<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/NCT02189018</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00059151</org_study_id>
    <nct_id>NCT02189018</nct_id>
  </id_info>
  <brief_title>Activity To Improve Outcomes in Peripheral Arterial Disease</brief_title>
  <acronym>ACTION</acronym>
  <official_title>Activity To Improve Outcomes in Peripheral Arterial Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baltimore VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baltimore VA Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs&#xD;
      and decreased blood flow to the legs. This may cause difficulty or pain with walking or other&#xD;
      activities that use leg muscles. Exercise may help improve blood flow in the legs and improve&#xD;
      the ability to walk. This research project is being implemented in adults with PAD to examine&#xD;
      the effects of exercise or weight loss programs on lower extremity blood flow, health, and&#xD;
      physical function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study seeks to gather data on different exercise interventions in PAD.&#xD;
      Collectively, the proposed studies will gather data on the role of novel exercise&#xD;
      interventions in those with PAD who are receiving conservative treatment as well as those who&#xD;
      have undergone an endovascular intervention for lower extremity arterial disease.&#xD;
&#xD;
      We hypothesize that patients who undergo an exercise intervention will: A) show improved&#xD;
      lower extremity perfusion and B) improve their functional ability, compared to a standard&#xD;
      care control group over 6 months of follow-up. We further hypothesize that these improvements&#xD;
      are mediated through angiogenesis and increased perfusion of the lower limb, as well as&#xD;
      improvements in muscle strength, mass, and function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">July 4, 2023</completion_date>
  <primary_completion_date type="Actual">July 4, 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower extremity perfusion</measure>
    <time_frame>6 months</time_frame>
    <description>Ankle brachial index and ultrasound quantification of muscle perfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>6 months</time_frame>
    <description>Treadmill exercise testing</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Peripheral Arterial Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ad lib activity at home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active exercise on treadmill</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuromuscular electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight loss and active exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weight loss plus active exercise on treadmill</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Exercise</intervention_name>
    <description>Active exercise on a treadmill</description>
    <arm_group_label>Active Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuromuscular electrical stimulation</intervention_name>
    <description>Neuromuscular electrical stimulation</description>
    <arm_group_label>Neuromuscular electrical stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight loss and active exercise</intervention_name>
    <description>Weight loss and active exercise on a treadmill</description>
    <arm_group_label>Weight loss and active exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ad lib activity at home</intervention_name>
    <description>Ad lib activity at home</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-90 years&#xD;
&#xD;
          -  Ankle brachial index &lt; 0.9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer under active treatment, except prostate, skin, and hematologic cancers&#xD;
&#xD;
          -  Planned for open lower extremity bypass surgery&#xD;
&#xD;
          -  Body mass index &gt;45&#xD;
&#xD;
          -  Lower extremity gangrene&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brajesh K Lal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baltimore VAMC, University of Maryland School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baltimore VAMC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baltimore VA Medical Center</investigator_affiliation>
    <investigator_full_name>Brajesh K Lal</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Peripheral arterial disease</keyword>
  <keyword>Endovascular</keyword>
  <keyword>Exercise</keyword>
  <keyword>Perfusion</keyword>
  <keyword>Functional capacity</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>
    <mesh_term>Arterial Occlusive 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/NCT02189018
org study id: HP-00059151
nct id: NCT02189018
lead sponsor: 
has dmc: Yes
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs
      and decreased blood flow to the legs. This may cause difficulty or pain with walking or other
      activities that use leg muscles. Exercise may help improve blood flow in the legs and improve
      the ability to walk. This research project is being implemented in adults with PAD to examine
      the effects of exercise or weight loss programs on lower extremity blood flow, health, and
      physical function.
This pilot study seeks to gather data on different exercise interventions in PAD.
      Collectively, the proposed studies will gather data on the role of novel exercise
      interventions in those with PAD who are receiving conservative treatment as well as those who
      have undergone an endovascular intervention for lower extremity arterial disease.

      We hypothesize that patients who undergo an exercise intervention will: A) show improved
      lower extremity perfusion and B) improve their functional ability, compared to a standard
      care control group over 6 months of follow-up. We further hypothesize that these improvements
      are mediated through angiogenesis and increased perfusion of the lower limb, as well as
      improvements in muscle strength, mass, and function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lower extremity perfusion
time frame: 6 months
description: Ankle brachial index and ultrasound quantification of muscle perfusion
measure: Functional capacity
time frame: 6 months
description: Treadmill exercise testing
arm group label: Control
arm group type: Active Comparator
description: Ad lib activity at home
arm group label: Active Exercise
arm group type: Experimental
description: Active exercise on treadmill
arm group label: Neuromuscular electrical stimulation
arm group type: Experimental
description: Neuromuscular electrical stimulation
arm group label: Weight loss and active exercise
arm group type: Experimental
description: Weight loss plus active exercise on treadmill
intervention type: Other
intervention name: Active Exercise
description: Active exercise on a treadmill
arm group label: Active Exercise
intervention type: Other
intervention name: Neuromuscular electrical stimulation
description: Neuromuscular electrical stimulation
arm group label: Neuromuscular electrical stimulation
intervention type: Other
intervention name: Weight loss and active exercise
description: Weight loss and active exercise on a treadmill
arm group label: Weight loss and active exercise
intervention type: Other
intervention name: Ad lib activity at home
description: Ad lib activity at home
arm group label: Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Brajesh K Lal, MD
role: Principal Investigator
affiliation: Baltimore VAMC, University of Maryland School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baltimore VA Medical Center
investigator full name: Brajesh K Lal
investigator title: Professor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Arterial Occlusive Diseases