<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/NCT04504643</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A03263-54</org_study_id>
    <nct_id>NCT04504643</nct_id>
  </id_info>
  <brief_title>Comparison of Three Motor-cognitive Training Programs</brief_title>
  <acronym>EXECO</acronym>
  <official_title>Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aix Marseille Université</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aix Marseille Université</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>
      Understanding how to delay age-related physical and mental declines is an issue for aging&#xD;
      research. It has been shown that isolated aerobic, coordination and cognitive training&#xD;
      improve brain functions and cognitive performances. Moreover, the combination of them leads&#xD;
      to greater effects. Different combination modalities are possible: training programs&#xD;
      demanding cognitive resources within the activity performed in a natural environment like&#xD;
      Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training&#xD;
      where training components are systematically combined and their intensity controlled. The aim&#xD;
      of this study is to compare three training programs: a Nordic walking one (NW), and two&#xD;
      conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT)&#xD;
      exercises, while CT-fit characterized by cognitive charge embodied in the movements through&#xD;
      the use of technology. An improvement in physical, motor, and cognitive functions is expected&#xD;
      by all three groups. However, our primary hypothesis is that the CT-fit will impact executive&#xD;
      functions more.&#xD;
&#xD;
      45 healthy independent living community dwellers participants aged 65 to 80 will be&#xD;
      recruited. Participants will be included after a general medical examination (geriatric&#xD;
      screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of&#xD;
      cognitive impairment, (MMSE &lt;26/30), and physical impairments. Participants will be randomly&#xD;
      divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour&#xD;
      3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task,&#xD;
      Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities&#xD;
      through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance&#xD;
      test, walking speed and size of the base of support, Timed Up &amp; Go, Chair sit and reach test&#xD;
      and Four square stepping test) and physical assessment (10 m incremental shuttle walking&#xD;
      test, maximal handgrip force, 30s chair rise stand).&#xD;
&#xD;
      Improving cognitive functions by adding new technology embodied in a systematically combined&#xD;
      training (exergame), would result to be the best solution to optimize training for aging&#xD;
      people.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in working memory function through HappyNeuron Software</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for changing in working memory function tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in inhibition processes through Stroop task test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for changing of inhibition processes tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for changing of switching capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in visuospatial capacities through Rey complex Figure copy task</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for changing of visuospatial capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for chainging for dual task capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in global cognition capacity through the Moca test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for changing for general cognition tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for balance using a force platform for the bipedal upright standing (AMTI, Advanced Mechanical Technology, Inc., MA, USA). Both assessments tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gait pattern assessment</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment to test gait pattern using a Gait rite (walking at usual speed on a gait rite - GAITRite system, CIR Systems, Havertown, PA, United States) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional mobility through the Timed Up &amp; Go test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for functional mobility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes for flexibility through the Chair-sit and reach test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for functional flexibility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in motor coordination through the Four- Square Stepping test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for functional motor coordination tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in muscular strength through Maximal handgrip force test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for muscular strength (using JAMAR® hand dynamometer) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiovascular capacities through Shuttle walk test</measure>
    <time_frame>Through study completion, an average of 9 months</time_frame>
    <description>Assessment for cardiovascular capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Technology-assisted circuit training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multicomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional circuit training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multicomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nordic Walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Technology-assisted circuit training</intervention_name>
    <description>Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks</description>
    <arm_group_label>Technology-assisted circuit training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional circuit training</intervention_name>
    <description>Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks</description>
    <arm_group_label>Conventional circuit training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nordic walking</intervention_name>
    <description>Classic nordic walking 3 times a week for one hour during 8 weeks</description>
    <arm_group_label>Nordic Walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Considered apt for moderate physical activity practice (validated by a maximal VO2&#xD;
             cycle-ergometer test by a cardiologist)&#xD;
&#xD;
          -  Sedentary or moderately active (objectified by the categories obtained at the IPAQ)&#xD;
&#xD;
          -  Cognitively healthy (objectified by a score at the MMSE of 26 and above)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Colorblindness&#xD;
&#xD;
          -  Uncorrected earing and/or visual impairment&#xD;
&#xD;
          -  Presence of a known psychiatric or neurologic condition&#xD;
&#xD;
          -  Under psychotropic treatment or beta-blockers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Jacques Temprado, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aix Marseille Université</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Jacques Temprado, Ph.D.</last_name>
    <phone>+33 4 91 17 22 55</phone>
    <email>jean-jacques.temprado@univ-amu.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Jean-Jacques Temprado, Ph.D.</last_name>
      <phone>+33 4 91 17 22 55</phone>
      <email>jean-jacques.temprado@univ-amu.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aix Marseille Université</investigator_affiliation>
    <investigator_full_name>Jean-Jacques TEMPRADO</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>aging, cognition, cognitive-motor training, Nordic walking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <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/NCT04504643
org study id: 2019-A03263-54
nct id: NCT04504643
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Understanding how to delay age-related physical and mental declines is an issue for aging
      research. It has been shown that isolated aerobic, coordination and cognitive training
      improve brain functions and cognitive performances. Moreover, the combination of them leads
      to greater effects. Different combination modalities are possible: training programs
      demanding cognitive resources within the activity performed in a natural environment like
      Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training
      where training components are systematically combined and their intensity controlled. The aim
      of this study is to compare three training programs: a Nordic walking one (NW), and two
      conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT)
      exercises, while CT-fit characterized by cognitive charge embodied in the movements through
      the use of technology. An improvement in physical, motor, and cognitive functions is expected
      by all three groups. However, our primary hypothesis is that the CT-fit will impact executive
      functions more.

