change from baseline in mobility at 10 weeks.
knee extension maximum voluntary contraction (MVC)
Time Frame: Change from baseline in knee extension MVC at 10 weeks.
It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Change from baseline in knee extension MVC at 10 weeks.
knee extension rate of force develompent (RFD)
Time Frame: Change from baseline in knee extension RFD at 10 weeks.
It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Change from baseline in knee extension RFD at 10 weeks.
knee flexion maximum voluntary contraction (MVC)
Time Frame: Change from baseline in knee flexion MVC at 10 weeks.
It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Change from baseline in knee flexion MVC at 10 weeks.
knee flexion rate of force develompent (RFD)
Time Frame: Change from baseline in knee flexion RFD at 10 weeks.
It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
Change from baseline in knee flexion RFD at 10 weeks.

Collaborators and Investigators

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

Sponsor

Bern University of Applied Sciences

Collaborators

Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology

Investigators

  • Study Chair: Slavko Rogan, MSc, Bern University of Applied Science, Department WGS
  • Study Director: Dietmar Schmidtbleicher, Prof., PhD, Johann Wolfgang Goethe University, Department Sport Science
  • Study Director: Rob de Bie, Prof., PhD, University Maastricht, Department Epidemiology
  • Study Director: Eling D de Bruin, Prof., PhD, Swiss Federal Institute of Technology Zurich, Department Human Movement Science

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

October 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

October 14, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (ESTIMATE)

October 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Main study (PhD)- part II

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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