Innovative Training Methods for Frail Elderly in the Training Gain Stage

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bern University of Applied Sciences
Sponsor:
Collaborators:
Goethe University
Maastricht University Medical Center
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Heiner Baur (PhD), Bern University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01713790
First received: October 14, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Frail Elderly
Device: Stochastic resonance whole-body vibration
Device: Dance Therapy
Device: Leg press

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance

Resource links provided by NLM:


Further study details as provided by Bern University of Applied Sciences:

Primary Outcome Measures:
  • Short Physical Performance Battery (SPBB) [ Time Frame: Change from baseline in SPBB at 10 weeks. ] [ Designated as safety issue: Yes ]
    The SPBB assess lower extremity function at baseline and after a 10-week interventions period.


Secondary Outcome Measures:
  • dynamic body balance [ Time Frame: Change from baseline in dynamic body balance at 10 weeks. ] [ Designated as safety issue: No ]
    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.

  • vertical ground reaction force (VGRF) during chair rising [ Time Frame: Change from baseline in VGRF during chair rising at 10 weeks. ] [ Designated as safety issue: No ]
    The participants should rise from a chair as quickly as possible, to recover balance and to stand upright as fast as possible for 20 seconds. Vertical ground reaction force (VGRF) during chair rising will be measured at baseline and after a 10-week interventions period.

  • walking in single (ST) and dual task (DT) conditions [ Time Frame: Change from baseline during walking in ST and DT condition at 10 weeks. ] [ Designated as safety issue: No ]
    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.

  • cognition [ Time Frame: Change from baseline in cognition at 10 weeks. ] [ Designated as safety issue: No ]
    The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. Two versions are available: A, in which the targets are all numbers (1,2,3, etc.), and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.). The goal of the subject is to finish the test as quickly as possible while still maintaining accuracy at baseline and after a 10-week interventions period.

  • mobility [ Time Frame: Change from baseline in mobility at 10 weeks. ] [ Designated as safety issue: No ]
    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.

  • knee extension maximum voluntary contraction (MVC) [ Time Frame: Change from baseline in knee extension MVC at 10 weeks. ] [ Designated as safety issue: No ]
    It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  • knee extension rate of force develompent (RFD) [ Time Frame: Change from baseline in knee extension RFD at 10 weeks. ] [ Designated as safety issue: No ]
    It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  • knee flexion maximum voluntary contraction (MVC) [ Time Frame: Change from baseline in knee flexion MVC at 10 weeks. ] [ Designated as safety issue: No ]
    It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  • knee flexion rate of force develompent (RFD) [ Time Frame: Change from baseline in knee flexion RFD at 10 weeks. ] [ Designated as safety issue: No ]
    It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.

  • hand reaction time (RTH) [ Time Frame: Change from baseline in RTH at 10 weeks. ] [ Designated as safety issue: No ]
    Reaction time from the hand (RTH) will be measured with a finger push-button as the response to a random light stimulus at baseline and after a 10-week interventions period. The system measured the elapsed time from the release of the light stimulus to the moment the button was pressed.

  • foot reaction time (RTF) [ Time Frame: Change from baseline in RTF at 10 weeks. ] [ Designated as safety issue: No ]
    Reaction time from the foot (RTF) will be measured with a foot push-button as the response to a random light stimulus at baseline and after a 10-week interventions period. The system measured the elapsed time from the release of the light stimulus to the moment the button was pressed.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training group
T0 - Intervention program 3x/ week over 10 weeks: SR-WBV + Dance Therapy + leg press - T1
Device: Stochastic resonance whole-body vibration
training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.
Other Name: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
Device: Dance Therapy
training program over 10 weeks, three times a week.
Other Name: Dance Therapy (TX 6000 Metal DDR Platinum Pro, Mayflash Limited, Baoan Shenzhen, China) and StepMania (Version 3.9) software.
Device: Leg press
training program over 10 weeks, three times a week.
Other Name: Swiss Frei AG, Switzerland

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 inflammation or infection tumors
  • fresh surgical wounds
  • severe migraine
  • epilepsy
  • acute severe pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713790

Contacts
Contact: Slavko Rogan, MSc +41 31 848 35 56 slavko.rogan@bfh.ch

Locations
Switzerland
Slavko Rogan Recruiting
Bern, Switzerland, 3008
Contact: Slavko Rogan, MSc    +41 31 848 35 56    slavko.rogan@bfh.ch   
Principal Investigator: Slavko Rogan, MSc         
Sponsors and Collaborators
Bern University of Applied Sciences
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: Lorenz Radlinger, PhD 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
Principal Investigator: Baur Heiner, PhD Bern University of Applied Sciences
  More Information

No publications provided

Responsible Party: Heiner Baur (PhD), PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01713790     History of Changes
Other Study ID Numbers: SR-WBV.Study 3-C
Study First Received: October 14, 2012
Last Updated: March 31, 2014
Health Authority: Switzerland: KEK Bern

Keywords provided by Bern University of Applied Sciences:
physical functional performance
postural balance
reaction time
mobility
muscle strength
cognition

ClinicalTrials.gov processed this record on October 23, 2014