<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/NCT03281668</url>
  </required_header>
  <id_info>
    <org_study_id>16-2996</org_study_id>
    <secondary_id>1R21HD088852-01A1</secondary_id>
    <nct_id>NCT03281668</nct_id>
  </id_info>
  <brief_title>Feasibility of High Intensity Interval Training in Knee Osteoarthritis</brief_title>
  <official_title>Feasibility of High Intensity Interval Training in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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 focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based&#xD;
      high intensity interval training program (HIIT) to improve physical function in patients with&#xD;
      knee osteoarthritis (OA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will be assigned to the single-arm of the study in which all participants&#xD;
      will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the&#xD;
      feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms&#xD;
      ranging from mild to severe. The investigators will determine adherence to and tolerability&#xD;
      of HIIT, acceptability, and recruitment and retention rates during the 12 week program.&#xD;
      Additional outcomes will include physical function, knee OA symptomatic burden (pain), static&#xD;
      standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and&#xD;
      body composition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Group assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Potential Participants Screened for the Study Who Are Enrolled</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of participants screened and enrolled divided by the total number of participants screened</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Enrolled Participants Retained at the End of the Study</measure>
    <time_frame>Study completion (12 weeks)</time_frame>
    <description>Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Number of Training Sessions Completed Per Week</measure>
    <time_frame>Weekly measures for 12 consecutive weeks</time_frame>
    <description>Up to 2 training sessions were possible each week over the 12 week intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Training Sessions Completed</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Training Weeks Completed</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total number of training weeks (up to 12 weeks possible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks</measure>
    <time_frame>Baseline,12 weeks</time_frame>
    <description>The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC Pain Subscale From Baseline to 12 Weeks</measure>
    <time_frame>Baseline,12 weeks</time_frame>
    <description>The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC Function Subscale From Baseline to 12 Weeks</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 20m Fast Paced Walk Test</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Chair Stand Repetitions Completed</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Number of chair stand repetitions completed in 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stair Climb Test</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Time in seconds to ascend and descend a flight of stairs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up and Go</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Feet Together Stand</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Feet together stand for up to 10 seconds without assistive device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Semi-tandem Stand</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tandem Stand</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>One foot in front of the other, heel touching toe, for up to 10 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in One Leg Stand</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>One leg stand for up to 30 seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiorespiratory Fitness</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Whole Body Fat Mass</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lean Body Mass</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>lean body mass in kilograms, measured with DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visceral Fat</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>visceral fat in kilograms, measured with DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Strength</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval training (HIIT)</intervention_name>
    <description>Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between the ages of 40 and 75 years old&#xD;
&#xD;
          -  body mass index of 18.5-50 kg/m²&#xD;
&#xD;
          -  exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from&#xD;
             University of North Carolina electronic medical records, and current knee symptoms in&#xD;
             at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and&#xD;
             McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals diagnosed with a cardiovascular condition restricting exercise&#xD;
&#xD;
          -  individuals currently meeting Department of Health and Human Services Guidelines for&#xD;
             physical activity (≥ 150 minutes per week&#xD;
&#xD;
          -  individuals currently doing HIIT&#xD;
&#xD;
          -  individuals currently participating in physical therapy for knee OA&#xD;
&#xD;
          -  individuals currently participating in another OA intervention study&#xD;
&#xD;
          -  received a corticosteroid or hyaluronic acid intra-articular injection in the knee&#xD;
             during the previous 3 weeks or scheduled for during the intervention&#xD;
&#xD;
          -  diagnosis of gout in the knee&#xD;
&#xD;
          -  diagnosis of rheumatoid arthritis&#xD;
&#xD;
          -  diagnosis of fibromyalgia&#xD;
&#xD;
          -  other systemic rheumatic disease&#xD;
&#xD;
          -  severe dementia or other memory loss&#xD;
&#xD;
          -  active diagnosis of psychosis or uncontrolled substance abuse disorder&#xD;
&#xD;
          -  hospitalization for a stroke, heart attack, or heart failure, or had surgery for&#xD;
             blocked arteries in the past 3 months&#xD;
&#xD;
          -  total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior&#xD;
             cruciate ligament (ACL) tear in the past 6 months&#xD;
&#xD;
          -  on a waiting list for total joint replacement&#xD;
&#xD;
          -  severely impaired hearing or speech&#xD;
&#xD;
          -  pregnant or planning to become pregnant while enrolled in the study&#xD;
&#xD;
          -  inability to speak English&#xD;
&#xD;
          -  serious or terminal illness as indicated by referral to hospice or palliative care&#xD;
&#xD;
          -  nursing home residence&#xD;
&#xD;
          -  inability to ride a stationary bike&#xD;
&#xD;
          -  any other health problems that would prohibit safe participation in the study&#xD;
&#xD;
          -  EKG results EKG suggesting the individual would not be able to safely participate in&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne Golightly, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>November 4, 2019</results_first_submitted>
  <results_first_submitted_qc>November 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 22, 2019</results_first_posted>
  <last_update_submitted>November 4, 2019</last_update_submitted>
