<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01713790</url>
  </required_header>
  <id_info>
    <org_study_id>Main study (PhD)- part II</org_study_id>
    <nct_id>NCT01713790</nct_id>
  </id_info>
  <brief_title>Innovative Training Methods for Frail Elderly in the Training Gain Stage</brief_title>
  <official_title>Effects of Whole Body Vibration With Stochastic Resonance and Exergames in the Elderly in Need of Care: Effects on Physical Functional Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bern University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Goethe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bern University of Applied Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine long term effects in the training gain stage of the falls&#xD;
      management exercise programs (FaME, from Skelton and Dinan) over 10 weeks on physical&#xD;
      functional performance after mechanical SR-WBV, dance therapy and strength training&#xD;
      intervention in a frail elderly population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is based on the guideline of falls management exercise programs (FaME; from&#xD;
      Skelton and Dinan).&#xD;
&#xD;
      The goals:&#xD;
&#xD;
      Skilling up: improvement in neuromuscular control, postural control and strengthening of&#xD;
      large muscle groups of the lower extremity.&#xD;
&#xD;
      Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth,&#xD;
      improvement of bone density and multi-sensory exercises.&#xD;
&#xD;
      First, a pilot study was conducted with untrained elderly (&quot;Effects of stochastic resonance&#xD;
      therapy on postural control in the elderly population&quot; (KEK Bern: No.228/09, Clinical Trial&#xD;
      Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly&#xD;
      (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects&#xD;
      on Postural Control Clinical Trial Registry: NCT01543243).&#xD;
&#xD;
      It was found that the selected chosen form of recruitment (presentation and advertisement)&#xD;
      and the measurements methods are suitable for untrained elderly. But for frail elderly the&#xD;
      chosen form of recruitment and the measurement methods are not sufficient.&#xD;
&#xD;
      For this study, adapted measurement parameters for balance, strength and cognition will be&#xD;
      used.&#xD;
&#xD;
      The goals of this study:&#xD;
&#xD;
      Evaluate the effects of&#xD;
&#xD;
        -  functional lower extremity&#xD;
&#xD;
        -  dynamic balance&#xD;
&#xD;
        -  reaction time&#xD;
&#xD;
        -  mobility&#xD;
&#xD;
        -  muscle strength and cognition.&#xD;
&#xD;
      This is a one-group pre-post design study and the participants will be recruited in Canton&#xD;
      Bern - Switzerland.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Physical Performance Battery (SPBB)</measure>
    <time_frame>Change from baseline in SPBB at 10 weeks.</time_frame>
    <description>The SPBB assess lower extremity function at baseline and after a 10-week interventions period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dynamic body balance</measure>
    <time_frame>Change from baseline in dynamic body balance at 10 weeks.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking in single (ST) and dual task (DT) conditions</measure>
    <time_frame>Change from baseline during walking in ST and DT condition at 10 weeks.</time_frame>
    <description>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.&#xD;
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.&#xD;
The time differences between the two tasks are evaluated at baseline and after a 10-week interventions period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mobility</measure>
    <time_frame>Change from baseline in mobility at 10 weeks.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee extension maximum voluntary contraction (MVC)</measure>
    <time_frame>Change from baseline in knee extension MVC at 10 weeks.</time_frame>
    <description>It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee extension rate of force develompent (RFD)</measure>
    <time_frame>Change from baseline in knee extension RFD at 10 weeks.</time_frame>
    <description>It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee flexion maximum voluntary contraction (MVC)</measure>
    <time_frame>Change from baseline in knee flexion MVC at 10 weeks.</time_frame>
    <description>It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee flexion rate of force develompent (RFD)</measure>
    <time_frame>Change from baseline in knee flexion RFD at 10 weeks.</time_frame>
    <description>It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Poor Performance Status</condition>
  <arm_group>
    <arm_group_label>Training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - T1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stochastic resonance whole-body vibration</intervention_name>
    <description>Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
    <arm_group_label>Training group</arm_group_label>
    <other_name>SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exergame</intervention_name>
    <description>training program over 10 weeks, three times a week.</description>
    <arm_group_label>Training group</arm_group_label>
    <other_name>Virtual game board</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Leg press</intervention_name>
    <description>training program over 10 weeks, three times a week.</description>
    <arm_group_label>Training group</arm_group_label>
    <other_name>Swiss Frei AG, Switzerland</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RAI (Resident Assessment Instrument) &gt;0&#xD;
&#xD;
          -  live in canton Bern&#xD;
&#xD;
