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/NCT06013579</url>
    </required_header>
    <id_info>
      <org_study_id>1R01AG077997-01A1</org_study_id>
      <secondary_id>1R01AG077997-01A1</secondary_id>
      <nct_id>NCT06013579</nct_id>
    </id_info>
    <brief_title>Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV</brief_title>
    <acronym>HEALTH-COG</acronym>
    <official_title>Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </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>
        People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and&#xD;
        although physical activity is a promising target to mitigate such risk, this population&#xD;
        engages in low levels of physical activity. Few studies have tested cognitive effects of&#xD;
        exercise interventions or examined mechanisms of adherence to long-term exercise among&#xD;
        diverse samples of midlife and older people with HIV. The current study will leverage an&#xD;
        existing R01 to address these gaps and provide implications for development of personalized&#xD;
        approaches for the treatment and prevention of cognitive impairment and dementia in older&#xD;
        people with HIV.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's&#xD;
        disease and related dementias (ADRD) than seronegative counterparts. Although physical&#xD;
        activity (PA) is a promising protective factor to mitigate ADRD risk, few well-powered PA&#xD;
        intervention studies have rigorously tested cognitive outcomes among older PWH, a population&#xD;
        with rates of moderate to vigorous PA well below recommended guidelines. Further, given that&#xD;
        adherence to habitual PA diminishes after supervised interventions, identifying mechanisms of&#xD;
        adherence (MoA) to habitual PA among older PWH is germane to develop effective and durable&#xD;
        interventions to protect cognitive health. The proposed R01 will leverage the High-Intensity&#xD;
        Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), a&#xD;
        two-site RCT (University of Washington [UW], University of Colorado Denver [UCD]) of 100&#xD;
        older PWH examining: 1) if 4 months of supervised high-intensity interval training (HIIT)&#xD;
        mitigates physical function impairments and fatigue to a greater extent than continuous&#xD;
        moderate exercise (CME); 2) the effects of a 3 month text-messaging intervention on PA&#xD;
        adherence. In contrast to CME, where aerobic exercise is performed continuously for a&#xD;
        specified duration, HIIT, which uses repeated alternating bouts of highintensity and lower&#xD;
        intensity aerobic exercise, has shown superior efficacy in improving physiological and&#xD;
        cognitive outcomes, and is associated with superior enjoyment which may increase adherence to&#xD;
        PA regimens. The proposed R01 (HEALTH-COG) will leverage the two HEALTH sites, add a new&#xD;
        racially diverse UAB site, and add new measures (psychological MoA measures, cognitive&#xD;
        function assessments, biomarkers) and a few 12 month follow-up to the parent study. We&#xD;
        estimate that of our planned sample of N=100, n=50 will be enrolled at UAB and n=50 total at&#xD;
        UW and UCD. Our primary aim is to compare the effects of a 4 month supervised HIIT or CME&#xD;
        intervention on (1°) cognitive functioning and (2°) subjective cognitive symptoms. Our&#xD;
        exploratory aim is to evaluate putative biomarkers underlying the effect of PA on cognition&#xD;
        (blood markers: e.g., BDNF, VEGF, IL-6 and neuroimaging markers: cerebral blood flow, resting&#xD;
        state functional connectivity, and brain volume). Our secondary aim is to determine MoA to&#xD;
        long-term PA maintenance at 12 months. This aim will examine distal predictors of long-term&#xD;
        PA, including sociodemographic, clinical, and intervention factors (i.e., changes in parent&#xD;
        R01 physical outcomes [cardiorespiratory fitness], condition [HIIT vs CME], [coaching vs&#xD;
        control]), as well as proximal psychological MoA assessed in real-time, using EMA (e.g.,&#xD;
        self-efficacy, perceived benefits, motivation, social support). Testing efficacy and&#xD;
        mechanisms of exercise interventions on cognitive outcomes and understanding psychological&#xD;
        MoA of habitual PA following supervised interventions will aid in the development and&#xD;
        implementation of personalized medicine approaches for the treatment and prevention of&#xD;
        cognitive impairment and ADRD in older PWH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2028</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>Baseline visit</time_frame>
      <description>Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>4 month follow-up visit</time_frame>
      <description>Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>7 month follow-up visit</time_frame>
      <description>Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>12 month follow-up visit</time_frame>
      <description>Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Psychological Mechanisms of Adherence</measure>
      <time_frame>12 month follow-up visit</time_frame>
      <description>Measures of mechanisms of adherence include self-efficacy, motivation, self-regulation strategies, outcome expectations, affective states, and social cohesion and support via in-person surveys and interviews.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>HIV Infections</condition>
    <condition>Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Continuous Moderate Exercise (CME)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High-Intensity Interval Training (HIIT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phase 1 Gym Exercise HIIT</intervention_name>
      <description>Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.</description>
      <arm_group_label>High-Intensity Interval Training (HIIT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phase 1 Gym Exercise CME</intervention_name>
      <description>Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.</description>
      <arm_group_label>Continuous Moderate Exercise (CME)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phase 2 Home Exercise Coaching Text Messages</intervention_name>
      <description>The coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.</description>
      <arm_group_label>Continuous Moderate Exercise (CME)</arm_group_label>
