<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/NCT02185872</url>
  </required_header>
  <id_info>
    <org_study_id>#6058</org_study_id>
    <nct_id>NCT02185872</nct_id>
  </id_info>
  <brief_title>CrossFit Exercise to Improve Glucose Control for Overweight and Obese Adults</brief_title>
  <official_title>The Influence of a CrossFit Exercise Program on Glucose Control in Overweight and Obese Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to examine the differences in glucose control, fitness, and&#xD;
      body composition between a standard aerobic and resistance exercise training program and a&#xD;
      shorter-duration, high-intensity CrossFit training program in overweight and obese physically&#xD;
      inactive adults.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Both groups would improve glucose control, with the CrossFit group improving&#xD;
           significantly more than the aerobic and resistance training group.&#xD;
&#xD;
        2. Both groups would improve fitness, with the CrossFit group improving significantly more&#xD;
           than the aerobic and resistance training group.&#xD;
&#xD;
        3. Both groups would demonstrate decreases in body fat percentage and fat mass and&#xD;
           increases in lean body mass, with the CrossFit group improving significantly more than&#xD;
           the aerobic and resistance training group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overweight or obese participants will take part in an 8-week exercise intervention after&#xD;
      clearance from a doctor, that is expected to improve glucose control, fitness (Eurofit and&#xD;
      peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body&#xD;
      mass). After stratification by age and body mass index, participants will be randomized to&#xD;
      either a standard aerobic and resistance training exercise program or a relatively higher&#xD;
      intensity, shorter duration CrossFit exercise program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in glucose control.</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Fasting plasma glucose levels were taken after an overnight fast of at least 8 hours. An oral glucose tolerance test was conducted after ingestion of a 75g oral dextrose solution with finger sticks at 30, 45, and 60 minutes from time 0. The following equation was used to calculate glucose area under the curve which was the metric utilized to ascertain changes in glucose control: [(Time 45 - Time 30) * ½ (OGTT 30 + OGTT 45)] + [(Time 60 - Time 45) * ½ (OGTT 60 + OGTT 45)]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in peak aerobic capacity</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Modified Balke protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in sit and reach</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Eurofit protocol for sit and reach distance using flex tester box</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in standing broad jump</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Eurofit protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in vertical jump</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Eurofit protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pushups</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Eurofit protocol; completed on feet or knees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in situps</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>Eurofit protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 40 meter dash</measure>
    <time_frame>Baseline, Week 10</time_frame>
    <description>A handheld stopwatch was used to record time from the command &quot;Go&quot; until the participant crossed the line at 40 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in stork balance test</measure>
    <time_frame>Baseline, Week 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in body composition</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Dual X-ray absorptiometry scan was used to assess body fat percentage, lean body mass, and fat mass.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time spent completing daily workouts</measure>
    <time_frame>24 exercise sessions over 8 weeks</time_frame>
    <description>Time spent to complete each assigned daily workout was individually recorded for each participant</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Aerobic and Resistance Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants completed 24 exercise sessions based on current guidelines. Aerobic exercise (50 min) was performed on machines every session and resistance training (20 min) was performed on machines two sessions per week. Aerobic intensity was prescribed at 40-50% of heart rate reserve (HRR) Weeks 1-4 and 50-60% HRR Weeks 5-8. Resistance training was supervised by an ACE certified personal trainer. One-repetition maximums (1-RM) were assessed Week 1 (i.e., seated bicep curl, military press, seated lat pulldown, seated leg extension, triceps pulldown, bench press, reverse leg curl, seated leg press). For Weeks 2-3 participants completed, 