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/NCT05965518</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300011502</org_study_id>
      <nct_id>NCT05965518</nct_id>
    </id_info>
    <brief_title>High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Adults With HIV</brief_title>
    <official_title>A Pilot Trial of High-Intensity Exercise to Combat Vascular and Cognitive Dysfunction in Older Adults With HIV</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>Yes</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 is a single site, randomized exercise trial with individuals at least 50 years of age&#xD;
        living with HIV who experience suboptimal cognition. The overall goals of this proposal are&#xD;
        to determine whether 12 weeks of structured high-intensity interval training (HIIT) can&#xD;
        overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous&#xD;
        moderate exercise. Additionally, investigator will seek to identify barriers to engagement in&#xD;
        exercise and the participants' perceptions of the study and exercise interventions (Aim 2).&#xD;
        This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at&#xD;
        each visit, with baseline data collected at the initial visit with a 3-month follow-up&#xD;
        occurring following completion of the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single site, randomized exercise trial with individuals at least 50 years of age&#xD;
        living with HIV who experience suboptimal cognition. The overall goals of this proposal are&#xD;
        to determine whether 12 weeks of structured high-intensity interval training (HIIT) can&#xD;
        overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous&#xD;
        moderate exercise. Additionally, investigator will seek to identify barriers to engagement in&#xD;
        exercise and the participants' perceptions of the study and exercise interventions (Aim 2).&#xD;
        This study will enroll 60 participants in Birmingham, Alabama.&#xD;
  &#xD;
        Vascular function will be measured using pulse wave velocity. Cognition will be assessed&#xD;
        using the BRACE+. Additionally, perceptions of exercise and the study as well as barriers to&#xD;
        engaging in exercise will be determined through the analysis qualitative interviews.&#xD;
  &#xD;
        The overall hypothesis is that HIIT will result in greater enhancements in vascular and&#xD;
        cognitive function. The investigators expect that individuals randomized to HIIT will result&#xD;
        in greater satisfaction with the protocol. Based on the data collected, the investigators&#xD;
        seek to develop tailored intervention to promote successful aging among older people living&#xD;
        with HIV.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2027</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>
      <intervention_model_description>Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in vascular function</measure>
      <time_frame>Baseline, Up to 12 weeks, 3-months Post-Intervention</time_frame>
      <description>Arterial stiffness is a continuous measure of cardiovascular disease risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in cognitive function</measure>
      <time_frame>Baseline, Up to 12 weeks, 3-months Post-Intervention</time_frame>
      <description>Cognitive function will be measured using BRACE+, a neuropsychological battery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Barriers to Engagement in Exercise</measure>
      <time_frame>Baseline</time_frame>
      <description>This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceptions of the Study and Exercise Interventions</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Participant Safety, Adherence to the Intervention, Retention</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Participant safety will be assessed based on the number of adverse events which leads to termination of the exercise training. This will be registered as a binary outcome (yes/no). Adherence to the intervention will be measured based on the percentage of the exercise sessions that the participants attend. Retention at assessments will be measured by trial condition for each primary outcome assessment (e.g., immediately post-intervention and 3-months post-intervention). Participants will be considered retained if they complete the assessment visit in its entirety. It will be expressed as a percentage of participants with available outcome assessments immediately post-intervention and 3-months post-intervention).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>HIV</condition>
    <condition>Arterial Stiffness</condition>
    <condition>Cognitive Dysfunction</condition>
    <arm_group>
      <arm_group_label>High-Intensity Interval Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Continuous Moderate Exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>High-Intensity Interval Training</intervention_name>
      <description>Exercise will be done on the stationary bicycle. For the HIIT group, following a warm-up at 50% of heart rate reserve (HRR) higher- and lower-intensity exercise bouts will alternate: five bouts of 4-minute vigorous-intensity exercise (up to 90% HRR) with four 3-minute bouts of moderate-intensity aerobic exercise (50% HRR). Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 45 minutes for HIIT. The intensity of exercise will progress over the first 6 weeks to reach the target goals, and this prescription will be maintained until the end of the end of the interventions.</description>