          -  in terms of training load be resistant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue&#xD;
             damage, or acute -- surgical scars&#xD;
&#xD;
          -  seniors with prosthesis.&#xD;
&#xD;
          -  alcoholic&#xD;
&#xD;
          -  acute joint disease, activated osteoarthritis, rheumatoid arthritis&#xD;
&#xD;
          -  acute inflammation or infection tumors&#xD;
&#xD;
          -  fresh surgical wounds&#xD;
&#xD;
          -  severe migraine&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  acute severe pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Slavko Rogan, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Bern University of Applied Science, Department WGS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lorenz Radlinger, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bern University of Applied Science, Department WGS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dietmar Schmidtbleicher, Prof., PhD</last_name>
    <role>Study Director</role>
    <affiliation>Johann Wolfgang Goethe University, Department Sport Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rob de Bie, Prof., PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Maastricht, Department Epidemiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eling D de Bruin, Prof., PhD</last_name>
    <role>Study Director</role>
    <affiliation>Swiss Federal Institute of Technology Zurich, Department Human Movement Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Baur Heiner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bern University of Applied Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Slavko Rogan</name>
      <address>
        <city>Bern</city>
        <zip>3008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>July 22, 2015</last_update_submitted>
  <last_update_submitted_qc>July 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bern University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>Heiner Baur (PhD)</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>physical functional performance</keyword>
  <keyword>postural balance</keyword>
  <keyword>reaction time</keyword>
  <keyword>mobility</keyword>
  <keyword>muscle strength</keyword>
  <keyword>cognition</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01713790
org study id: Main study (PhD)- part II
nct id: NCT01713790
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Short Physical Performance Battery (SPBB)
time frame: Change from baseline in SPBB at 10 weeks.
description: The SPBB assess lower extremity function at baseline and after a 10-week interventions period.
measure: dynamic body balance
time frame: Change from baseline in dynamic body balance at 10 weeks.
description: 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.
measure: walking in single (ST) and dual task (DT) conditions
time frame: Change from baseline during walking in ST and DT condition at 10 weeks.
description: 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.
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.
measure: mobility
time frame: Change from baseline in mobility at 10 weeks.
description: 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.
measure: knee extension maximum voluntary contraction (MVC)
time frame: Change from baseline in knee extension MVC at 10 weeks.
description: It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
measure: knee extension rate of force develompent (RFD)
time frame: Change from baseline in knee extension RFD at 10 weeks.
description: It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
measure: knee flexion maximum voluntary contraction (MVC)
time frame: Change from baseline in knee flexion MVC at 10 weeks.
description: It will be evaluated by isometric MVC at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
measure: knee flexion rate of force develompent (RFD)
time frame: Change from baseline in knee flexion RFD at 10 weeks.
description: It will be evaluated by isometric RFD at 90 degree angle in the knee joint at baseline and after a 10-week interventions period.
arm group label: Training group
arm group type: Experimental
description: T0 - Intervention program 3x/ week over 10 weeks: Stochastic resonance whole-body vibration + Exergame + leg press - T1
intervention type: Device
intervention name: Stochastic resonance whole-body vibration
description: Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.
arm group label: Training group
other name: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
intervention type: Device
intervention name: Exergame
description: training program over 10 weeks, three times a week.
arm group label: Training group
other name: Virtual game board
intervention type: Device
intervention name: Leg press
description: training program over 10 weeks, three times a week.
arm group label: Training group
other name: Swiss Frei AG, Switzerland
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Slavko Rogan, MSc
role: Study Chair
affiliation: Bern University of Applied Science, Department WGS
last name: Lorenz Radlinger, PhD
role: Study Director
affiliation: Bern University of Applied Science, Department WGS
last name: Dietmar Schmidtbleicher, Prof., PhD
role: Study Director
affiliation: Johann Wolfgang Goethe University, Department Sport Science
last name: Rob de Bie, Prof., PhD
role: Study Director
affiliation: University Maastricht, Department Epidemiology
last name: Eling D de Bruin, Prof., PhD
role: Study Director
affiliation: Swiss Federal Institute of Technology Zurich, Department Human Movement Science
last name: Baur Heiner, PhD
role: Principal Investigator
affiliation: Bern University of Applied Sciences
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Bern University of Applied Sciences
investigator full name: Heiner Baur (PhD)
investigator title: PhD