      <arm_group_label>High-Intensity Interval Training (HIIT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phase 2 Home Exercise Control Text Messages</intervention_name>
      <description>The control group will receive general daily texts from the study team (i.e., &quot;Hope you are doing well!&quot;), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.</description>
      <arm_group_label>Continuous Moderate Exercise (CME)</arm_group_label>
      <arm_group_label>High-Intensity Interval Training (HIIT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed HIV&#xD;
  &#xD;
            -  Sedentary lifestyle, defined as self-reported PA that breaks a sweat &lt;3 days/week,&#xD;
               with no regular resistance exercise for 3 months preceding study;&#xD;
  &#xD;
            -  Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue&#xD;
               Scale)&#xD;
  &#xD;
            -  On a current, contemporary ART regimen for &gt;=12 months;&#xD;
  &#xD;
            -  HIV-1 RNA &lt;200 copies/mL in the past 12 months (assessed via medical records)&#xD;
  &#xD;
            -  Willing to engage in a supervised exercise program 3 times/week for 4 months&#xD;
  &#xD;
            -  Cell phone or email to accept messages&#xD;
  &#xD;
            -  Weight &lt;450 lbs&#xD;
  &#xD;
            -  Medical clearance by study healthcare professional&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Weight over 450 pounds&#xD;
  &#xD;
            -  Use of sex hormone therapy, if on for ≤3 months (stable doses for &gt;3 months will be&#xD;
               permitted)&#xD;
  &#xD;
            -  Use of other hormone replacement, if on for ≤ 3 months (stable doses &gt;3 months will be&#xD;
               permitted)&#xD;
  &#xD;
            -  Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to&#xD;
               fatigue,&#xD;
  &#xD;
            -  Diagnosis of mitochondrial disease,&#xD;
  &#xD;
            -  Active substance abuse or other factors that could prevent compliance or safety with&#xD;
               study visits, at the discretion of the site investigator,&#xD;
  &#xD;
            -  Reasons for medical exclusion, as determined by Nurse Practioner:&#xD;
  &#xD;
                 1. Uncontrolled hypertension defined as resting systolic blood pressure &gt;150 mmHg or&#xD;
                    diastolic blood pressure &gt;90 mmHg; participants who do not meet these criteria at&#xD;
                    first screening will be reevaluated, including follow-up evaluation by their&#xD;
                    primary care provider with initiation or adjustment of anti-hypertensive&#xD;
                    medications,&#xD;
  &#xD;
                 2. Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious&#xD;
                    arrhythmias at rest or during the graded exercise test without negative follow-up&#xD;
                    evaluation will be cause for exclusion; follow-up evaluation must include&#xD;
                    diagnostic testing (e.g., thallium stress test) with interpretation by a&#xD;
                    cardiologist,&#xD;
  &#xD;
                 3. New York Heart Association Class III or IV congestive heart failure, clinically&#xD;
                    significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,&#xD;
  &#xD;
                 4. Pulmonary disease requiring the use of supplemental oxygen at rest or with&#xD;
                    physical exertion,&#xD;
  &#xD;
                 5. Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to&#xD;
                    enrollment,&#xD;
  &#xD;
                 6. Poorly controlled diabetes, as evidenced by hemoglobin A1c &gt; 8.5, documented&#xD;
                    within 6 months of study visit or current use of insulin,&#xD;
  &#xD;
                 7. Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the&#xD;
                    opinion of the study clinician, may impact a subject's baseline functional&#xD;
                    testing and ability to exercise,&#xD;
  &#xD;
                 8. Balance impairments that may impact functional testing and ability to safely&#xD;
                    exercise as reported by the participant or in their medical record,&#xD;
  &#xD;
                 9. Orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that&#xD;
                    greatly limit the ability to perform moderate intensity resistance exercise&#xD;
                    (e.g., unable to be properly positioned in exercise equipment or to have severely&#xD;
                    restricted range of motion even after modifications have been made),&#xD;
  &#xD;
                10. Persons who, in the judgment of the study clinician, appear to have unstable&#xD;
                    health or are incapable of safely participating in the exercise intervention.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Pariya Wheeler, PhD</last_name>
      <phone>205-996-0330</phone>
      <email>plfazeli@uab.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Pariya Wheeler, PhD</last_name>
        <phone>205-996-1210</phone>
        <email>plfazeli@uab.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Colorado Denver</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kristine Erlandson, MD</last_name>
        <phone>303-724-4941</phone>
        <email>kristine.erlandson@ucdenver.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Allison Webel, PhD</last_name>
        <phone>216-650-9227</phone>
        <email>awebel@uw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 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>Pariya L. Fazeli, PhD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>HIV</keyword>
    <keyword>Cognitive Function</keyword>
    <keyword>Exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT06013579
  org study id: 1R01AG077997-01A1
  secondary id: 1R01AG077997-01A1
  nct id: NCT06013579
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and
        although physical activity is a promising target to mitigate such risk, this population
        engages in low levels of physical activity. Few studies have tested cognitive effects of
        exercise interventions or examined mechanisms of adherence to long-term exercise among
        diverse samples of midlife and older people with HIV. The current study will leverage an
        existing R01 to address these gaps and provide implications for development of personalized
        approaches for the treatment and prevention of cognitive impairment and dementia in older
        people with HIV.
