<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/NCT02190045</url>
  </required_header>
  <id_info>
    <org_study_id>404039</org_study_id>
    <nct_id>NCT02190045</nct_id>
  </id_info>
  <brief_title>Wii-Fit For Balance And Gait In Elderly Veterans</brief_title>
  <official_title>Wii-Fit For Balance And Gait In Elderly Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Arkansas Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Arkansas Veterans Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls are a major public health problem. They are the leading cause of injuries and&#xD;
      injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major&#xD;
      reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly.&#xD;
      Despite the many proven benefits of exercise, many older adults in the US remain sedentary.&#xD;
      This study targets at improving balance and gait with use of Wii-Fit as an exercise program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives/Rationale Falls are a major public health problem. They are the leading cause of&#xD;
      injuries and injury-related deaths in those aged over 65 years. Balance and gait&#xD;
      abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and&#xD;
      balance in the elderly. Despite the many proven benefits of exercise, many older adults in&#xD;
      the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit&#xD;
      as an exercise program.&#xD;
&#xD;
      Specific aims&#xD;
&#xD;
        1. To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to&#xD;
           improve measures of balance, and gait in older adults, compared to a cognitive&#xD;
           remediation program, Brain fitness.&#xD;
&#xD;
        2. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures&#xD;
           of biomechanical assessment, adherence, safety, physical activity, fear of fall,&#xD;
           enjoyment, functional status, cognition and quality of life.&#xD;
&#xD;
      Design 8-week, randomized, parallel group, active intervention study Methods Patients will be&#xD;
      recruited via IRB approved flyers posted in various locations of the Little Rock and North&#xD;
      Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly&#xD;
      Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will&#xD;
      participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks.&#xD;
      Outcome measures will be assessed at baseline, and approximately week 4 and after completion&#xD;
      of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome&#xD;
      measures include biomechanical testing for gait and balance, Safety, Adherence, measures of&#xD;
      functional status, cognition, quality of life, fear of falling, physical activity and&#xD;
      physical activity enjoyment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from &quot;0&quot; (lowest level of function) to &quot;4&quot; (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (SF-36)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Status Measures</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities Specific Balance Confidence Scale</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Mini- Mental Exam</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gait, Unsteady</condition>
  <condition>Postural Balance</condition>
  <arm_group>
    <arm_group_label>Wii-Fit program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive remediation program</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wii-Fit exercises</intervention_name>
    <description>Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
    <arm_group_label>Wii-Fit program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive remediation exercises</intervention_name>
    <description>Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
    <arm_group_label>Cognitive remediation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects age ≥ 60 years&#xD;
&#xD;
          -  Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52&#xD;
&#xD;
          -  Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24)&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects using wheel chair or walkers for mobility&#xD;
&#xD;
          -  Subjects with absolute contraindications per ACSM guidelines&#xD;
&#xD;
          -  Any medical condition (per the relative contraindications per ACSM guidelines below)&#xD;
             that in the opinion of the study physician is likely to compromise their ability to&#xD;
             safely participate in the exercise program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kalpana Padala, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Arkansas Veterans Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System (3J/NLR)</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>January 23, 2018</results_first_submitted>
  <results_first_submitted_qc>January 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2018</results_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Arkansas Veterans Healthcare System</investigator_affiliation>
    <investigator_full_name>Kalpana Padala, MD</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Balance</keyword>
  <keyword>gait</keyword>
  <keyword>Wii-Fit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wii-Fit Program</title>
          <description>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
        </group>
        <group group_id="P2">
          <title>Cognitive Remediation Program</title>
          <description>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wii-Fit Program</title>
          <description>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
        </group>
        <group group_id="B2">
          <title>Cognitive Remediation Program</title>
          <description>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="8.1"/>
                    <measurement group_id="B2" value="69.0" spread="3.8"/>
                    <measurement group_id="B3" value="68.0" spread="6.7"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Non-Hispanic Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Berg Balance Scale</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.5" spread="2.6"/>
                    <measurement group_id="B2" value="50.1" spread="2.5"/>
                    <measurement group_id="B3" value="49.3" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Berg Balance Scale</title>
        <description>The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from &quot;0&quot; (lowest level of function) to &quot;4&quot; (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wii-Fit Program</title>
            <description>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Remediation Program</title>
            <description>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Scale</title>
          <description>The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from &quot;0&quot; (lowest level of function) to &quot;4&quot; (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.5" spread="2.6"/>
                    <measurement group_id="O2" value="50.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (SF-36)</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Status Measures</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Activities Specific Balance Confidence Scale</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Mini- Mental Exam</title>
        <time_frame>8 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Wii-Fit Program</title>
          <description>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Wii-Fit exercises: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>Cognitive Remediation Program</title>
          <description>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks&#xD;
Cognitive remediation exercises: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>Kalpana Padala, MD</name_or_title>
      <organization>CAVHS/ UAMS</organization>
      <phone>501-257-1000</phone>
      <email>kppadala@uams.edu</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/NCT02190045
org study id: 404039
nct id: NCT02190045
lead sponsor: 
has dmc: No
Falls are a major public health problem. They are the leading cause of injuries and
      injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major
      reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly.
      Despite the many proven benefits of exercise, many older adults in the US remain sedentary.
      This study targets at improving balance and gait with use of Wii-Fit as an exercise program.
Objectives/Rationale Falls are a major public health problem. They are the leading cause of
      injuries and injury-related deaths in those aged over 65 years. Balance and gait
      abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and
      balance in the elderly. Despite the many proven benefits of exercise, many older adults in
      the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit
      as an exercise program.

      Specific aims

        1. To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to
           improve measures of balance, and gait in older adults, compared to a cognitive
           remediation program, Brain fitness.

        2. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures
           of biomechanical assessment, adherence, safety, physical activity, fear of fall,
           enjoyment, functional status, cognition and quality of life.

      Design 8-week, randomized, parallel group, active intervention study Methods Patients will be
      recruited via IRB approved flyers posted in various locations of the Little Rock and North
      Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly
      Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will
      participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks.
      Outcome measures will be assessed at baseline, and approximately week 4 and after completion
      of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome
      measures include biomechanical testing for gait and balance, Safety, Adherence, measures of
      functional status, cognition, quality of life, fear of falling, physical activity and
      physical activity enjoyment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Berg Balance Scale
time frame: 8 weeks
description: The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device.
measure: Quality of Life (SF-36)
time frame: 8 weeks
measure: Functional Status Measures
time frame: 8 weeks
measure: Activities Specific Balance Confidence Scale
time frame: 8 weeks
measure: Modified Mini- Mental Exam
time frame: 8 weeks
arm group label: Wii-Fit program
arm group type: Experimental
description: Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
arm group label: Cognitive remediation program
arm group type: Placebo Comparator
description: Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
intervention type: Other
intervention name: Wii-Fit exercises
description: Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
arm group label: Wii-Fit program
intervention type: Other
intervention name: Cognitive remediation exercises
description: Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
arm group label: Cognitive remediation program
criteria: 
gender: All
minimum age: 60 Years
maximum age: 95 Years
healthy volunteers: No
last name: Kalpana Padala, MD
role: Principal Investigator
affiliation: Central Arkansas Veterans Healthcare System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Central Arkansas Veterans Healthcare System
investigator full name: Kalpana Padala, MD
investigator title: Staff Physician
mesh term: Gait Disorders, Neurologic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 