<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/NCT02235922</url>
  </required_header>
  <id_info>
    <org_study_id>LAPESI-01</org_study_id>
    <nct_id>NCT02235922</nct_id>
  </id_info>
  <brief_title>Effects of a Dual Task Protocol on Cognition and Functionality in Non-sedentary Older Adults</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Sao Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Sao Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the effects of a dual task protocol on cognitive&#xD;
      domains and functional capacity in non-sedentary older adults.&#xD;
&#xD;
      The hypothesis of the present study is that older people undergoing to a dual task exercise&#xD;
      protocol have greater benefits on cognition and functional performance, compared to a&#xD;
      standard exercise protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes on cognition after 3 months of training</measure>
    <time_frame>Assessed at baseline and after 3 months of training</time_frame>
    <description>Cognition was assessed by Montreal Cognitive Assessment and Mini-Mental State Examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes on functional capacity after 3 months of training</measure>
    <time_frame>Assessed at baseline and after 3 months of training</time_frame>
    <description>Functional capacity was assessed by Timed up and go test, Timed up and go test associated to a cognitive task and sit to stand test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Non-sedentary</condition>
  <arm_group>
    <arm_group_label>Dual task training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual task training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dual task training</intervention_name>
    <description>The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.</description>
    <arm_group_label>Dual task training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional training</intervention_name>
    <description>The conventional training consisted of individuals subjected to a multicomponent exercise program.</description>
    <arm_group_label>Conventional training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged over 60 years&#xD;
&#xD;
          -  community people&#xD;
&#xD;
          -  ability to walk alone&#xD;
&#xD;
          -  non-sedentary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-realization of any cognitive or functional assessment&#xD;
&#xD;
          -  presence of Parkinson's Disease, Dementia and Stroke with motor sequel&#xD;
&#xD;
          -  frequency to trainings below 70%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anielle Takahashi, doctorate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Sao Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de São Carlos</name>
      <address>
        <city>São Carlos</city>
        <state>São Paulo</state>
        <zip>13565-905</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 6, 2014</last_update_submitted>
  <last_update_submitted_qc>September 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
    <investigator_full_name>Anielle C M Takahashi</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cognition</keyword>
  <keyword>Functional capacity</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/NCT02235922
org study id: LAPESI-01
nct id: NCT02235922
lead sponsor: 
has dmc: Yes
The purpose of this study is to analyze the effects of a dual task protocol on cognitive
      domains and functional capacity in non-sedentary older adults.

      The hypothesis of the present study is that older people undergoing to a dual task exercise
      protocol have greater benefits on cognition and functional performance, compared to a
      standard exercise protocol.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes on cognition after 3 months of training
time frame: Assessed at baseline and after 3 months of training
description: Cognition was assessed by Montreal Cognitive Assessment and Mini-Mental State Examination
measure: Changes on functional capacity after 3 months of training
time frame: Assessed at baseline and after 3 months of training
description: Functional capacity was assessed by Timed up and go test, Timed up and go test associated to a cognitive task and sit to stand test.
arm group label: Dual task training
arm group type: Experimental
description: Dual task training
arm group label: Conventional training
arm group type: Experimental
description: Conventional training
intervention type: Other
intervention name: Dual task training
description: The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.
arm group label: Dual task training
intervention type: Other
intervention name: Conventional training
description: The conventional training consisted of individuals subjected to a multicomponent exercise program.
arm group label: Conventional training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anielle Takahashi, doctorate
role: Principal Investigator
affiliation: Universidade Federal de Sao Carlos
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Sao Carlos
investigator full name: Anielle C M Takahashi
investigator title: principal investigator