      <arm_group_label>High-Intensity Interval Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Continuous Moderate Exercise</intervention_name>
      <description>Exercise will be done on the stationary bicycle. For the continuous-moderate exercise group, following a warm-up at 50% HRR, the participant will walk continuously at 60% HRR. HRR will be calculated using the supine resting heart rate and age-predicted max heart rate. Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 50 minutes for continuous-moderate exercise.</description>
      <arm_group_label>Continuous Moderate Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 50 years and older&#xD;
  &#xD;
            -  Sedentary lifestyle, deﬁned as &lt; 150 min/wk moderate physical activity as assessed by&#xD;
               CHAMPS questionnaire&#xD;
  &#xD;
            -  Neurocognitive Impairment (as assessed using the BRACE+&#xD;
  &#xD;
            -  Prescribed HIV ART for ≥ 12 months, with no current use of older drugs with&#xD;
               established mitochondrial toxicity&#xD;
  &#xD;
            -  Able to speak, read, and write in English&#xD;
  &#xD;
            -  Willingness to participate in all study procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of mitochondrial disease&#xD;
  &#xD;
            -  Active substance abuse or factors preventing compliance or safety&#xD;
  &#xD;
            -  Uncontrolled hypertension, deﬁned as resting BP &gt; 150/90 mmHG&#xD;
  &#xD;
            -  Chronic kidney disease&#xD;
  &#xD;
            -  Severe cardiac disease, including NYHA Class III or IV congestive heart failure,&#xD;
               clinically signiﬁcant aortic stenosis, history of cardiac arrest, use of a cardiac&#xD;
               deﬁbrillator, or uncontrolled angina&#xD;
  &#xD;
            -  Acute myocardial infarction identiﬁed by medical history and ECG&#xD;
  &#xD;
            -  Pulmonary disease requiring the use of supplemental oxygen&#xD;
  &#xD;
            -  Poorly controlled diabetes&#xD;
  &#xD;
            -  Neuropsychologically Intact&#xD;
  &#xD;
            -  Orthopedic problems that limit ability to perform exercise&#xD;
  &#xD;
            -  Simultaneous participation in another intervention trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Raymond Jones, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alabama at Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Raymond Jones, Ph.D.</last_name>
      <phone>205-996-3569</phone>
      <email>raymondjones@uabmc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Raymond Jones, Ph.D.</last_name>
        <phone>205-996-3569</phone>
        <email>raymondjones@uabmc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 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>Raymond Jones</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Participant-level deidentified data will be preserved through deposition of the data in a controlled public repository. All aggregate datasets that can be shared publicly will be deposited in the NIH/NIA Repository, National Archive of Computerized Data on Aging (NACDA).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will be made available no later than the time of an associated publication or end of the funding period, whichever comes first. NACDA guarantees data will be made available for ≥10 years</ipd_time_frame>
      <ipd_access_criteria>De-identified individual participant data will be deposited into NACDA as restricted, which limits access to the data to qualified investigators with who must sign a data use agreement. NACDA requires users to submit a data use agreement. NACDA will review the data request for completeness and determine if an IRB approval is needed. Anyone who has submitted an approved data request and signed data use agreement on NACDA will be given access to the data without cost, for a set period.</ipd_access_criteria>
    </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/NCT05965518
  org study id: IRB-300011502
  nct id: NCT05965518
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a single site, randomized exercise trial with individuals at least 50 years of age
        living with HIV who experience suboptimal cognition. The overall goals of this proposal are
        to determine whether 12 weeks of structured high-intensity interval training (HIIT) can
        overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous
        moderate exercise. Additionally, investigator will seek to identify barriers to engagement in
        exercise and the participants' perceptions of the study and exercise interventions (Aim 2).
        This study will enroll 60 participants in Birmingham, Alabama. Data collection will occur at
        each visit, with baseline data collected at the initial visit with a 3-month follow-up
        occurring following completion of the intervention.
  This is a single site, randomized exercise trial with individuals at least 50 years of age
        living with HIV who experience suboptimal cognition. The overall goals of this proposal are
        to determine whether 12 weeks of structured high-intensity interval training (HIIT) can
        overcome vascular and cognitive impairments (Aim 1) to a greater extent than continuous
        moderate exercise. Additionally, investigator will seek to identify barriers to engagement in
        exercise and the participants' perceptions of the study and exercise interventions (Aim 2).
