<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/NCT03794050</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001191</org_study_id>
    <nct_id>NCT03794050</nct_id>
  </id_info>
  <brief_title>Comparing Acute Aerobic and Resistance Exercise</brief_title>
  <acronym>CAARE</acronym>
  <official_title>Effects of Age, Fitness Level, and Modality on Physiological Response to Acute Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Houston</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 purpose of this study is to determine the effect of age and fitness level on the&#xD;
      physiological response to an acute bout of resistance or aerobic exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Young and middle-aged to older adults who are physically active or not physically active will&#xD;
      participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and&#xD;
      resistance training exercise. Blood will be collected to assess immune function and&#xD;
      metabolism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to&#xD;
    complete enrollment of all participants in a timely manner. Data analyses and publications will&#xD;
    occur with the participants who did complete the study.&#xD;
  </why_stopped>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Monocyte subset and function</measure>
    <time_frame>Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise</time_frame>
    <description>Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte subset and function</measure>
    <time_frame>Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise</time_frame>
    <description>Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte subset and function</measure>
    <time_frame>compare pre-RT to pre-AT</time_frame>
    <description>Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte subset and function</measure>
    <time_frame>compare immediately post-RT to immediately post-AT</time_frame>
    <description>Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocyte subset and function</measure>
    <time_frame>compare 1hr post-RT to 1hr post-AT</time_frame>
    <description>Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell function</measure>
    <time_frame>Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise</time_frame>
    <description>Flow cytometry to identify NK cells and in vitro activity to assess NK activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell function</measure>
    <time_frame>Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise</time_frame>
    <description>Flow cytometry to identify NK cells and in vitro activity to assess NK activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell function</measure>
    <time_frame>compare pre-RT to pre-AT</time_frame>
    <description>Flow cytometry to identify NK cells and in vitro activity to assess NK activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell function</measure>
    <time_frame>compare immediately post-RT to immediately post-AT</time_frame>
    <description>Flow cytometry to identify NK cells and in vitro activity to assess NK activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NK cell function</measure>
    <time_frame>compare 1hr post-RT to 1hr post-AT</time_frame>
    <description>Flow cytometry to identify NK cells and in vitro activity to assess NK activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating relative and absolute counts of T cell subsets</measure>
    <time_frame>Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise</time_frame>
    <description>Flow cytometry to identify T cell subsets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating relative and absolute counts of T cell subsets</measure>
    <time_frame>Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise</time_frame>
    <description>Flow cytometry to identify T cell subsets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating relative and absolute counts of T cell subsets</measure>
    <time_frame>compare pre-RT to pre-AT</time_frame>
    <description>Flow cytometry to identify T cell subsets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating relative and absolute counts of T cell subsets</measure>
    <time_frame>compare immediately post-RT to immediately post-AT</time_frame>
    <description>Flow cytometry to identify T cell subsets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating relative and absolute counts of T cell subsets</measure>
    <time_frame>compare 1hr post-RT to 1hr post-AT</time_frame>
    <description>Flow cytometry to identify T cell subsets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol</measure>
    <time_frame>Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise</time_frame>
    <description>ELISA to measure circulating cortisol (serum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol</measure>
    <time_frame>Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise</time_frame>
    <description>ELISA to measure circulating cortisol (serum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol</measure>
    <time_frame>compare pre-RT to pre-AT</time_frame>
    <description>ELISA to measure circulating cortisol (serum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol</measure>
    <time_frame>compare immediately post-RT to immediately post-AT</time_frame>
    <description>ELISA to measure circulating cortisol (serum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol</measure>
    <time_frame>compare 1hr post-RT to 1hr post-AT</time_frame>
    <description>ELISA to measure circulating cortisol (serum)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Exercise Physiology</condition>
  <arm_group>
    <arm_group_label>resistance training exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants complete one session of resistance training exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aerobic training exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants complete one session of aerobic training exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training exercise</intervention_name>
    <description>randomized complete crossover for acute resistance training exercise session</description>
    <arm_group_label>resistance training exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic training exercise</intervention_name>
    <description>randomized complete crossover for acute aerobic exercise training exercise session</description>
    <arm_group_label>aerobic training exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &quot;Young&quot; Adults: ages 18-30&#xD;
&#xD;
          -  &quot;Older&quot; Adults: ages 55-75 and if a female postmenopausal&#xD;
&#xD;
          -  Participants classified as &quot;trained&quot; must participate in at least 30 minutes of&#xD;
             moderate to vigorous intensity cardiovascular activity at least 3 days per week and&#xD;
             engage in resistance training for all of the major muscle groups approximately 2 days&#xD;
             / week. They must have upheld this activity for the past 3 months&#xD;
&#xD;