  <last_update_submitted_qc>November 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03281668/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>scheduling conflict, family circumstance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="44" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Potential Participants Screened for the Study Who Are Enrolled</title>
        <description>Number of participants screened and enrolled divided by the total number of participants screened</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Potential Participants Screened for the Study Who Are Enrolled</title>
          <description>Number of participants screened and enrolled divided by the total number of participants screened</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Enrolled Participants Retained at the End of the Study</title>
        <description>Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments</description>
        <time_frame>Study completion (12 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Enrolled Participants Retained at the End of the Study</title>
          <description>Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Training Sessions Completed Per Week</title>
        <description>Up to 2 training sessions were possible each week over the 12 week intervention</description>
        <time_frame>Weekly measures for 12 consecutive weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Training Sessions Completed Per Week</title>
          <description>Up to 2 training sessions were possible each week over the 12 week intervention</description>
          <units>training sessions per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Training Sessions Completed</title>
        <description>Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Training Sessions Completed</title>
          <description>Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)</description>
          <units>training sessions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Training Weeks Completed</title>
        <description>Total number of training weeks (up to 12 weeks possible)</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Training Weeks Completed</title>
          <description>Total number of training weeks (up to 12 weeks possible)</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks</title>
        <description>The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.</description>
        <time_frame>Baseline,12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks</title>
          <description>The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.</description>
          <units>percentage change in score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.2" lower_limit="-13.6" upper_limit="-4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in WOMAC Pain Subscale From Baseline to 12 Weeks</title>
        <description>The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.</description>
        <time_frame>Baseline,12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in WOMAC Pain Subscale From Baseline to 12 Weeks</title>
          <description>The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.</description>
          <units>percentage change in score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" lower_limit="-2.8" upper_limit="-0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in WOMAC Function Subscale From Baseline to 12 Weeks</title>
        <description>The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in WOMAC Function Subscale From Baseline to 12 Weeks</title>
          <description>The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.</description>
          <units>percentage change in score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" lower_limit="-9.6" upper_limit="-3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 20m Fast Paced Walk Test</title>
        <description>Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <population>Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 20m Fast Paced Walk Test</title>
          <description>Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.</description>
          <population>Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.13" lower_limit="-1.61" upper_limit="-0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Chair Stand Repetitions Completed</title>
        <description>Number of chair stand repetitions completed in 30 seconds</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Chair Stand Repetitions Completed</title>
          <description>Number of chair stand repetitions completed in 30 seconds</description>
          <units>number of chair stands</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.8" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Stair Climb Test</title>
        <description>Time in seconds to ascend and descend a flight of stairs</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Stair Climb Test</title>
          <description>Time in seconds to ascend and descend a flight of stairs</description>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" lower_limit="-2.13" upper_limit="-0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Timed Up and Go</title>
        <description>Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Timed Up and Go</title>
          <description>Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down</description>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" lower_limit="-0.95" upper_limit="-0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Feet Together Stand</title>
        <description>Feet together stand for up to 10 seconds without assistive device</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <population>All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Feet Together Stand</title>
          <description>Feet together stand for up to 10 seconds without assistive device</description>
          <population>All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).</population>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Semi-tandem Stand</title>
        <description>Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Semi-tandem Stand</title>
          <description>Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds</description>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" lower_limit="-0.18" upper_limit="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tandem Stand</title>
        <description>One foot in front of the other, heel touching toe, for up to 10 seconds</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tandem Stand</title>
          <description>One foot in front of the other, heel touching toe, for up to 10 seconds</description>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" lower_limit="-0.33" upper_limit="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in One Leg Stand</title>
        <description>One leg stand for up to 30 seconds</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in One Leg Stand</title>
          <description>One leg stand for up to 30 seconds</description>
          <units>change in seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.41" lower_limit="0.26" upper_limit="6.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cardiorespiratory Fitness</title>
        <description>Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cardiorespiratory Fitness</title>
          <description>Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.</description>
          <units>change in liters/minute</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.03" upper_limit="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Whole Body Fat Mass</title>
