<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/NCT03039452</url>
  </required_header>
  <id_info>
    <org_study_id>16-0829</org_study_id>
    <secondary_id>1P2CHD086851-01</secondary_id>
    <nct_id>NCT03039452</nct_id>
  </id_info>
  <brief_title>High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics</brief_title>
  <official_title>Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: The purpose of this study will be to examine the feasibility and acceptability of a&#xD;
      6-week high intensity interval training (HIIT) program in patients with knee OA symptoms&#xD;
      ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body&#xD;
      metabolism induced by 6-weeks of HIIT.&#xD;
&#xD;
      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA&#xD;
&#xD;
      Procedures (methods): All participants will be assigned to the single-arm of the study in&#xD;
      which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will&#xD;
      be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,&#xD;
      feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes&#xD;
      will include whole body metabolism markers, inflammation, and a set of physical function&#xD;
      including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness,&#xD;
      isometric knee extensor and flexor strength (factors associated with physical function and&#xD;
      symptomatic knee OA progression), and body composition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility - proportion of potential participants screened for the study who are enrolled</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance: average number of training session completed per week</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence: total number of training session completed per week</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence: total number of training weeks completed</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body metabolism measured by insulin</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body metabolism measured by amino acids</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body metabolism measured by free fatty acids</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole body metabolism measured by an oral glucose tolerance test</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation measured from interleukin-6 and tumor necrosis factor alpha</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain score from baseline to 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Determined from WOMAC pain subscale (range 0-20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptomatic burden score from baseline to 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Determined from the total WOMAC (range 0-96)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory Fitness from peak oxygen consumption test</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Strength (extensors and flexors) from dynamometry</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition from dual energy x-ray absorptiometry</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>High intensity interval training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>Each training session 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>High intensity interval training</arm_group_label>
    <other_name>Stationary bike</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must exhibit symptomatic knee OA (WOMAC &gt; 31), radiographic evidence of tibiofemoral&#xD;
             OA (2-4 Kellgren-Lawrence scale)&#xD;
&#xD;
          -  Age 40-70 years&#xD;
&#xD;
          -  Body mass index 20-35 kg/m²&#xD;
&#xD;
          -  Cleared by study physician from 12 lead EKG and medical history review&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals diagnosed with a cardiovascular condition restricting exercise Individuals&#xD;
             currently meeting Department of Health and Human Services Guidelines for Physical&#xD;
             Activity (meeting &gt;150 minutes of exercise 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 injection involved in the knee in the&#xD;
             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 6 months&#xD;
&#xD;
          -  Diabetics (medications include exogenous insulin)&#xD;
&#xD;
          -  Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear&#xD;
             in the past 12 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 in the next 8 weeks&#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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abbie Smith-Ryan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Applied Physiology Laboratory</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>October 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>October 27, 2017</last_update_submitted>
  <last_update_submitted_qc>October 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT03039452
org study id: 16-0829
secondary id: 1P2CHD086851-01
nct id: NCT03039452
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Purpose: The purpose of this study will be to examine the feasibility and acceptability of a
      6-week high intensity interval training (HIIT) program in patients with knee OA symptoms
      ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body
      metabolism induced by 6-weeks of HIIT.

      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA

      Procedures (methods): All participants will be assigned to the single-arm of the study in
      which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will
      be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,
      feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes
      will include whole body metabolism markers, inflammation, and a set of physical function
      including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness,
      isometric knee extensor and flexor strength (factors associated with physical function and
      symptomatic knee OA progression), and body composition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility - proportion of potential participants screened for the study who are enrolled
time frame: baseline
measure: Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
time frame: 6 weeks
measure: Compliance: average number of training session completed per week
time frame: 6 weeks
measure: Adherence: total number of training session completed per week
time frame: 6 weeks
measure: Adherence: total number of training weeks completed
time frame: 6 weeks
measure: Whole body metabolism measured by insulin
time frame: 6 weeks
measure: Whole body metabolism measured by amino acids
time frame: 6 weeks
measure: Whole body metabolism measured by free fatty acids
time frame: 6 weeks
measure: Whole body metabolism measured by an oral glucose tolerance test
time frame: 6 weeks
measure: Inflammation measured from interleukin-6 and tumor necrosis factor alpha
time frame: 6 weeks
measure: Change in Pain score from baseline to 6 weeks
time frame: baseline, 6 weeks
description: Determined from WOMAC pain subscale (range 0-20)
measure: Change in symptomatic burden score from baseline to 6 weeks
time frame: baseline, 6 weeks
description: Determined from the total WOMAC (range 0-96)
measure: Cardiorespiratory Fitness from peak oxygen consumption test
time frame: 6 weeks
measure: Knee Strength (extensors and flexors) from dynamometry
time frame: 6 weeks
measure: Body Composition from dual energy x-ray absorptiometry
time frame: 6 weeks
arm group label: High intensity interval training
arm group type: Experimental
intervention type: Behavioral
intervention name: High intensity interval training
description: Each training session 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: High intensity interval training
other name: Stationary bike
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abbie Smith-Ryan, 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