          -  Participants classified as &quot;untrained&quot; must be participating in less than 30 minutes&#xD;
             of moderate to vigorous intensity cardiovascular activity and less than 2 days of&#xD;
             resistance training per week for at least the last 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any contraindications to moderate to vigorous exercise&#xD;
&#xD;
          -  Range of motion restrictions that would prevent them from participating in aerobic or&#xD;
             resistance training with proper form (they must be ambulatory)&#xD;
&#xD;
          -  aking medications (prescription or over the counter) known to influence immune&#xD;
             function, including daily NSAID's, beta blockers, statins, bisphosphonates, or&#xD;
             steroids.&#xD;
&#xD;
          -  Have known cardiovascular, respiratory, metabolic, or renal disease, with the&#xD;
             exception of controlled hypertension (as defined by resting BP below 140/90) and/or&#xD;
             controlled asthma (self-reported).&#xD;
&#xD;
          -  Be pregnant&#xD;
&#xD;
          -  Be unable to complete all visits (i.e. must not be planning to leave the Houston area&#xD;
             long-term before concluding their participation in the study which will span several&#xD;
             weeks)&#xD;
&#xD;
          -  Fall outside of a BMI range of (18.5 - 30)&#xD;
&#xD;
          -  Consume alcohol or recreational drugs for 24h prior to visits&#xD;
&#xD;
          -  Older women cannot be pre-menopausal (must have not had a menses for at least 12&#xD;
             months)&#xD;
&#xD;
          -  Unable to speak or read English&#xD;
&#xD;
          -  Participants must not have scheduling conflicts that would prevent them from reporting&#xD;
             to the laboratory of integrated physiology 4 times over the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Markofski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Melissa M Markofski</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are considering making available IDP to others upon request, but would have to get an IRB change because that is not in our protocol</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/NCT03794050
org study id: STUDY00001191
nct id: NCT03794050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effect of age and fitness level on the
      physiological response to an acute bout of resistance or aerobic exercise.
Young and middle-aged to older adults who are physically active or not physically active will
      participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and
      resistance training exercise. Blood will be collected to assess immune function and
      metabolism.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Monocyte subset and function
time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
description: Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
measure: Monocyte subset and function
time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
description: Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
measure: Monocyte subset and function
time frame: compare pre-RT to pre-AT
description: Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
measure: Monocyte subset and function
time frame: compare immediately post-RT to immediately post-AT
description: Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
measure: Monocyte subset and function
time frame: compare 1hr post-RT to 1hr post-AT
description: Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
measure: NK cell function
time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
description: Flow cytometry to identify NK cells and in vitro activity to assess NK activity
measure: NK cell function
time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
description: Flow cytometry to identify NK cells and in vitro activity to assess NK activity
measure: NK cell function
time frame: compare pre-RT to pre-AT
description: Flow cytometry to identify NK cells and in vitro activity to assess NK activity
measure: NK cell function
time frame: compare immediately post-RT to immediately post-AT
description: Flow cytometry to identify NK cells and in vitro activity to assess NK activity
measure: NK cell function
time frame: compare 1hr post-RT to 1hr post-AT
description: Flow cytometry to identify NK cells and in vitro activity to assess NK activity
measure: Circulating relative and absolute counts of T cell subsets
time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
description: Flow cytometry to identify T cell subsets
measure: Circulating relative and absolute counts of T cell subsets
time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
description: Flow cytometry to identify T cell subsets
measure: Circulating relative and absolute counts of T cell subsets
time frame: compare pre-RT to pre-AT
description: Flow cytometry to identify T cell subsets
measure: Circulating relative and absolute counts of T cell subsets
time frame: compare immediately post-RT to immediately post-AT
description: Flow cytometry to identify T cell subsets
measure: Circulating relative and absolute counts of T cell subsets
time frame: compare 1hr post-RT to 1hr post-AT
description: Flow cytometry to identify T cell subsets
measure: Serum cortisol
time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
description: ELISA to measure circulating cortisol (serum)
measure: Serum cortisol
time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
description: ELISA to measure circulating cortisol (serum)
measure: Serum cortisol
time frame: compare pre-RT to pre-AT
description: ELISA to measure circulating cortisol (serum)
measure: Serum cortisol
time frame: compare immediately post-RT to immediately post-AT
description: ELISA to measure circulating cortisol (serum)
measure: Serum cortisol
time frame: compare 1hr post-RT to 1hr post-AT
description: ELISA to measure circulating cortisol (serum)
arm group label: resistance training exercise
arm group type: Experimental
description: All participants complete one session of resistance training exercise
arm group label: aerobic training exercise
arm group type: Experimental
description: All participants complete one session of aerobic training exercise
intervention type: Other
intervention name: Resistance training exercise
description: randomized complete crossover for acute resistance training exercise session
arm group label: resistance training exercise
intervention type: Other
intervention name: Aerobic training exercise
description: randomized complete crossover for acute aerobic exercise training exercise session
arm group label: aerobic training exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa Markofski, PhD
role: Principal Investigator
affiliation: University of Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Melissa M Markofski
investigator title: Assistant Professor
sharing ipd: Undecided
ipd description: We are considering making available IDP to others upon request, but would have to get an IRB change because that is not in our protocol