<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/NCT01704976</url>
  </required_header>
  <id_info>
    <org_study_id>MSc-study (Biel)</org_study_id>
    <nct_id>NCT01704976</nct_id>
  </id_info>
  <brief_title>SR-WBV Training for Frail Elderly in the Skilling up Stage</brief_title>
  <official_title>Effects of Whole Body Vibration With Stochastic Resonance and Dance Therapy in the Elderly: Effects on Physical Functional Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bern University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bern University of Applied Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled study aims to examine long term effects in the skilling up phase&#xD;
      over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance&#xD;
      therapy 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, measurement parameters for functional performance and strength will be used.&#xD;
&#xD;
      Goals of the study in the skilling up phase:&#xD;
&#xD;
        1. Feasibility&#xD;
&#xD;
        2. Study the effect on physical functional performance&#xD;
&#xD;
        3. Study the effects on muscle strength.&#xD;
&#xD;
      The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated&#xD;
      to an intervention group or sham group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Functional Performance</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>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.&#xD;
The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is &quot;Poor performance&quot;; SPPB 7-9 is &quot;Intermediate performance; SPPB 10-12 is &quot;High Performance&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric Rate of Force Development (IRFD) Right Knee-extensor</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric Rate of Force Development (IRFD) Left Knee-extensor</measure>
    <time_frame>after 4 weeks</time_frame>
    <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Poor Performance Status</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SR-WBV</intervention_name>
    <description>Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)</other_name>
    <other_name>Intervention-Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SR-WBV</intervention_name>
    <description>Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
    <arm_group_label>Sham group</arm_group_label>
    <other_name>SRT Zeptor® med plus Noise (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, acute lower limb&#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>Rogan Slavko, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Bern University of Applied Science, Department WGS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radlinger Lorenz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bern University of Applied Science, Department WGS</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>
  <overall_official>
    <last_name>Jessica Kessler, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>BUAS</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>January 2019</verification_date>
  <study_first_submitted>October 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>July 12, 2014</results_first_submitted>
  <results_first_submitted_qc>December 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 24, 2014</results_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>Slavko Rogan</investigator_full_name>
    <investigator_title>PTMsc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
        </group>
        <group group_id="P2">
          <title>Sham</title>
          <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13">One participant completed &lt; 11 SR-WBV sessions and was excluded from the statistical analysis</participants>
                <participants group_id="P2" count="11">2 participants completed &lt; 11 SR-WBV sessions, they were excluded from statistical analysis</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
        </group>
        <group group_id="B2">
          <title>Sham</title>
          <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90.7" spread="7.5"/>
                    <measurement group_id="B2" value="83.8" spread="9.3"/>
                    <measurement group_id="B3" value="87.3" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total sum score of the Short Physical Performance Battery Test</title>
          <description>&quot;Short physical performance battery (SPBB): The SPBB examines three areas of lower extremity function:&#xD;
standing balance (semi-tandem stand, side-by-side stand, full tandem stand),&#xD;
walking speed and&#xD;
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 &quot;Poor performance&quot;; SPPB 7-9 is &quot;Intermediate performance; SPPB 10-12 is &quot;High Performance.&quot;.</description>
          <units>sum of points</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="2" upper_limit="4.5"/>
                    <measurement group_id="B2" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="B3" value="3" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Physical Functional Performance</title>
        <description>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.&#xD;
The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is &quot;Poor performance&quot;; SPPB 7-9 is &quot;Intermediate performance; SPPB 10-12 is &quot;High Performance&quot;.</description>
        <time_frame>after 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functional Performance</title>
          <description>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.&#xD;
The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is &quot;Poor performance&quot;; SPPB 7-9 is &quot;Intermediate performance; SPPB 10-12 is &quot;High Performance&quot;.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="4.5"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3.5" upper_limit="7.5"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor</title>
        <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
        <time_frame>after 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor</title>
          <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
          <units>Newton</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.1" lower_limit="79" upper_limit="183"/>
                    <measurement group_id="O2" value="141.4" lower_limit="95" upper_limit="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.1" lower_limit="93" upper_limit="164"/>
                    <measurement group_id="O2" value="128.7" lower_limit="69" upper_limit="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension</title>
        <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
        <time_frame>after 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension</title>
          <description>It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.</description>
          <units>Newton</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" lower_limit="68" upper_limit="195"/>
                    <measurement group_id="O2" value="115.8" lower_limit="77" upper_limit="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154" lower_limit="91" upper_limit="211"/>
                    <measurement group_id="O2" value="129" lower_limit="48" upper_limit="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Isometric Rate of Force Development (IRFD) Right Knee-extensor</title>
        <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
        <time_frame>after 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Isometric Rate of Force Development (IRFD) Right Knee-extensor</title>
          <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
          <units>Newton/seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="489.8" lower_limit="223" upper_limit="1307"/>
                    <measurement group_id="O2" value="558.5" lower_limit="412" upper_limit="1272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="510" lower_limit="295" upper_limit="1166"/>
                    <measurement group_id="O2" value="560" lower_limit="256" upper_limit="906"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Isometric Rate of Force Development (IRFD) Left Knee-extensor</title>
        <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
        <time_frame>after 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Isometric Rate of Force Development (IRFD) Left Knee-extensor</title>
          <description>It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.</description>
          <units>Newton/seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="284.7" lower_limit="190" upper_limit="1100"/>
                    <measurement group_id="O2" value="546.2" lower_limit="347" upper_limit="920"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580.3" lower_limit="247" upper_limit="1140"/>
                    <measurement group_id="O2" value="521" lower_limit="154" upper_limit="793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>zero period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>T0 - intervention 4 weeks - T1&#xD;
Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.</description>
        </group>
        <group group_id="E2">
          <title>Sham</title>
          <description>T0- Intervention 4 weeks- T1&#xD;
Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Slavko Rogan (Study Chair)</name_or_title>
      <organization>BUAS</organization>
      <phone>+41 31 848 35 56</phone>
      <email>slavko.rogan@bfh.ch</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01704976
org study id: MSc-study (Biel)
nct id: NCT01704976
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Physical Functional Performance
time frame: after 4 weeks
description: 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".
measure: Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor
time frame: after 4 weeks
description: It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
measure: Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension
time frame: after 4 weeks
description: It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.
measure: Isometric Rate of Force Development (IRFD) Right Knee-extensor
time frame: after 4 weeks
description: It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
measure: Isometric Rate of Force Development (IRFD) Left Knee-extensor
time frame: after 4 weeks
description: It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.
arm group label: Intervention
arm group type: Experimental
description: T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (5 Hz, noise 4) - T1
arm group label: Sham group
arm group type: Sham Comparator
description: T0 - intervention over 4 weeks with stochastic resonance whole-body vibration (SR-WBV) (1 Hz, noise 1) - T1
intervention type: Device
intervention name: SR-WBV
description: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
arm group label: Intervention
other name: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland)
other name: Intervention-Group
intervention type: Device
intervention name: SR-WBV
description: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
arm group label: Sham group
other name: SRT Zeptor® med plus Noise (Swiss Frei AG, Switzerland
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rogan Slavko, MSc
role: Study Chair
affiliation: Bern University of Applied Science, Department WGS
last name: Radlinger Lorenz, PhD
role: Study Director
affiliation: Bern University of Applied Science, Department WGS
last name: Baur Heiner, PhD
role: Principal Investigator
affiliation: Bern University of Applied Sciences
last name: Jessica Kessler, MSc
role: Study Chair
affiliation: BUAS
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Bern University of Applied Sciences
investigator full name: Slavko Rogan
investigator title: PTMsc
mesh term: Muscle Weakness
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 