        This study will enroll 60 participants in Birmingham, Alabama.
  
        Vascular function will be measured using pulse wave velocity. Cognition will be assessed
        using the BRACE+. Additionally, perceptions of exercise and the study as well as barriers to
        engaging in exercise will be determined through the analysis qualitative interviews.
  
        The overall hypothesis is that HIIT will result in greater enhancements in vascular and
        cognitive function. The investigators expect that individuals randomized to HIIT will result
        in greater satisfaction with the protocol. Based on the data collected, the investigators
        seek to develop tailored intervention to promote successful aging among older people living
        with HIV.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to high-intensity interval training or continuous moderate exercise for 12 weeks.
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in vascular function
  time frame: Baseline, Up to 12 weeks, 3-months Post-Intervention
  description: Arterial stiffness is a continuous measure of cardiovascular disease risk.
  measure: Change in cognitive function
  time frame: Baseline, Up to 12 weeks, 3-months Post-Intervention
  description: Cognitive function will be measured using BRACE+, a neuropsychological battery
  measure: Barriers to Engagement in Exercise
  time frame: Baseline
  description: This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.
  measure: Perceptions of the Study and Exercise Interventions
  time frame: Up to 12 weeks
  description: This will be assessed during qualitative interviews grounded in the Theoretical Domains Framework.
  measure: Participant Safety, Adherence to the Intervention, Retention
  time frame: Through study completion, an average of 6 months
  description: Participant safety will be assessed based on the number of adverse events which leads to termination of the exercise training. This will be registered as a binary outcome (yes/no). Adherence to the intervention will be measured based on the percentage of the exercise sessions that the participants attend. Retention at assessments will be measured by trial condition for each primary outcome assessment (e.g., immediately post-intervention and 3-months post-intervention). Participants will be considered retained if they complete the assessment visit in its entirety. It will be expressed as a percentage of participants with available outcome assessments immediately post-intervention and 3-months post-intervention).
  arm group label: High-Intensity Interval Training
  arm group type: Experimental
  arm group label: Continuous Moderate Exercise
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: High-Intensity Interval Training
  description: Exercise will be done on the stationary bicycle. For the HIIT group, following a warm-up at 50% of heart rate reserve (HRR) higher- and lower-intensity exercise bouts will alternate: five bouts of 4-minute vigorous-intensity exercise (up to 90% HRR) with four 3-minute bouts of moderate-intensity aerobic exercise (50% HRR). Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 45 minutes for HIIT. The intensity of exercise will progress over the first 6 weeks to reach the target goals, and this prescription will be maintained until the end of the end of the interventions.
  arm group label: High-Intensity Interval Training
  intervention type: Behavioral
  intervention name: Continuous Moderate Exercise
  description: Exercise will be done on the stationary bicycle. For the continuous-moderate exercise group, following a warm-up at 50% HRR, the participant will walk continuously at 60% HRR. HRR will be calculated using the supine resting heart rate and age-predicted max heart rate. Both groups will complete a comparable cool-down period. From weeks 6 to 12, the aerobic exercise duration will be 50 minutes for continuous-moderate exercise.
  arm group label: Continuous Moderate Exercise
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Raymond Jones, Ph.D.
  role: Principal Investigator
  affiliation: University of Alabama at Birmingham
  last name: Raymond Jones, Ph.D.
  phone: 205-996-3569
  email: raymondjones@uabmc.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Raymond Jones
  investigator title: Assistant Professor
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: Participant-level deidentified data will be preserved through deposition of the data in a controlled public repository. All aggregate datasets that can be shared publicly will be deposited in the NIH/NIA Repository, National Archive of Computerized Data on Aging (NACDA).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will be made available no later than the time of an associated publication or end of the funding period, whichever comes first. NACDA guarantees data will be made available for ≥10 years
  ipd access criteria: De-identified individual participant data will be deposited into NACDA as restricted, which limits access to the data to qualified investigators with who must sign a data use agreement. NACDA requires users to submit a data use agreement. NACDA will review the data request for completeness and determine if an IRB approval is needed. Anyone who has submitted an approved data request and signed data use agreement on NACDA will be given access to the data without cost, for a set period.