        <description>fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Whole Body Fat Mass</title>
          <description>fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)</description>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" lower_limit="-1.10" upper_limit="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lean Body Mass</title>
        <description>lean body mass in kilograms, measured with DXA</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lean Body Mass</title>
          <description>lean body mass in kilograms, measured with DXA</description>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" lower_limit="-0.56" upper_limit="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Visceral Fat</title>
        <description>visceral fat in kilograms, measured with DXA</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visceral Fat</title>
          <description>visceral fat in kilograms, measured with DXA</description>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" lower_limit="-0.40" upper_limit="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Strength</title>
        <description>Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Strength</title>
          <description>Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors</description>
          <units>change in maximum kilograms</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Right knee flexors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" lower_limit="-0.74" upper_limit="7.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left knee flexors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.84" lower_limit="-6.36" upper_limit="4.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right knee extensors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.99" lower_limit="1.80" upper_limit="18.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left knee extensors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.86" lower_limit="0.40" upper_limit="19.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from Baseline through the 12 week follow-up visit (an overall total of 12 weeks).</time_frame>
      <desc>Lab team members who became aware of any adverse event or unanticipated problems related to the study were to notify the PIs immediately. All adverse events and study-related safety events were collected by the study team. Aggregated unanticipated problems and adverse events were reviewed on a monthly basis, or more often if urgent matters arose.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.&#xD;
High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a single arm study so it is not known how HIIT compares to other exercise approaches or interventions for the management of knee OA.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Yvonne Golightly, PhD</name_or_title>
      <organization>University of North Carolina at Chapel Hill/Thurston Arthritis Research Center</organization>
      <phone>919-966-0566</phone>
      <email>golight@email.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03281668
org study id: 16-2996
secondary id: 1R21HD088852-01A1
nct id: NCT03281668
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based
      high intensity interval training program (HIIT) to improve physical function in patients with
      knee osteoarthritis (OA).
All participants will be assigned to the single-arm of the study in which all participants
      will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the
      feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms
      ranging from mild to severe. The investigators will determine adherence to and tolerability
      of HIIT, acceptability, and recruitment and retention rates during the 12 week program.
      Additional outcomes will include physical function, knee OA symptomatic burden (pain), static
      standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and
      body composition.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of Potential Participants Screened for the Study Who Are Enrolled
time frame: Baseline
description: Number of participants screened and enrolled divided by the total number of participants screened
measure: Percentage of Enrolled Participants Retained at the End of the Study
time frame: Study completion (12 weeks)
description: Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments
measure: Average Number of Training Sessions Completed Per Week
time frame: Weekly measures for 12 consecutive weeks
description: Up to 2 training sessions were possible each week over the 12 week intervention
measure: Total Number of Training Sessions Completed
time frame: 12 weeks
description: Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
measure: Total Number of Training Weeks Completed
time frame: 12 weeks
description: Total number of training weeks (up to 12 weeks possible)
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks
time frame: Baseline,12 weeks
description: The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.
measure: Change in WOMAC Pain Subscale From Baseline to 12 Weeks
time frame: Baseline,12 weeks
description: The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.
measure: Change in WOMAC Function Subscale From Baseline to 12 Weeks
time frame: Baseline, 12 weeks
description: The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.
measure: Change in 20m Fast Paced Walk Test
time frame: Baseline, 12 weeks
description: Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.
measure: Change in Number of Chair Stand Repetitions Completed
time frame: Baseline, 12 weeks
description: Number of chair stand repetitions completed in 30 seconds
measure: Change in Stair Climb Test
time frame: Baseline, 12 weeks
description: Time in seconds to ascend and descend a flight of stairs
measure: Change in Timed Up and Go
time frame: Baseline, 12 weeks
description: Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down
measure: Change in Feet Together Stand
time frame: Baseline, 12 weeks
description: Feet together stand for up to 10 seconds without assistive device
measure: Change in Semi-tandem Stand
time frame: Baseline, 12 weeks
description: Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds
measure: Change in Tandem Stand
time frame: Baseline, 12 weeks
description: One foot in front of the other, heel touching toe, for up to 10 seconds
measure: Change in One Leg Stand
time frame: Baseline, 12 weeks
description: One leg stand for up to 30 seconds
measure: Change in Cardiorespiratory Fitness
time frame: Baseline, 12 weeks
description: Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
measure: Change in Whole Body Fat Mass
time frame: Baseline, 12 weeks
description: fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
measure: Change in Lean Body Mass
time frame: Baseline, 12 weeks
description: lean body mass in kilograms, measured with DXA
measure: Change in Visceral Fat
time frame: Baseline, 12 weeks
description: visceral fat in kilograms, measured with DXA
measure: Change in Knee Strength
time frame: Baseline, 12 weeks
description: Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors
arm group label: Intervention
arm group type: Experimental
description: Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.
intervention type: Behavioral
intervention name: High intensity interval training (HIIT)
description: Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yvonne Golightly, PT, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a single arm study so it is not known how HIIT compares to other exercise approaches or interventions for the management of knee OA.
point of contact: 