<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/NCT01705951</url>
  </required_header>
  <id_info>
    <org_study_id>19KT-0028</org_study_id>
    <secondary_id>UL1TR000124</secondary_id>
    <nct_id>NCT01705951</nct_id>
  </id_info>
  <brief_title>Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk</brief_title>
  <acronym>START</acronym>
  <official_title>Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is prompted by the urgent public health need to identify novel strategies to&#xD;
      prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data&#xD;
      that suggests cessation of smoking results in rapid amelioration of endothelial function. The&#xD;
      higher prevalence of CVD and metabolic syndrome in smokers have become major health care&#xD;
      concerns. Therefore, finding optimal intervention strategies to combat these growing&#xD;
      epidemics is imperative. We are investigating the efficacy of resistance training to&#xD;
      ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in&#xD;
      four groups: presence or absence of resistance training with or without cessation treatment +&#xD;
      nicotine replacement.&#xD;
&#xD;
      The investigators hypothesize that resistance training will improve cardiovascular function&#xD;
      in smokers; however, the responses will be better in those who also stop smoking. In&#xD;
      addition, resistance training will decrease smoking, however, the effects of counseling and&#xD;
      nicotine replacement alone or counseling and nicotine replacement in conjunction with&#xD;
      resistance training will be better than resistance training alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are conducting a 12-week randomized-controlled trial of 100 young adult&#xD;
      smokers.&#xD;
&#xD;
      At week 0, participants attend three outpatient visits at baseline. Each participant is&#xD;
      randomized to one of four groups: Resistance Training(RT)/Nicotine Replacement Therapy (NRT),&#xD;
      RT/No NRT, No RT/NRT, and No RT/No NRT. Those receiving RT work with a certified personal&#xD;
      trainer 3 times per week for 12 weeks at 60 minutes each session. Those receiving NRT use the&#xD;
      nicotine patch daily for 12 weeks and call the California Smoker's Helpline for smoking&#xD;
      cessation counseling. Those in the control group do not receive any intervention and maintain&#xD;
      their current lifestyle and habits.&#xD;
&#xD;
      At week 13, participants return for three post-intervention assessments.&#xD;
&#xD;
      At week 26, survey data is collected to assess changes in lifestyle habits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking cessation percentage</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial stiffness (including PWV and AIx)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cigarettes smoked</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Endothelial Progenitor Cells (EPC) count</measure>
    <time_frame>12 weeks</time_frame>
    <description>EPC count is measured using a novel flow cytometry protocol.</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)</measure>
    <time_frame>12 Weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)</measure>
    <time_frame>12 Weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body Composition</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Smoking</condition>
  <condition>Cardiovascular Disease Risk</condition>
  <arm_group>
    <arm_group_label>Group 1: Resistance Training/Nicotine Replacement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Resistance Training only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Nicotine Replacement Therapy only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Control; no RT and no NRT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Training (RT)</intervention_name>
    <description>Resistance Training program 3x/week at 60 minutes per session for 12 weeks.</description>
    <arm_group_label>Group 1: Resistance Training/Nicotine Replacement</arm_group_label>
    <arm_group_label>Group 2: Resistance Training only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nicotine Replacement Therapy (NRT)</intervention_name>
    <description>Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.</description>
    <arm_group_label>Group 1: Resistance Training/Nicotine Replacement</arm_group_label>
    <arm_group_label>Group 3: Nicotine Replacement Therapy only</arm_group_label>
    <other_name>GlaxoSmithKline Nicoderm CQ patch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young Adults (18-35 yrs.)&#xD;
&#xD;
          -  Male and female smokers&#xD;
&#xD;
          -  Smokers (smoked at least one cigarette a day for 15 or more days in the last month and&#xD;
             has smoked 100 cigarettes in life)&#xD;
&#xD;
          -  1-3 years experience consistently exercising/training at ≤2 days/wk of RT and ≤1&#xD;
             day/wk of aerobic exercise&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
          -  UCLA students/staff and Non UCLA student/staff&#xD;
&#xD;
          -  Participant in good health as determined by baseline visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented CAD&#xD;
&#xD;
          -  Has had cardiac surgery&#xD;
&#xD;
          -  Currently in weight loss or exercise program in the 6 months prior to participation.&#xD;
&#xD;
          -  Use of medications that influence CV function or preclude the ability to train&#xD;
&#xD;
          -  Syndromes or prescribed medications that may influence CVD, body composition, or&#xD;
             insulin action (e.g. prednisone, Ritalin, Adderall, GH)&#xD;
&#xD;
          -  Unable to exercise&#xD;
&#xD;
          -  Diagnosed with syndromes or diseases that may influence body composition and CV risk&#xD;
             (e.g. Cushing syndrome).&#xD;
&#xD;
          -  Known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading&#xD;
             that would prevent someone from performing the exercise intervention. If the subject&#xD;
             demonstrates abnormal ECG during their pre-intervention visit (or any follow-up visit)&#xD;
             the subject's ECG will be reviewed (for approval) by a cardiologist to continue in the&#xD;
             study.&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Use of hormonal contraceptives&#xD;
&#xD;
          -  Currently in a smoking cessation program including use of NRT within the month of&#xD;
             participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian K Roberts, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Exercise and Metabolic Disease Laboratory</last_name>
    <email>info@uclaemdr.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Christian Roberts, PhD</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Endothelial Function</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Resistance Training</keyword>
  <keyword>Nicotine Replacement</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Arterial Stiffness</keyword>
  <keyword>Body Composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_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/NCT01705951
org study id: 19KT-0028
secondary id: UL1TR000124
nct id: NCT01705951
lead sponsor: 
collaborator: 
has dmc: No
This project is prompted by the urgent public health need to identify novel strategies to
      prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data
      that suggests cessation of smoking results in rapid amelioration of endothelial function. The
      higher prevalence of CVD and metabolic syndrome in smokers have become major health care
      concerns. Therefore, finding optimal intervention strategies to combat these growing
      epidemics is imperative. We are investigating the efficacy of resistance training to
      ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in
      four groups: presence or absence of resistance training with or without cessation treatment +
      nicotine replacement.

