<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/NCT04449016</url>
  </required_header>
  <id_info>
    <org_study_id>1200680-2</org_study_id>
    <nct_id>NCT04449016</nct_id>
  </id_info>
  <brief_title>Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training</brief_title>
  <official_title>Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California State University, San Marcos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>California State University, San Marcos</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>
      The purpose of this study was to determine if ethnicity alters training responsiveness to a&#xD;
      low dose of high intensity interval training in inactive women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9&#xD;
      sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of&#xD;
      cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is&#xD;
      well-tolerated in inactive individuals. Continuously during each session, heart rate was&#xD;
      monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity&#xD;
      enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to&#xD;
      training, as well as post.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">March 23, 2020</completion_date>
  <primary_completion_date type="Actual">December 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This study was a longitudinal, repeated measures between subjects design.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline in VO2max at 3 weeks</measure>
    <time_frame>3 weeks</time_frame>
    <description>Each participant performed VO2max testing on an electronically-braked cycle ergometer using a ramp protocol. During exercise, subjects expired through a plastic mouthpiece and low resistance valve into tubing connected to a mixing chamber. Measures of ventilation and expired fractions of oxygen and carbon dioxide were obtained throughout exercise by a metabolic cart. Gas exchange data including VO2, VCO2, and ventilation were time-averaged every 15 seconds. The test was terminated when the subject's pedal cadence was below 50 rev/min.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline in cardiac output max at 3 weeks</measure>
    <time_frame>3 weeks</time_frame>
    <description>During the VO2max assessment, participants wore a thoracic impedance device to measure heart rate and stroke volume, calculating their cardiac output.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Improved VO2max and Cardiac Output in Response to Training</condition>
  <arm_group>
    <arm_group_label>Caucasian</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hispanic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>Repeated, brief, and intense exercise bouts separated by active recovery</description>
    <arm_group_label>Caucasian</arm_group_label>
    <arm_group_label>Hispanic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Between the age of 18-45&#xD;
&#xD;
          -  Healthy and non-obese (BMI &lt; 30 kg/m2)&#xD;
&#xD;
          -  Perform less than 150 minutes per week of exercise in the last 12 months&#xD;
&#xD;
          -  100% Caucasian or 100% Hispanic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injured&#xD;
&#xD;
          -  Obese&#xD;
&#xD;
          -  Active&#xD;
&#xD;
          -  Mixed ethnicity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Astorino, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>California State University, San Marcos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California State University San Marcos</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Raleigh JP, Giles MD, Scribbans TD, Edgett BA, Sawula LJ, Bonafiglia JT, Graham RB, Gurd BJ. The impact of work-matched interval training on V̇O2peak and V̇O2 kinetics: diminishing returns with increasing intensity. Appl Physiol Nutr Metab. 2016 Jul;41(7):706-13. doi: 10.1139/apnm-2015-0614. Epub 2016 Feb 29.</citation>
    <PMID>27337599</PMID>
  </reference>
  <reference>
    <citation>Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.</citation>
    <PMID>19199208</PMID>
  </reference>
  <reference>
    <citation>Astorino TA, Schubert MM, Palumbo E, Stirling D, McMillan DW, Cooper C, Godinez J, Martinez D, Gallant R. Magnitude and time course of changes in maximal oxygen uptake in response to distinct regimens of chronic interval training in sedentary women. Eur J Appl Physiol. 2013 Sep;113(9):2361-9. doi: 10.1007/s00421-013-2672-1. Epub 2013 Jun 11.</citation>
    <PMID>23754097</PMID>
  </reference>
  <reference>
    <citation>Bowdon M, Marcovitz P, Jain SK, Boura J, Liroff KG, Franklin BA. Exercise Training in &quot;At-Risk&quot; Black and White Women: A Comparative Cohort Analyses. Med Sci Sports Exerc. 2018 Jul;50(7):1350-1356. doi: 10.1249/MSS.0000000000001580.</citation>
    <PMID>29462100</PMID>
  </reference>
  <reference>
    <citation>Gill JM, Celis-Morales CA, Ghouri N. Physical activity, ethnicity and cardio-metabolic health: does one size fit all? Atherosclerosis. 2014 Feb;232(2):319-33. doi: 10.1016/j.atherosclerosis.2013.11.039. Epub 2013 Nov 23.</citation>
    <PMID>24468145</PMID>
  </reference>
  <reference>
    <citation>Johnson JL, Slentz CA, Duscha BD, Samsa GP, McCartney JS, Houmard JA, Kraus WE. Gender and racial differences in lipoprotein subclass distributions: the STRRIDE study. Atherosclerosis. 2004 Oct;176(2):371-7. doi: 10.1016/j.atherosclerosis.2004.05.018.</citation>
    <PMID>15380461</PMID>
  </reference>
  <reference>
    <citation>Skinner JS, Jaskolski A, Jaskolska A, Krasnoff J, Gagnon J, Leon AS, Rao DC, Wilmore JH, Bouchard C; HERITAGE Family Study. Age, sex, race, initial fitness, and response to training: the HERITAGE Family Study. J Appl Physiol (1985). 2001 May;90(5):1770-6. doi: 10.1152/jappl.2001.90.5.1770.</citation>
    <PMID>11299267</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California State University, San Marcos</investigator_affiliation>
    <investigator_full_name>Todd A. Astorino Ph.D</investigator_full_name>
    <investigator_title>PhD, FACSM</investigator_title>
  </responsible_party>
  <keyword>HIIT</keyword>
  <keyword>Inactive</keyword>
  <keyword>Women</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04449016
org study id: 1200680-2
nct id: NCT04449016
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to determine if ethnicity alters training responsiveness to a
      low dose of high intensity interval training in inactive women.
Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9
      sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of
      cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is
      well-tolerated in inactive individuals. Continuously during each session, heart rate was
      monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity
      enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to
      training, as well as post.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This study was a longitudinal, repeated measures between subjects design.
primary purpose: Prevention
masking: None (Open Label)
measure: Change in baseline in VO2max at 3 weeks
time frame: 3 weeks
description: Each participant performed VO2max testing on an electronically-braked cycle ergometer using a ramp protocol. During exercise, subjects expired through a plastic mouthpiece and low resistance valve into tubing connected to a mixing chamber. Measures of ventilation and expired fractions of oxygen and carbon dioxide were obtained throughout exercise by a metabolic cart. Gas exchange data including VO2, VCO2, and ventilation were time-averaged every 15 seconds. The test was terminated when the subject's pedal cadence was below 50 rev/min.
measure: Change in baseline in cardiac output max at 3 weeks
time frame: 3 weeks
description: During the VO2max assessment, participants wore a thoracic impedance device to measure heart rate and stroke volume, calculating their cardiac output.
arm group label: Caucasian
arm group type: Experimental
description: Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3.
arm group label: Hispanic
arm group type: Experimental
description: Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3.
intervention type: Other
intervention name: High intensity interval training
description: Repeated, brief, and intense exercise bouts separated by active recovery
arm group label: Caucasian
arm group label: Hispanic
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Todd Astorino, PhD
role: Principal Investigator
affiliation: California State University, San Marcos
facility: 
country: United States
citation: Raleigh JP, Giles MD, Scribbans TD, Edgett BA, Sawula LJ, Bonafiglia JT, Graham RB, Gurd BJ. The impact of work-matched interval training on V̇O2peak and V̇O2 kinetics: diminishing returns with increasing intensity. Appl Physiol Nutr Metab. 2016 Jul;41(7):706-13. doi: 10.1139/apnm-2015-0614. Epub 2016 Feb 29.
PMID: 27337599
citation: Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
PMID: 19199208
citation: Astorino TA, Schubert MM, Palumbo E, Stirling D, McMillan DW, Cooper C, Godinez J, Martinez D, Gallant R. Magnitude and time course of changes in maximal oxygen uptake in response to distinct regimens of chronic interval training in sedentary women. Eur J Appl Physiol. 2013 Sep;113(9):2361-9. doi: 10.1007/s00421-013-2672-1. Epub 2013 Jun 11.
PMID: 23754097
citation: Bowdon M, Marcovitz P, Jain SK, Boura J, Liroff KG, Franklin BA. Exercise Training in "At-Risk" Black and White Women: A Comparative Cohort Analyses. Med Sci Sports Exerc. 2018 Jul;50(7):1350-1356. doi: 10.1249/MSS.0000000000001580.
PMID: 29462100
citation: Gill JM, Celis-Morales CA, Ghouri N. Physical activity, ethnicity and cardio-metabolic health: does one size fit all? Atherosclerosis. 2014 Feb;232(2):319-33. doi: 10.1016/j.atherosclerosis.2013.11.039. Epub 2013 Nov 23.
PMID: 24468145
citation: Johnson JL, Slentz CA, Duscha BD, Samsa GP, McCartney JS, Houmard JA, Kraus WE. Gender and racial differences in lipoprotein subclass distributions: the STRRIDE study. Atherosclerosis. 2004 Oct;176(2):371-7. doi: 10.1016/j.atherosclerosis.2004.05.018.
PMID: 15380461
citation: Skinner JS, Jaskolski A, Jaskolska A, Krasnoff J, Gagnon J, Leon AS, Rao DC, Wilmore JH, Bouchard C; HERITAGE Family Study. Age, sex, race, initial fitness, and response to training: the HERITAGE Family Study. J Appl Physiol (1985). 2001 May;90(5):1770-6. doi: 10.1152/jappl.2001.90.5.1770.
PMID: 11299267
responsible party type: Principal Investigator
investigator affiliation: California State University, San Marcos
investigator full name: Todd A. Astorino Ph.D
investigator title: PhD, FACSM
sharing ipd: Undecided