3 sets of 15 reps at 50% 1-RM; Weeks 4-5, 3 sets of 12 reps at 60% 1-RM; Weeks 6-7, 3 sets of 10 reps at 70% 1-RM; Week 8, 3 sets of 8 reps at 75% 1-RM. Three sets of 15 unweighted crunches were completed each day. One minute of rest was taken between each set and each exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-intensity functional training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed a total of 24 sessions that were pre-programmed and led by a certified instructor (CrossFit Level 2), which lasted up to 60 minutes in duration. The first two class periods were structured as an introduction to common movements used in high-intensity functional training (HIFT; e.g., squats, deadlift, press, jerks, barbell, dumbbell, and medicine ball cleans, pullups, kettlebell swings, among others). No scheduled workouts were given on days 1 and 2. Beginning on day 3 each HIFT class consisted of 10-15 minutes of stretching and warmup, 10-20 minutes of instruction and practicing techniques and movements, and 5-30 minutes for the workout of the day, performed at vigorous intensity, relative to each person's ability and fitness level. All weights and movements were individually prescribed and recorded for each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-Intensity Functional Training</intervention_name>
    <description>Participants were instructed to work as hard as they could while maintaining safe technique and proper form to achieve as many reps or rounds as possible in the prescribed time frame. As HIFT participants became accustomed to specific movements, less time was dedicated to practicing movements and technique.</description>
    <arm_group_label>High-intensity functional training</arm_group_label>
    <other_name>CrossFit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic and Resistance Training</intervention_name>
    <description>The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.</description>
    <arm_group_label>Aerobic and Resistance Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index (BMI) of 25 - &lt; 40, physically inactive (i.e., not participating in&#xD;
             any structured exercise programs for the past 2 months and not exceeding 30 total&#xD;
             minutes of physical activity per week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current smoker, pregnant, taking blood glucose altering medications, heart disease,&#xD;
             type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dL or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katie M Heinrich, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pratik Patel, MS, RD</last_name>
    <role>Study Director</role>
    <affiliation>Kansas State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kansas State University</name>
      <address>
        <city>Manhattan</city>
        <state>Kansas</state>
        <zip>66506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Heinrich KM, Patel PM, O'Neal JL, Heinrich BS. High-intensity compared to moderate-intensity training for exercise initiation, enjoyment, adherence, and intentions: an intervention study. BMC Public Health. 2014 Aug 3;14:789. doi: 10.1186/1471-2458-14-789.</citation>
    <PMID>25086646</PMID>
  </results_reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kansas State University</investigator_affiliation>
    <investigator_full_name>Katie M. Heinrich</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Physical Fitness</keyword>
  <keyword>Body Composition, Beneficial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02185872
org study id: #6058
nct id: NCT02185872
lead sponsor: 
has dmc: No
The purpose of this study was to examine the differences in glucose control, fitness, and
      body composition between a standard aerobic and resistance exercise training program and a
      shorter-duration, high-intensity CrossFit training program in overweight and obese physically
      inactive adults.

      Hypotheses:

        1. Both groups would improve glucose control, with the CrossFit group improving
           significantly more than the aerobic and resistance training group.

        2. Both groups would improve fitness, with the CrossFit group improving significantly more
           than the aerobic and resistance training group.

        3. Both groups would demonstrate decreases in body fat percentage and fat mass and
           increases in lean body mass, with the CrossFit group improving significantly more than
           the aerobic and resistance training group.
Overweight or obese participants will take part in an 8-week exercise intervention after
      clearance from a doctor, that is expected to improve glucose control, fitness (Eurofit and
      peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body
      mass). After stratification by age and body mass index, participants will be randomized to
      either a standard aerobic and resistance training exercise program or a relatively higher
      intensity, shorter duration CrossFit exercise program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in glucose control.
