<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/NCT04417309</url>
  </required_header>
  <id_info>
    <org_study_id>58938</org_study_id>
    <nct_id>NCT04417309</nct_id>
  </id_info>
  <brief_title>Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder</brief_title>
  <acronym>PTSD</acronym>
  <official_title>Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Adams</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</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>
      This study aims to test whether aerobic exercise improves the consolidation and subsequent&#xD;
      recall of the learned safety memories among adult women with PTSD related to interpersonal&#xD;
      violence exposure and whether this effect is mediated by the ability of exercise to increase&#xD;
      acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB).&#xD;
      Participants can expect to be on study for up to 90 days, participating in 4 study sessions:&#xD;
      Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and&#xD;
      Exercise, and Day 4 of Recall of Emotional Learning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID-19 prevented recruitment/enrollment of participants.&#xD;
  </why_stopped>
  <start_date type="Actual">May 8, 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Actual">May 21, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant Skin Conductance Responding (SCR)</measure>
    <time_frame>up to Day 4</time_frame>
    <description>Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (skin conductance responses). SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Participants will be instructed to select an intensity of a 7/10 on the subjective pain scale, which should be &quot;uncomfortable, but not painful.&quot; Average intensity of participant skin conductance will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant Expectancy Ratings</measure>
    <time_frame>Up to day 4</time_frame>
    <description>Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (expectancy ratings). Expectancy will be assessed throughout each phase of the experiment to estimate the degree to which the subject believes she will receive a shock following presentation of certain pictures presented during the experiment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)</measure>
    <time_frame>before and after 30 min exercise on Day 3</time_frame>
    <description>Aim 2 group differences in BDNF consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is BDNF increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Group Differences in Serum Endocannabinoid (eCB) Content</measure>
    <time_frame>before and after 30 min exercise on Day 3</time_frame>
    <description>Aim 2 group differences in eCB consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is eCBs increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States (POMS) Questionnaire</measure>
    <time_frame>at each visit, up to Day 4</time_frame>
    <description>The POMS survey is a 65-item survey scored on a 5 point Likert Scale (0-4) where 0 s 'not at all' and 4 is 'extremely' for the tension, depression, fatigue, confusion, and anger subscales, and reversed for the vigor and esteem-related affect subscales. The range of total possible scores is XX-XX with higher numbers indicating more extreme or negative moods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>at each visit, up to Day 4</time_frame>
    <description>STAI is a 20-item assessment rated on a 4-point scale from 'almost never' to 'almost always' with the total scores ranging from 20-80. Higher scores indicate greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Positive and Negative Affect Scale (PANAS)</measure>
    <time_frame>at each visit, up to Day 4</time_frame>
    <description>PANAS is comprised of two 10-item scales for both positive and negative affect. Total combine scoring is from 20-100 where the higher the score the more negative the affect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>Moderate Intensity Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by moderate intensity exercise), Day 4 Recall of Fear Extinction&#xD;
Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by low intensity exercise), Day 4 Recall of Fear Extinction&#xD;
Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental</intervention_name>
    <description>Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes.</description>
    <arm_group_label>Moderate Intensity Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Control</intervention_name>
    <description>Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for 30 minutes.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of PTSD where the index traumatic event includes physical or sexual&#xD;
             assault&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Medically healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any endorsed medical concerns related to physical activity (as probed in the phone&#xD;
             screening questions regarding cardiovascular, pulmonary, or metabolic disease and as&#xD;
             assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into&#xD;
             participants' history of heart conditions, chest pain, dizziness, loss of&#xD;
             consciousness, bone/joint problems, and medication history). Participants would not be&#xD;
             excluded if they report this condition being &quot;controlled&quot; or &quot;addressed&quot; through&#xD;
             medication or lifestyle change, such as regular exercise.&#xD;
&#xD;
          -  Major medical disorders (such as cancer, AIDS)&#xD;
&#xD;
          -  Physical discomfort or difficulty with blood draws&#xD;
&#xD;
          -  Psychotic disorders&#xD;
&#xD;
          -  Intellectual disabilities&#xD;
&#xD;
          -  Developmental disorders&#xD;
