xml: <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/NCT06035094</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300011511</org_study_id>
      <secondary_id>2027708</secondary_id>
      <nct_id>NCT06035094</nct_id>
    </id_info>
    <brief_title>An Exercise Intervention to Improve Overall Brain Health</brief_title>
    <official_title>An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</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 clinical trial is to test the effects of 10 weeks of exercise on overall&#xD;
        brain health, reduction in blood pressure, and the number of blood vessels in the back of the&#xD;
        eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main&#xD;
        question[s] it aims to answer are:&#xD;
  &#xD;
          -  To test the effect of moderate vs intensive exercise on Brain Care Score outcomes.&#xD;
  &#xD;
          -  To ascertain the differential impact of moderate vs high intensity exercise in reducing&#xD;
             hypertension and its downstream effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Improved overall Brain Care Score metric.</measure>
      <time_frame>10 consecutive weeks of exercise training</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Brain Care Score, Exercise, Hypertension, BMI</condition>
    <arm_group>
      <arm_group_label>High Intensity Interval Training (HIIT) exercise group,</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate Intensity Training (MIT) exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control exercise group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise Intervention to improve overall Brain Health</intervention_name>
      <description>During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity &quot;zones&quot;. The participant will receive training on how to use the outlined schedule during the initial supervised training session.</description>
      <arm_group_label>Control exercise group</arm_group_label>
      <arm_group_label>High Intensity Interval Training (HIIT) exercise group,</arm_group_label>
      <arm_group_label>Moderate Intensity Training (MIT) exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with hypertension, have a body mass index ≥ 25 kg/m2, are between the ages&#xD;
               of 35-65 years old, access to a smart phone that allows installation of 2 two&#xD;
               applications that record your workouts, and pass a fitness evaluation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pamela G. Bowen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alabama at Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pamela G. Bowen, PhD</last_name>
      <phone>2054472343</phone>
      <email>pbowen@uab.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tasha Smith, PhD</last_name>
      <phone>2059348155</phone>
      <email>tasharsmith@uabmc.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>Pamela G Bowen PhD, CRNP, FNP-BC, BBA</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Brain health, brain care score. exercise. hypertension, overweight, obesity, BMI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035094
  org study id: IRB-300011511
  secondary id: 2027708
  nct id: NCT06035094
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall
        brain health, reduction in blood pressure, and the number of blood vessels in the back of the
        eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main
        question[s] it aims to answer are:
  
          -  To test the effect of moderate vs intensive exercise on Brain Care Score outcomes.
  
          -  To ascertain the differential impact of moderate vs high intensity exercise in reducing
             hypertension and its downstream effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Improved overall Brain Care Score metric.
  time frame: 10 consecutive weeks of exercise training
  arm group label: High Intensity Interval Training (HIIT) exercise group,
  arm group type: Experimental
  description: Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.
  arm group label: Moderate Intensity Training (MIT) exercise group
  arm group type: Experimental
  description: Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.
  arm group label: Control exercise group
  arm group type: Active Comparator
  description: Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.
  intervention type: Behavioral
  intervention name: Exercise Intervention to improve overall Brain Health
  description: During each exercise session, the participant will be assigned to the HIIT or MIT exercise group and asked to ride the stationary bicycle for approximately 30-40 minutes, while wearing the heart rate monitor and recording the session on their smart phone application. For each exercise session, the Polar Beat application will record the time in each of four intensity "zones". The participant will receive training on how to use the outlined schedule during the initial supervised training session.
  arm group label: Control exercise group
  arm group label: High Intensity Interval Training (HIIT) exercise group,
  arm group label: Moderate Intensity Training (MIT) exercise group
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pamela G. Bowen, PhD
  role: Principal Investigator
  affiliation: University of Alabama at Birmingham
  last name: Pamela G. Bowen, PhD
  phone: 2054472343
  email: pbowen@uab.edu
  last name: Tasha Smith, PhD
  phone: 2059348155
  email: tasharsmith@uabmc.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Pamela G Bowen PhD, CRNP, FNP-BC, BBA
  investigator title: Associate Professor
  mesh term: Hypertension
  sharing ipd: No