<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/NCT02994134</url>
  </required_header>
  <id_info>
    <org_study_id>20161059</org_study_id>
    <nct_id>NCT02994134</nct_id>
  </id_info>
  <brief_title>Exercise, Cognitive Function and Neuroplasticity in Healthy Adults</brief_title>
  <official_title>Exercise, Cognitive Function and Neuroplasticity in Healthy Adults</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>
      The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or&#xD;
      high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and&#xD;
      postural control in sedentary healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the study is to compare the effects of a moderate intensity aerobic&#xD;
      exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high&#xD;
      intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart&#xD;
      rate) on measures that probe cortical synaptic plasticity using transcranial magnetic&#xD;
      stimulation (TMS) in sedentary healthy adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
    <description>Plasticity with TMS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Moderate intensity exercise.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High intensity exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Moderate intensity exercise.</intervention_name>
    <description>Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.</description>
    <arm_group_label>Moderate intensity exercise.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity exercise.</intervention_name>
    <description>High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.</description>
    <arm_group_label>High intensity exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females aged 18-70 years old&#xD;
&#xD;
          -  Primary language is English&#xD;
&#xD;
          -  Sedentary (defined as not engaging in purposeful physical activity more than 2 times&#xD;
             over the last two months)&#xD;
&#xD;
          -  Exercise clearance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of cognitive, neurologic or orthopedic conditions that could affect&#xD;
             performance of the testing and training procedures&#xD;
&#xD;
          -  History of migraines.&#xD;
&#xD;
          -  History of fainting spells of unknown or undetermined etiology that might constitute&#xD;
             seizures&#xD;
&#xD;
          -  History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or&#xD;
             family history of treatment resistant epilepsy&#xD;
&#xD;
          -  Any current history of a psychiatric illness&#xD;
&#xD;
          -  Any unstable medical condition&#xD;
&#xD;
          -  No medication is an absolute exclusion from TMS. Medications will be reviewed by the&#xD;
             Principal Investigator and a decision about inclusion will be made based on the&#xD;
             following:&#xD;
&#xD;
               -  The subject's past medical history, drug dose, history of recent medication&#xD;
                  changes or duration of treatment, and combination with other CNS active drugs.&#xD;
&#xD;
               -  The published TMS guidelines review medications to be considered with TMS (Rossi,&#xD;
                  Hallett, Rossini, Pascual-Leone, &amp; Safety of TMS Consensus Group, 2009).&#xD;
&#xD;
          -  Any metal in the brain, skull or elsewhere unless approved by the responsible MD&#xD;
&#xD;
          -  Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication&#xD;
             infusion pump, cochlear implant, vagal nerve stimulator)&#xD;
&#xD;
          -  Intracranial lesion&#xD;
&#xD;
          -  Substance abuse or dependence within the past six months Subjects who, in the&#xD;
             Investigator's opinion, might not be suitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce R Gomes Osman, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Joyce Rios Gomes Osman</investigator_full_name>
    <investigator_title>Assistant 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/NCT02994134
org study id: 20161059
nct id: NCT02994134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or
      high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and
      postural control in sedentary healthy adults.
The primary aim of the study is to compare the effects of a moderate intensity aerobic
      exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high
      intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart
      rate) on measures that probe cortical synaptic plasticity using transcranial magnetic
      stimulation (TMS) in sedentary healthy adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.
time frame: Baseline, 4 weeks
description: Plasticity with TMS
arm group label: Moderate intensity exercise.
arm group type: Active Comparator
description: Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.
arm group label: High intensity exercise
arm group type: Experimental
description: High intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
intervention type: Behavioral
intervention name: Moderate intensity exercise.
description: Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.
arm group label: Moderate intensity exercise.
intervention type: Behavioral
intervention name: High intensity exercise.
description: High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
arm group label: High intensity exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joyce R Gomes Osman, PT, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Joyce Rios Gomes Osman
investigator title: Assistant Professor
sharing ipd: No