<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/NCT02981771</url>
  </required_header>
  <id_info>
    <org_study_id>0083-16-HYMC</org_study_id>
    <nct_id>NCT02981771</nct_id>
  </id_info>
  <brief_title>The Effect of Exercise Training Programs On Balance in Older Adults With CVD</brief_title>
  <official_title>The Effect of Exercise Training Programs - Stability and Coordination - On Static Balance, Dynamic Balance and Risk of Falls in Older Adults With Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of&#xD;
      this study is to explore the effect of specific exercise program based on balance and&#xD;
      coordination on stability parameters&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">December 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Balance ability - a composite outcome</measure>
    <time_frame>4 months</time_frame>
    <description>In order to assess changes in balance ability, it will be measured with the following tests:&#xD;
Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Aging</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>experiment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A physical activity program that is based on balance and coordination exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A physical activity program that is based on strength exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance activity program</intervention_name>
    <description>Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises</description>
    <arm_group_label>experiment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength activity program</intervention_name>
    <description>Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has Cardiovascular disease, under the supervision of a cardiologist&#xD;
&#xD;
          -  Participates in a cardiovascular rehabilitation center&#xD;
&#xD;
          -  Able to undergo physical activity for 60 minutes twice a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All Other&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zinman College for Physical Education and Sport Sciences</name>
      <address>
        <city>Wingate</city>
        <zip>42902</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 13, 2018</last_update_submitted>
  <last_update_submitted_qc>October 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02981771
org study id: 0083-16-HYMC
nct id: NCT02981771
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of
      this study is to explore the effect of specific exercise program based on balance and
      coordination on stability parameters
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in Balance ability - a composite outcome
time frame: 4 months
description: In order to assess changes in balance ability, it will be measured with the following tests:
Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared
arm group label: experiment
arm group type: Experimental
description: A physical activity program that is based on balance and coordination exercises
arm group label: control
arm group type: Placebo Comparator
description: A physical activity program that is based on strength exercises
intervention type: Behavioral
intervention name: Balance activity program
description: Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises
arm group label: experiment
intervention type: Behavioral
intervention name: Strength activity program
description: Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises
arm group label: control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Cardiovascular Diseases