      45 healthy independent living community dwellers participants aged 65 to 80 will be
      recruited. Participants will be included after a general medical examination (geriatric
      screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of
      cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly
      divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour
      3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task,
      Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities
      through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance
      test, walking speed and size of the base of support, Timed Up & Go, Chair sit and reach test
      and Four square stepping test) and physical assessment (10 m incremental shuttle walking
      test, maximal handgrip force, 30s chair rise stand).

      Improving cognitive functions by adding new technology embodied in a systematically combined
      training (exergame), would result to be the best solution to optimize training for aging
      people.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Changes in working memory function through HappyNeuron Software
time frame: Through study completion, an average of 9 months
description: Assessment for changing in working memory function tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in inhibition processes through Stroop task test
time frame: Through study completion, an average of 9 months
description: Assessment for changing of inhibition processes tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in switching capacities through Trial Making Test part A and part B (TMT-A and TMT-B)
time frame: Through study completion, an average of 9 months
description: Assessment for changing of switching capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in visuospatial capacities through Rey complex Figure copy task
time frame: Through study completion, an average of 9 months
description: Assessment for changing of visuospatial capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in dual task capacities through Walking Oral Trail Making Test part A and part B (OTMT-A and OTMT-B)
time frame: Through study completion, an average of 9 months
description: Assessment for chainging for dual task capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in global cognition capacity through the Moca test
time frame: Through study completion, an average of 9 months
description: Assessment for changing for general cognition tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in balance capacities through Bipedal upright standing and Unipedal leg stance tests
time frame: Through study completion, an average of 9 months
description: Assessment for balance using a force platform for the bipedal upright standing (AMTI, Advanced Mechanical Technology, Inc., MA, USA). Both assessments tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in Gait pattern assessment
time frame: Through study completion, an average of 9 months
description: Assessment to test gait pattern using a Gait rite (walking at usual speed on a gait rite - GAITRite system, CIR Systems, Havertown, PA, United States) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in functional mobility through the Timed Up & Go test
time frame: Through study completion, an average of 9 months
description: Assessment for functional mobility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes for flexibility through the Chair-sit and reach test
time frame: Through study completion, an average of 9 months
description: Assessment for functional flexibility tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in motor coordination through the Four- Square Stepping test
time frame: Through study completion, an average of 9 months
description: Assessment for functional motor coordination tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in muscular strength through Maximal handgrip force test
time frame: Through study completion, an average of 9 months
description: Assessment for muscular strength (using JAMAR® hand dynamometer) tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
measure: Changes in cardiovascular capacities through Shuttle walk test
time frame: Through study completion, an average of 9 months
description: Assessment for cardiovascular capacities tested within the 4 weeks before the intervention (8 weeks of duration) and within the 4 weeks after the intervention ended. Up to 5 months for the results analysis and manuscript writing.
arm group label: Technology-assisted circuit training
arm group type: Experimental
description: Multicomponent circuit training using FItLight Trainer™ as an embodied tool to perform motor task. The circuit training is composed by aerobic, muscular, coordination and balance exercises.
arm group label: Conventional circuit training
arm group type: Experimental
description: Multicomponent circuit training composed by aerobic, muscular, balance and coordination exercises. Coordination exercises wll be charged of simple dual task cognitive exercises (counting backwards, or making some easy math calculations, repeating words backward, finding words of the same family).
arm group label: Nordic Walking
arm group type: Experimental
description: The training sessions are performed in a natural parc, which offers pathways of different lengths and levels of difficulty that will increase over the weeks.
intervention type: Other
intervention name: Technology-assisted circuit training
description: Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
arm group label: Technology-assisted circuit training
intervention type: Other
intervention name: Conventional circuit training
description: Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
arm group label: Conventional circuit training
intervention type: Other
intervention name: Nordic walking
description: Classic nordic walking 3 times a week for one hour during 8 weeks
arm group label: Nordic Walking
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Jacques Temprado, Ph.D.
role: Principal Investigator
affiliation: Aix Marseille Université
last name: Jean-Jacques Temprado, Ph.D.
phone: +33 4 91 17 22 55
email: jean-jacques.temprado@univ-amu.fr
facility: 
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Aix Marseille Université
investigator full name: Jean-Jacques TEMPRADO
investigator title: Professor
mesh term: Cognitive Dysfunction
sharing ipd: No