time frame: Baseline, Week 10
description: Fasting plasma glucose levels were taken after an overnight fast of at least 8 hours. An oral glucose tolerance test was conducted after ingestion of a 75g oral dextrose solution with finger sticks at 30, 45, and 60 minutes from time 0. The following equation was used to calculate glucose area under the curve which was the metric utilized to ascertain changes in glucose control: [(Time 45 - Time 30) * ½ (OGTT 30 + OGTT 45)] + [(Time 60 - Time 45) * ½ (OGTT 60 + OGTT 45)]
measure: Change from baseline in peak aerobic capacity
time frame: Baseline, Week 10
description: Modified Balke protocol
measure: Change from baseline in sit and reach
time frame: Baseline, Week 10
description: Eurofit protocol for sit and reach distance using flex tester box
measure: Change from baseline in standing broad jump
time frame: Baseline, Week 10
description: Eurofit protocol
measure: Change from baseline in vertical jump
time frame: Baseline, Week 10
description: Eurofit protocol
measure: Change from baseline in pushups
time frame: Baseline, Week 10
description: Eurofit protocol; completed on feet or knees
measure: Change from baseline in situps
time frame: Baseline, Week 10
description: Eurofit protocol
measure: Change from baseline in 40 meter dash
time frame: Baseline, Week 10
description: A handheld stopwatch was used to record time from the command "Go" until the participant crossed the line at 40 meters
measure: Change from baseline in stork balance test
time frame: Baseline, Week 10
measure: Change from baseline in body composition
time frame: Baseline, Week 12
description: Dual X-ray absorptiometry scan was used to assess body fat percentage, lean body mass, and fat mass.
measure: Time spent completing daily workouts
time frame: 24 exercise sessions over 8 weeks
description: Time spent to complete each assigned daily workout was individually recorded for each participant
arm group label: Aerobic and Resistance Training
arm group type: Active Comparator
description: Participants completed 24 exercise sessions based on current guidelines. Aerobic exercise (50 min) was performed on machines every session and resistance training (20 min) was performed on machines two sessions per week. Aerobic intensity was prescribed at 40-50% of heart rate reserve (HRR) Weeks 1-4 and 50-60% HRR Weeks 5-8. Resistance training was supervised by an ACE certified personal trainer. One-repetition maximums (1-RM) were assessed Week 1 (i.e., seated bicep curl, military press, seated lat pulldown, seated leg extension, triceps pulldown, bench press, reverse leg curl, seated leg press). For Weeks 2-3 participants completed, 3 sets of 15 reps at 50% 1-RM; Weeks 4-5, 3 sets of 12 reps at 60% 1-RM; Weeks 6-7, 3 sets of 10 reps at 70% 1-RM; Week 8, 3 sets of 8 reps at 75% 1-RM. Three sets of 15 unweighted crunches were completed each day. One minute of rest was taken between each set and each exercise.
arm group label: High-intensity functional training
arm group type: Experimental
description: Participants completed a total of 24 sessions that were pre-programmed and led by a certified instructor (CrossFit Level 2), which lasted up to 60 minutes in duration. The first two class periods were structured as an introduction to common movements used in high-intensity functional training (HIFT; e.g., squats, deadlift, press, jerks, barbell, dumbbell, and medicine ball cleans, pullups, kettlebell swings, among others). No scheduled workouts were given on days 1 and 2. Beginning on day 3 each HIFT class consisted of 10-15 minutes of stretching and warmup, 10-20 minutes of instruction and practicing techniques and movements, and 5-30 minutes for the workout of the day, performed at vigorous intensity, relative to each person's ability and fitness level. All weights and movements were individually prescribed and recorded for each participant.
intervention type: Other
intervention name: High-Intensity Functional Training
description: Participants were instructed to work as hard as they could while maintaining safe technique and proper form to achieve as many reps or rounds as possible in the prescribed time frame. As HIFT participants became accustomed to specific movements, less time was dedicated to practicing movements and technique.
arm group label: High-intensity functional training
other name: CrossFit
intervention type: Other
intervention name: Aerobic and Resistance Training
description: The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.
arm group label: Aerobic and Resistance Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katie M Heinrich, PhD
role: Principal Investigator
affiliation: Kansas State University
last name: Pratik Patel, MS, RD
role: Study Director
affiliation: Kansas State University
facility: 
country: United States
citation: Heinrich KM, Patel PM, O'Neal JL, Heinrich BS. High-intensity compared to moderate-intensity training for exercise initiation, enjoyment, adherence, and intentions: an intervention study. BMC Public Health. 2014 Aug 3;14:789. doi: 10.1186/1471-2458-14-789.
PMID: 25086646
responsible party type: Principal Investigator
investigator affiliation: Kansas State University
investigator full name: Katie M. Heinrich
investigator title: Assistant Professor
mesh term: Overweight
mesh term: Hyperglycemia