  The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's
        disease and related dementias (ADRD) than seronegative counterparts. Although physical
        activity (PA) is a promising protective factor to mitigate ADRD risk, few well-powered PA
        intervention studies have rigorously tested cognitive outcomes among older PWH, a population
        with rates of moderate to vigorous PA well below recommended guidelines. Further, given that
        adherence to habitual PA diminishes after supervised interventions, identifying mechanisms of
        adherence (MoA) to habitual PA among older PWH is germane to develop effective and durable
        interventions to protect cognitive health. The proposed R01 will leverage the High-Intensity
        Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), a
        two-site RCT (University of Washington [UW], University of Colorado Denver [UCD]) of 100
        older PWH examining: 1) if 4 months of supervised high-intensity interval training (HIIT)
        mitigates physical function impairments and fatigue to a greater extent than continuous
        moderate exercise (CME); 2) the effects of a 3 month text-messaging intervention on PA
        adherence. In contrast to CME, where aerobic exercise is performed continuously for a
        specified duration, HIIT, which uses repeated alternating bouts of highintensity and lower
        intensity aerobic exercise, has shown superior efficacy in improving physiological and
        cognitive outcomes, and is associated with superior enjoyment which may increase adherence to
        PA regimens. The proposed R01 (HEALTH-COG) will leverage the two HEALTH sites, add a new
        racially diverse UAB site, and add new measures (psychological MoA measures, cognitive
        function assessments, biomarkers) and a few 12 month follow-up to the parent study. We
        estimate that of our planned sample of N=100, n=50 will be enrolled at UAB and n=50 total at
        UW and UCD. Our primary aim is to compare the effects of a 4 month supervised HIIT or CME
        intervention on (1°) cognitive functioning and (2°) subjective cognitive symptoms. Our
        exploratory aim is to evaluate putative biomarkers underlying the effect of PA on cognition
        (blood markers: e.g., BDNF, VEGF, IL-6 and neuroimaging markers: cerebral blood flow, resting
        state functional connectivity, and brain volume). Our secondary aim is to determine MoA to
        long-term PA maintenance at 12 months. This aim will examine distal predictors of long-term
        PA, including sociodemographic, clinical, and intervention factors (i.e., changes in parent
        R01 physical outcomes [cardiorespiratory fitness], condition [HIIT vs CME], [coaching vs
        control]), as well as proximal psychological MoA assessed in real-time, using EMA (e.g.,
        self-efficacy, perceived benefits, motivation, social support). Testing efficacy and
        mechanisms of exercise interventions on cognitive outcomes and understanding psychological
        MoA of habitual PA following supervised interventions will aid in the development and
        implementation of personalized medicine approaches for the treatment and prevention of
        cognitive impairment and ADRD in older PWH.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  measure: Cognition
  time frame: Baseline visit
  description: Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
  measure: Cognition
  time frame: 4 month follow-up visit
  description: Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
  measure: Cognition
  time frame: 7 month follow-up visit
  description: Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
  measure: Cognition
  time frame: 12 month follow-up visit
  description: Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
  measure: Psychological Mechanisms of Adherence
  time frame: 12 month follow-up visit
  description: Measures of mechanisms of adherence include self-efficacy, motivation, self-regulation strategies, outcome expectations, affective states, and social cohesion and support via in-person surveys and interviews.
  arm group label: Continuous Moderate Exercise (CME)
  arm group type: Active Comparator
  description: Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
  arm group label: High-Intensity Interval Training (HIIT)
  arm group type: Active Comparator
  description: Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
  intervention type: Behavioral
  intervention name: Phase 1 Gym Exercise HIIT
  description: Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
  arm group label: High-Intensity Interval Training (HIIT)
  intervention type: Behavioral
  intervention name: Phase 1 Gym Exercise CME
  description: Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
  arm group label: Continuous Moderate Exercise (CME)
  intervention type: Behavioral
  intervention name: Phase 2 Home Exercise Coaching Text Messages
  description: The coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.
  arm group label: Continuous Moderate Exercise (CME)
  arm group label: High-Intensity Interval Training (HIIT)
  intervention type: Behavioral
  intervention name: Phase 2 Home Exercise Control Text Messages
  description: The control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
  arm group label: Continuous Moderate Exercise (CME)
  arm group label: High-Intensity Interval Training (HIIT)
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pariya Wheeler, PhD
  phone: 205-996-0330
  email: plfazeli@uab.edu
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Pariya L. Fazeli, PhD
  investigator title: Associate Professor
  mesh term: HIV Infections
  mesh term: Cognitive Dysfunction