<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/NCT03036371</url>
  </required_header>
  <id_info>
    <org_study_id>7418</org_study_id>
    <nct_id>NCT03036371</nct_id>
  </id_info>
  <brief_title>Pilot Study of the Impact of Exercise on Hippocampal Function</brief_title>
  <official_title>Pilot Study of the Impact of Exercise on Hippocampal Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>New York State Psychiatric Institute</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 goal of this pilot study is to test the procedural aspects of the behavioral tests and&#xD;
      the exercise components of the study. This includes establishing typical scores for anxiety&#xD;
      patients in these behavioral tests, and administering and coaching anxiety patients in an&#xD;
      at-home exercise regimen. This pilot study will produce the information necessary to design a&#xD;
      larger future study including both patients and healthy control participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to explore whether High Intensity Interval Training (HIIT) aerobic&#xD;
      exercise can improve performance on hippocampal dependent behaviors or anxiety measures .&#xD;
      HIIT is a form of interval training that alternates short periods of high effort exercise&#xD;
      with less intense recovery periods. Participants in this study will undertake a 6-week&#xD;
      protocol of HIIT exercise, performed at home on a portable stepper device. Outcome measures&#xD;
      for this study will be performance on two hippocampus-dependent behaviors and responses to&#xD;
      mood and anxiety questionnaires.&#xD;
&#xD;
      The hippocampus is a brain structure that is involved in learning and memory, and is one of&#xD;
      the two sites of adult neurogenesis, the process of generating of new neurons from stem cells&#xD;
      in the adult mammalian brain. Adult neurogenesis may represent a new target for the treatment&#xD;
      of anxiety disorders. The tests in this study consist of a picture-based memory task and a&#xD;
      location memory task. Eligible participants will complete both game tasks. In each test,&#xD;
      participants will sit in front of a computer and play these games using the computer keyboard&#xD;
      or a handheld video game controller.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Actual">September 13, 2018</completion_date>
  <primary_completion_date type="Actual">September 13, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Percent Correct Score for the Treasure Hunt Task (THT)</measure>
    <time_frame>6 weeks</time_frame>
    <description>change between baseline and 6 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Percent Correct Score for the Mnemonic Similarity Test (MST)</measure>
    <time_frame>6 weeks</time_frame>
    <description>change between baseline and 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression, Anxiety, and Stress Scale (DASS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>change in self-report questionnaire score between baseline and 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intolerance of Uncertainty Scale (IUS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>change in self-report questionnaire score between baseline and 6 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baecke Physical Activity Questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>change in self-report questionnaire score between baseline and 6 weeks</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>home exercise sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Intensity Interval Exercise</intervention_name>
    <description>6 week at-home aerobic exercise protocol</description>
    <arm_group_label>High Intensity Interval Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A primary diagnosis of Obsessive Compulsive Disorder (OCD), Social Anxiety Disorder&#xD;
             (SAD), Generalized Anxiety Disorder (GAD), Panic Disorder (PD), and/or Specific Phobia&#xD;
             (SP)&#xD;
&#xD;
          -  No use of psychiatric medication in the past 4 weeks (or 8 weeks for fluoxetine)&#xD;
&#xD;
          -  Age 18-40&#xD;
&#xD;
          -  Ability to tolerate a treatment-free period&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Body Mass Index (BMI) within normal range&#xD;
&#xD;
          -  Willing and able to sign consent form and comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or lifetime comorbid psychiatric conditions that significantly elevate the&#xD;
             risk of study participation&#xD;
&#xD;
          -  Any major medical or neurological problem that might interfere with reliable&#xD;
             performance of study tasks or their interpretation, or render participation dangerous&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Use of medication that alters the brain&#xD;
&#xD;
          -  Clinical symptom severity warranting immediate treatment&#xD;
&#xD;
          -  Current rigorous exercise program&#xD;
&#xD;
          -  Participation in Cognitive Behavioral Therapy (CBT) psychotherapy for anxiety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen B Simpson, M.D, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Helen Blair Simpson</investigator_full_name>
    <investigator_title>Professor of Clinical Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Neurogenesis</keyword>
  <keyword>Memory</keyword>
  <keyword>Spatial Processing</keyword>
  <keyword>Hippocampus</keyword>
  <keyword>Cognition</keyword>
  <keyword>Aerobic Exercise</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a pilot study intended to assess the feasibility of an at-home exercise protocol in a patient population, and to measure within-patient changes from baseline to post-exercise in order to calculate sample sizes needed for a full study. Therefore, the investigators do not plan to share the data of this small pilot study with other researchers.</ipd_description>
  </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/NCT03036371
org study id: 7418
nct id: NCT03036371
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this pilot study is to test the procedural aspects of the behavioral tests and
      the exercise components of the study. This includes establishing typical scores for anxiety
      patients in these behavioral tests, and administering and coaching anxiety patients in an
      at-home exercise regimen. This pilot study will produce the information necessary to design a
      larger future study including both patients and healthy control participants.
This is a pilot study to explore whether High Intensity Interval Training (HIIT) aerobic
      exercise can improve performance on hippocampal dependent behaviors or anxiety measures .
      HIIT is a form of interval training that alternates short periods of high effort exercise
      with less intense recovery periods. Participants in this study will undertake a 6-week
      protocol of HIIT exercise, performed at home on a portable stepper device. Outcome measures
      for this study will be performance on two hippocampus-dependent behaviors and responses to
      mood and anxiety questionnaires.

      The hippocampus is a brain structure that is involved in learning and memory, and is one of
      the two sites of adult neurogenesis, the process of generating of new neurons from stem cells
      in the adult mammalian brain. Adult neurogenesis may represent a new target for the treatment
      of anxiety disorders. The tests in this study consist of a picture-based memory task and a
      location memory task. Eligible participants will complete both game tasks. In each test,
      participants will sit in front of a computer and play these games using the computer keyboard
      or a handheld video game controller.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Percent Correct Score for the Treasure Hunt Task (THT)
time frame: 6 weeks
description: change between baseline and 6 weeks
measure: Change in Percent Correct Score for the Mnemonic Similarity Test (MST)
time frame: 6 weeks
description: change between baseline and 6 weeks
measure: Change in Depression, Anxiety, and Stress Scale (DASS)
time frame: 6 weeks
description: change in self-report questionnaire score between baseline and 6 weeks
measure: Change in Intolerance of Uncertainty Scale (IUS)
time frame: 6 weeks
description: change in self-report questionnaire score between baseline and 6 weeks
measure: Change in Baecke Physical Activity Questionnaire
time frame: 6 weeks
description: change in self-report questionnaire score between baseline and 6 weeks
arm group label: High Intensity Interval Exercise
arm group type: Experimental
description: home exercise sessions
intervention type: Behavioral
intervention name: High Intensity Interval Exercise
description: 6 week at-home aerobic exercise protocol
arm group label: High Intensity Interval Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Helen B Simpson, M.D, Ph.D.
role: Principal Investigator
affiliation: New York State Psychiatric Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Helen Blair Simpson
investigator title: Professor of Clinical Psychiatry
sharing ipd: No
ipd description: This is a pilot study intended to assess the feasibility of an at-home exercise protocol in a patient population, and to measure within-patient changes from baseline to post-exercise in order to calculate sample sizes needed for a full study. Therefore, the investigators do not plan to share the data of this small pilot study with other researchers.