<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/NCT03804528</url>
  </required_header>
  <id_info>
    <org_study_id>20180926</org_study_id>
    <nct_id>NCT03804528</nct_id>
  </id_info>
  <brief_title>Cognition and Neuroplasticity Sedentary Adults After 8 Weeks of Aerobic Exercise</brief_title>
  <official_title>Assessing Cognitive Improvements, Brain Neuroplasticity and the Role of Genetic Factors After Aerobic Exercise in Sedentary 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 evaluate the effects of an 8-week aerobic&#xD;
      exercise program on cognition and determine the relationship between cognitive improvements&#xD;
      and Transcranial Magnetic Stimulation (TMS) neuroplasticity. The investigators will also&#xD;
      explore the effect modification of BDNF levels and BDNF allelic status, and APOE4 status on&#xD;
      cognitive response after exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will quantify cognitive improvements following moderate to high intensity&#xD;
      aerobic exercise intervention (participant will choose between treadmill, elliptical or&#xD;
      stationary bike). Each participant will engage in 60 minute daily sessions delivered 3&#xD;
      times/week for 8 consecutive weeks (a total of 24 sessions). The investigators will determine&#xD;
      the relationship between cognitive improvements and TMS neuroplasticity. The cognitive&#xD;
      domains explored will be: 1) Visuomotor processing speed and cognitive flexibility/task&#xD;
      switching; 2) Response inhibition, mental flexibility, and attentional control; 3) Attention&#xD;
      and working memory; 4) List Learning and Memory; and 5) Semantic Verbal Fluency. The&#xD;
      investigators will also explore the effect modification of BDNF levels and BDNF allelic&#xD;
      status, and APOE4 status on cognitive response after exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The intervention group will perform 4-weeks of moderate intensity exercise followed by 4-weeks of high intensity aerobic exercise.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in TMS Plasticity Measures</measure>
    <time_frame>baseline and after 8 weeks of exercise</time_frame>
    <description>An index of the duration of the Theta-Burst Stimulation (TBS) induced modulation of corticospinal excitability (the time-point at which the normalized mean Motor Evoked Potential (MEP) amplitude returns to baseline values) will be defined for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cognitive Performance</measure>
    <time_frame>baseline and after 8 weeks of exercise</time_frame>
    <description>Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in BDNF Levels</measure>
    <time_frame>baseline and after 8 weeks of exercise</time_frame>
    <description>Blood samples will be collected for BDNF levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aerobic Capacity (Cardiovascular Fitness)</measure>
    <time_frame>baseline and after 8 weeks of exercise</time_frame>
    <description>A maximal treadmill test will be performed to determine maximal oxygen uptake (VO2) as a measure of aerobic capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allelic Status BDNF</measure>
    <time_frame>baseline</time_frame>
    <description>Genetic testing will be performed to assess for brain-derived neurotrophic factor (BDNF) Val66Met polymorphism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allelic Status APOE</measure>
    <time_frame>baseline</time_frame>
    <description>Genetic testing will be performed to assess for the presence of apolipoprotein-E (APOE) e4 allele.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Sedentary Behavior</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will engage in 60 minute daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session.</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 55years&#xD;
&#xD;
          -  no clinically detectable cognitive impairment (MoCA score ≥ 24 and Clinical Dementia&#xD;
             Rating (CDR) score of 0)&#xD;
&#xD;
          -  low activity level (individuals who do not engage in regular exercise, or currently&#xD;
             exercise once a week or less)&#xD;
&#xD;
          -  primary language is English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any unstable medical condition (i.e.: uncontrolled hypertension or uncontrolled&#xD;
             diabetes)&#xD;
&#xD;
          -  medical contraindication to physical exercise&#xD;
&#xD;
          -  contraindication to TMS Neuroplasticity testing, as per the TMS Safety Guidelines.&#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;
          -  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 changes or&#xD;
             duration of treatment, and combination with other Central Nervous System (CNS) active&#xD;
             drugs.&#xD;
&#xD;
          -  The published TMS guidelines review medications to be considered with TMS.&#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&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Vulnerable populations such as prisoner's&#xD;
&#xD;
          -  People unable to consent themselves&#xD;
&#xD;
          -  Subjects who, in the Investigator's opinion might not be suitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</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>August 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 29, 2022</last_update_submitted>
  <last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</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/NCT03804528
org study id: 20180926
nct id: NCT03804528
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of the proposed study is to evaluate the effects of an 8-week aerobic
      exercise program on cognition and determine the relationship between cognitive improvements
      and Transcranial Magnetic Stimulation (TMS) neuroplasticity. The investigators will also
      explore the effect modification of BDNF levels and BDNF allelic status, and APOE4 status on
      cognitive response after exercise.
The investigators will quantify cognitive improvements following moderate to high intensity
      aerobic exercise intervention (participant will choose between treadmill, elliptical or
      stationary bike). Each participant will engage in 60 minute daily sessions delivered 3
      times/week for 8 consecutive weeks (a total of 24 sessions). The investigators will determine
      the relationship between cognitive improvements and TMS neuroplasticity. The cognitive
      domains explored will be: 1) Visuomotor processing speed and cognitive flexibility/task
      switching; 2) Response inhibition, mental flexibility, and attentional control; 3) Attention
      and working memory; 4) List Learning and Memory; and 5) Semantic Verbal Fluency. The
      investigators will also explore the effect modification of BDNF levels and BDNF allelic
      status, and APOE4 status on cognitive response after exercise.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The intervention group will perform 4-weeks of moderate intensity exercise followed by 4-weeks of high intensity aerobic exercise.
primary purpose: Other
masking: None (Open Label)
measure: Change in TMS Plasticity Measures
time frame: baseline and after 8 weeks of exercise
description: An index of the duration of the Theta-Burst Stimulation (TBS) induced modulation of corticospinal excitability (the time-point at which the normalized mean Motor Evoked Potential (MEP) amplitude returns to baseline values) will be defined for each participant.
measure: Change in Cognitive Performance
time frame: baseline and after 8 weeks of exercise
description: Cognitive performance will be assessed using a neuropsychological test battery in executive function, processing speed, learning, and language.
measure: Changes in BDNF Levels
time frame: baseline and after 8 weeks of exercise
description: Blood samples will be collected for BDNF levels.
measure: Change in Aerobic Capacity (Cardiovascular Fitness)
time frame: baseline and after 8 weeks of exercise
description: A maximal treadmill test will be performed to determine maximal oxygen uptake (VO2) as a measure of aerobic capacity.
measure: Allelic Status BDNF
time frame: baseline
description: Genetic testing will be performed to assess for brain-derived neurotrophic factor (BDNF) Val66Met polymorphism.
measure: Allelic Status APOE
time frame: baseline
description: Genetic testing will be performed to assess for the presence of apolipoprotein-E (APOE) e4 allele.
arm group label: Exercise group
arm group type: Experimental
description: Each participant will engage in 60 minute daily sessions delivered 3 times/week for 8 consecutive weeks (a total of 24 sessions).
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session.
arm group label: Exercise group
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
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