&#xD;
          -  Active substance use disorders&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Due to safety concerns, participants with these conditions will be ineligible to&#xD;
             participate:&#xD;
&#xD;
          -  Major medical disorders (e.g., HIV, cancer)&#xD;
&#xD;
          -  Daily cannabis use&#xD;
&#xD;
          -  History of light headedness or fainting during blood draws or physical activity&#xD;
&#xD;
          -  History of chest pain during physical activity&#xD;
&#xD;
          -  Abnormal EKG finding at intake visit screening, without follow-up clearance from their&#xD;
             physician&#xD;
&#xD;
          -  Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be&#xD;
             worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD),&#xD;
             diabetes, hypertension) that is not currently addressed via medication or lifestyle&#xD;
             change.&#xD;
&#xD;
          -  A positive pregnancy test&#xD;
&#xD;
          -  A self-reported history of loss of consciousness (greater than 30 minutes)&#xD;
&#xD;
          -  Physical disabilities that prohibit task performance (such as blindness or deafness)&#xD;
&#xD;
          -  Psychotic disorders (e.g., schizophrenia)&#xD;
&#xD;
          -  Any other condition that the investigator believes might put the participant at risk&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas G Adams Jr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Thomas Adams</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Women, Exercise, Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT04417309
org study id: 58938
nct id: NCT04417309
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to test whether aerobic exercise improves the consolidation and subsequent
      recall of the learned safety memories among adult women with PTSD related to interpersonal
      violence exposure and whether this effect is mediated by the ability of exercise to increase
      acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB).
      Participants can expect to be on study for up to 90 days, participating in 4 study sessions:
      Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and
      Exercise, and Day 4 of Recall of Emotional Learning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participant Skin Conductance Responding (SCR)
time frame: up to Day 4
description: Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (skin conductance responses). SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Participants will be instructed to select an intensity of a 7/10 on the subjective pain scale, which should be "uncomfortable, but not painful." Average intensity of participant skin conductance will be reported.
measure: Participant Expectancy Ratings
time frame: Up to day 4
description: Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (expectancy ratings). Expectancy will be assessed throughout each phase of the experiment to estimate the degree to which the subject believes she will receive a shock following presentation of certain pictures presented during the experiment.
measure: Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)
time frame: before and after 30 min exercise on Day 3
description: Aim 2 group differences in BDNF consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is BDNF increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
measure: Group Differences in Serum Endocannabinoid (eCB) Content
time frame: before and after 30 min exercise on Day 3
description: Aim 2 group differences in eCB consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is eCBs increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
measure: Change in Profile of Mood States (POMS) Questionnaire
time frame: at each visit, up to Day 4
description: The POMS survey is a 65-item survey scored on a 5 point Likert Scale (0-4) where 0 s 'not at all' and 4 is 'extremely' for the tension, depression, fatigue, confusion, and anger subscales, and reversed for the vigor and esteem-related affect subscales. The range of total possible scores is XX-XX with higher numbers indicating more extreme or negative moods.
measure: Change in State-Trait Anxiety Inventory (STAI)
time frame: at each visit, up to Day 4
description: STAI is a 20-item assessment rated on a 4-point scale from 'almost never' to 'almost always' with the total scores ranging from 20-80. Higher scores indicate greater anxiety.
measure: Change in Positive and Negative Affect Scale (PANAS)
time frame: at each visit, up to Day 4
description: PANAS is comprised of two 10-item scales for both positive and negative affect. Total combine scoring is from 20-100 where the higher the score the more negative the affect.
arm group label: Moderate Intensity Exercise
arm group type: Experimental
description: Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by moderate intensity exercise), Day 4 Recall of Fear Extinction
Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction
arm group label: Control
arm group type: Active Comparator
description: Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by low intensity exercise), Day 4 Recall of Fear Extinction
Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction
intervention type: Behavioral
intervention name: Experimental
description: Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes.
arm group label: Moderate Intensity Exercise
intervention type: Behavioral
intervention name: Active Control
description: Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for 30 minutes.
arm group label: Control
criteria: 
gender: Female
gender based: Yes
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas G Adams Jr, PhD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Thomas Adams
investigator title: Assistant Professor
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No