<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/NCT03799640</url>
  </required_header>
  <id_info>
    <org_study_id>20180704</org_study_id>
    <nct_id>NCT03799640</nct_id>
  </id_info>
  <brief_title>Multidirectional Yoga for Cognition</brief_title>
  <official_title>Multidirectional Yoga Training to Improve in Healthy Older Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older individuals, 60-90, will be provided regular or cognitively based yoga training. They&#xD;
      will then be evaluated using standard cognitive testing devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reductions in executive function are common with age. Along with these declines come&#xD;
      reductions in simple functional patterns of daily living such as crossing a street, walking&#xD;
      in a crowded area, or performing any functions that occurs in an open (changing) environment.&#xD;
      This study will use a newly developed yoga program incorporating multi-directional movements,&#xD;
      cognitive challenges and visuomotor disturbances to improve executive function and associated&#xD;
      movements in persons over 60 years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2019</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>
    <intervention_model_description>Comparison of Yoga Interventions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Tests will not be performed by the investigators providing the interventions..</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>NIH Toolbox: Picture Sequence Memory Test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH Toolbox Flanker test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH Toolbox List Sorting test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measures working memory. Participant recalls and sequences different visually and orally presented stimuli.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH Toolbox Pattern Comparison Processing Speed test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Walking Executive Function Tests</measure>
    <time_frame>10 minutes</time_frame>
    <description>Walking and responding to visual cues presented on a 60 inch monitor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed up-and-go</measure>
    <time_frame>5 minutes</time_frame>
    <description>Rising from a chair, circumventing a cone and returning to the chair.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Standard Yoga</condition>
  <condition>Multi-directional Yoga</condition>
  <condition>Educational Control</condition>
  <arm_group>
    <arm_group_label>Standard Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga will be performed using linear forward and backward movements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multi-directional Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lectures on Health and Wellness</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Yoga</intervention_name>
    <description>Yoga using standard poses and linear movements</description>
    <arm_group_label>Educational Control</arm_group_label>
    <arm_group_label>Multi-directional Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multi-directional Yoga</intervention_name>
    <description>The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses.</description>
    <arm_group_label>Educational Control</arm_group_label>
    <arm_group_label>Standard Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Control</intervention_name>
    <description>Lectures on health and fitness</description>
    <arm_group_label>Multi-directional Yoga</arm_group_label>
    <arm_group_label>Standard Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60-90 years of age&#xD;
&#xD;
          -  Capable of walking 50 feet with or without a walking aid-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regularly participating in yoga or other balance training program&#xD;
&#xD;
          -  Currently participating in another exercise study&#xD;
&#xD;
          -  Unable to commit to study duration&#xD;
&#xD;
          -  Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an&#xD;
             exercise study&#xD;
&#xD;
          -  Advised not to exercise by their physician&#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>Joseph Signorile, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Max Orovitz Laboratories</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146-2416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratory of Neruomuscular Research and Active Aging</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Joseph Signorile</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03799640
org study id: 20180704
nct id: NCT03799640
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Older individuals, 60-90, will be provided regular or cognitively based yoga training. They
      will then be evaluated using standard cognitive testing devices.
Reductions in executive function are common with age. Along with these declines come
      reductions in simple functional patterns of daily living such as crossing a street, walking
      in a crowded area, or performing any functions that occurs in an open (changing) environment.
      This study will use a newly developed yoga program incorporating multi-directional movements,
      cognitive challenges and visuomotor disturbances to improve executive function and associated
      movements in persons over 60 years of age.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of Yoga Interventions
primary purpose: Treatment
masking: Single (Investigator)
masking description: Tests will not be performed by the investigators providing the interventions..
measure: NIH Toolbox: Picture Sequence Memory Test
time frame: 5 minutes
description: Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen.
measure: NIH Toolbox Flanker test
time frame: 5 minutes
description: Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it.
measure: NIH Toolbox List Sorting test
time frame: 5 minutes
description: Measures working memory. Participant recalls and sequences different visually and orally presented stimuli.
measure: NIH Toolbox Pattern Comparison Processing Speed test
time frame: 5 minutes
description: Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed.
measure: Walking Executive Function Tests
time frame: 10 minutes
description: Walking and responding to visual cues presented on a 60 inch monitor.
measure: Timed up-and-go
time frame: 5 minutes
description: Rising from a chair, circumventing a cone and returning to the chair.
arm group label: Standard Yoga
arm group type: Experimental
description: Yoga will be performed using linear forward and backward movements.
arm group label: Multi-directional Yoga
arm group type: Experimental
description: The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. .
arm group label: Educational Control
arm group type: Experimental
description: Lectures on Health and Wellness
intervention type: Other
intervention name: Standard Yoga
description: Yoga using standard poses and linear movements
arm group label: Educational Control
arm group label: Multi-directional Yoga
intervention type: Other
intervention name: Multi-directional Yoga
description: The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses.
arm group label: Educational Control
arm group label: Standard Yoga
intervention type: Other
intervention name: Educational Control
description: Lectures on health and fitness
arm group label: Multi-directional Yoga
arm group label: Standard Yoga
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Signorile, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Joseph Signorile
investigator title: Professor
sharing ipd: No