      The investigators hypothesize that resistance training will improve cardiovascular function
      in smokers; however, the responses will be better in those who also stop smoking. In
      addition, resistance training will decrease smoking, however, the effects of counseling and
      nicotine replacement alone or counseling and nicotine replacement in conjunction with
      resistance training will be better than resistance training alone.
The investigators are conducting a 12-week randomized-controlled trial of 100 young adult
      smokers.

      At week 0, participants attend three outpatient visits at baseline. Each participant is
      randomized to one of four groups: Resistance Training(RT)/Nicotine Replacement Therapy (NRT),
      RT/No NRT, No RT/NRT, and No RT/No NRT. Those receiving RT work with a certified personal
      trainer 3 times per week for 12 weeks at 60 minutes each session. Those receiving NRT use the
      nicotine patch daily for 12 weeks and call the California Smoker's Helpline for smoking
      cessation counseling. Those in the control group do not receive any intervention and maintain
      their current lifestyle and habits.

      At week 13, participants return for three post-intervention assessments.

      At week 26, survey data is collected to assess changes in lifestyle habits.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)
time frame: 12 weeks
measure: Smoking cessation percentage
time frame: 12 weeks
measure: Arterial stiffness (including PWV and AIx)
time frame: 12 weeks
measure: Number of cigarettes smoked
time frame: 12 weeks
measure: Endothelial Progenitor Cells (EPC) count
time frame: 12 weeks
description: EPC count is measured using a novel flow cytometry protocol.
measure: Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)
time frame: 12 Weeks
measure: Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)
time frame: 12 Weeks
measure: Body Composition
time frame: 12 Weeks
description: Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan.
measure: Muscle Strength
time frame: 12 Weeks
description: Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test.
arm group label: Group 1: Resistance Training/Nicotine Replacement
arm group type: Experimental
arm group label: Group 2: Resistance Training only
arm group type: Experimental
arm group label: Group 3: Nicotine Replacement Therapy only
arm group type: Experimental
arm group label: Group 4: Control; no RT and no NRT
arm group type: No Intervention
intervention type: Other
intervention name: Resistance Training (RT)
description: Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
arm group label: Group 1: Resistance Training/Nicotine Replacement
arm group label: Group 2: Resistance Training only
intervention type: Biological
intervention name: Nicotine Replacement Therapy (NRT)
description: Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
arm group label: Group 1: Resistance Training/Nicotine Replacement
arm group label: Group 3: Nicotine Replacement Therapy only
other name: GlaxoSmithKline Nicoderm CQ patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christian K Roberts, Ph.D
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Exercise and Metabolic Disease Laboratory
email: info@uclaemdr.com
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Christian Roberts, PhD
investigator title: Research Associate Professor
mesh term: Cardiovascular Diseases
mesh term: Nicotine