<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/NCT03251391</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00140692</org_study_id>
    <nct_id>NCT03251391</nct_id>
  </id_info>
  <brief_title>Cardiac Rehabilitation Program in Peripheral Arterial Disease</brief_title>
  <official_title>To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</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 main purpose of this study is to see if it is safe and feasible to use cardiac&#xD;
      rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful&#xD;
      revascularization. This study will also test if CR improves quality of life and health&#xD;
      outcomes in PAD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2017</start_date>
  <completion_date type="Actual">May 11, 2019</completion_date>
  <primary_completion_date type="Actual">May 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 6 minute walk test</measure>
    <time_frame>Change from Baseline to Up to 6 Months</time_frame>
    <description>Results will be measured in meters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey 36 (SF-36)</measure>
    <time_frame>Change from Baseline to Up to 6 Months</time_frame>
    <description>Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey 36 (SF-36)</measure>
    <time_frame>Change from Baseline to Week 18</time_frame>
    <description>Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Quality of Life Questionnaire-6 (VascuQol6)</measure>
    <time_frame>Change from Baseline to Up to 6 Months</time_frame>
    <description>The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.&#xD;
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Quality of Life Questionnaire-6 (VascuQol6)</measure>
    <time_frame>Change from Baseline to Week 18</time_frame>
    <description>The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.&#xD;
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Claudication Distance (ACD)</measure>
    <time_frame>Change from Baseline to Up to 6 Months</time_frame>
    <description>ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Claudication Distance (FCD)</measure>
    <time_frame>Change from Baseline to Up to 6 Months</time_frame>
    <description>FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Cardiac Rehabilitation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this group will undergo cardiac rehabilitation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac Rehabilitation Program</intervention_name>
    <description>Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.&#xD;
Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.</description>
    <arm_group_label>Cardiac Rehabilitation Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Therapy</intervention_name>
    <description>Participants will be asked to complete tests and questionnaires that would normally be done for their condition.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with PAD post-revascularization (stent, angioplasty, or bypass).&#xD;
&#xD;
          -  Patients must have the ability to ambulate safely without assistance and should not&#xD;
             have plans for undergoing further staged revascularization procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below or above the knee amputation.&#xD;
&#xD;
          -  Underlying cardiopulmonary or other co-morbidity that would be an exclusion under&#xD;
             currently approved standard CR protocols at the University of Kansas Medical Center&#xD;
             (KUMC).&#xD;
&#xD;
          -  Unfavorable short term prognosis and limited life expectancy (&lt;2 years)&#xD;
&#xD;
          -  Awaiting a planned staged revascularization in same or other leg (patients will be&#xD;
             eligible once no further procedures are planned).&#xD;
&#xD;
          -  Prior history of having dropped out of CR without completing.&#xD;
&#xD;
          -  Unwilling to consent for all aspects of CR or study participation.&#xD;
&#xD;
          -  Unable to come for CR (this will exclude patients who live far away or have no means&#xD;
             to travel to the CR facility).&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamal Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>revascularization</keyword>
  <keyword>blocked arteries</keyword>
  <keyword>leg arteries</keyword>
  <keyword>leg pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT03251391
org study id: STUDY00140692
nct id: NCT03251391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to see if it is safe and feasible to use cardiac
      rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful
      revascularization. This study will also test if CR improves quality of life and health
      outcomes in PAD patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in 6 minute walk test
time frame: Change from Baseline to Up to 6 Months
description: Results will be measured in meters.
measure: Short Form Health Survey 36 (SF-36)
time frame: Change from Baseline to Up to 6 Months
description: Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
measure: Short Form Health Survey 36 (SF-36)
time frame: Change from Baseline to Week 18
description: Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
measure: Vascular Quality of Life Questionnaire-6 (VascuQol6)
time frame: Change from Baseline to Up to 6 Months
description: The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
measure: Vascular Quality of Life Questionnaire-6 (VascuQol6)
time frame: Change from Baseline to Week 18
description: The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.
Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
measure: Absolute Claudication Distance (ACD)
time frame: Change from Baseline to Up to 6 Months
description: ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
measure: Functional Claudication Distance (FCD)
time frame: Change from Baseline to Up to 6 Months
description: FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.
arm group label: Cardiac Rehabilitation Group
arm group type: Experimental
description: Participants randomized to this group will undergo cardiac rehabilitation program.
arm group label: Control Group
arm group type: Active Comparator
description: Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
intervention type: Other
intervention name: Cardiac Rehabilitation Program
description: Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.
Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.
arm group label: Cardiac Rehabilitation Group
intervention type: Other
intervention name: Conventional Therapy
description: Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kamal Gupta, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases