xml: <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/NCT06041880</url>
    </required_header>
    <id_info>
      <org_study_id>00022960</org_study_id>
      <nct_id>NCT06041880</nct_id>
    </id_info>
    <brief_title>Passive Calf Stretching Therapy in Peripheral Artery Disease</brief_title>
    <official_title>To Stretch, Not Strain: Impact of Passive Stretching on Calf Muscle and Gait Mechanics in PAD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Penn State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Penn State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the effects of passive calf muscle stretching in&#xD;
        patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer&#xD;
        are:&#xD;
  &#xD;
          1. To determine if daily calf muscle stretching at home improves calf muscle and vascular&#xD;
             health.&#xD;
  &#xD;
          2. To determine if daily calf muscle stretching at home improves walking performance.&#xD;
  &#xD;
        Participants will be asked to place both feet into inflatable ankle splints for 30 minutes a&#xD;
        day, 5 days a week for 4-weeks and 4-weeks of no stretching.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We will ask patients with peripheral artery disease to place both feet into inflatable ankle&#xD;
        splints 30 minutes a day for 4 weeks to passively stretch their calf muscles. Before and&#xD;
        after this 4-week program, we will measure the health and size of their leg blood vessels,&#xD;
        the length and function of their calf muscles and tendons, and how long they can walk without&#xD;
        pain. We will also closely track their joint and foot movements and calf muscle oxygen levels&#xD;
        while they perform walking tests.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>6-minute walk test distance</measure>
      <time_frame>6-12 minutes</time_frame>
      <description>Submaximal exercise test used to assess aerobic capacity and endurance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle to tendon ratio</measure>
      <time_frame>45 minutes</time_frame>
      <description>The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Endothelial function</measure>
      <time_frame>30 minutes</time_frame>
      <description>Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Peripheral Artery Disease</condition>
    <condition>Claudication, Intermittent</condition>
    <arm_group>
      <arm_group_label>4-weeks of passive calf stretching for 30 minutes 5 days a week</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4-weeks of no-stretching</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Passive calf muscle stretching device</intervention_name>
      <description>Modified night splints will be used to passive stretch the calf muscle.</description>
      <arm_group_label>4-weeks of passive calf stretching for 30 minutes 5 days a week</arm_group_label>
      <other_name>Plantar fasciitis night splints</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of PAD&#xD;
  &#xD;
            -  Stable condition (PAD symptoms) for at least 3 months&#xD;
  &#xD;
            -  Age 40-85&#xD;
  &#xD;
            -  Men and women who are not pregnant or nursing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene)&#xD;
  &#xD;
            -  Any condition other than PAD that limits the ability to walk&#xD;
  &#xD;
            -  Major surgery or lower extremity revascularization surgery in the past 6 months&#xD;
  &#xD;
            -  Myocardial infarction within past 6 months or unstable angina&#xD;
  &#xD;
            -  Severe lung disease (on supplemental oxygen or frequently use rescue inhalers)&#xD;
  &#xD;
            -  Participants with non-compressible vessels (ABI &gt; 1.40)&#xD;
  &#xD;
            -  Habitual exercise (30 minutes of continuous activity on 3 or more days per week)&#xD;
  &#xD;
            -  Current tobacco smoker or use of nicotine-containing products&#xD;
  &#xD;
            -  Pregnant or nursing women&#xD;
  &#xD;
            -  History or ankle reconstruction or surgery Recent history (&lt;1 year) of injuries to the&#xD;
               ankle, Achilles tendon, or feet&#xD;
  &#xD;
            -  History of rheumatoid arthritis or other degenerative joint disease&#xD;
  &#xD;
            -  Major medical illness treatment during the prior 12 months&#xD;
  &#xD;
            -  Uncontrolled hypertension&#xD;
  &#xD;
            -  Uncontrolled diabetes&#xD;
  &#xD;
            -  Inability to walk on a treadmill at a slow pace (1.0 mile/hour)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>David N Proctor, Ph.D.</last_name>
      <phone>814-571-5234</phone>
      <email>dnp3@psu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jocelyn M Delgado, B.S.</last_name>
      <phone>408-679-8390</phone>
      <email>jmd956@psu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Penn State University</name>
        <address>
          <city>University Park</city>
          <state>Pennsylvania</state>
          <zip>16802</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Penn State University</investigator_affiliation>
      <investigator_full_name>David N. Proctor, PhD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Endothelial dysfunction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Intermittent Claudication</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041880
  org study id: 00022960
  nct id: NCT06041880
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is to assess the effects of passive calf muscle stretching in
        patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer
        are:
  
          1. To determine if daily calf muscle stretching at home improves calf muscle and vascular
             health.
  
          2. To determine if daily calf muscle stretching at home improves walking performance.
  
        Participants will be asked to place both feet into inflatable ankle splints for 30 minutes a
        day, 5 days a week for 4-weeks and 4-weeks of no stretching.
  We will ask patients with peripheral artery disease to place both feet into inflatable ankle
        splints 30 minutes a day for 4 weeks to passively stretch their calf muscles. Before and
        after this 4-week program, we will measure the health and size of their leg blood vessels,
        the length and function of their calf muscles and tendons, and how long they can walk without
        pain. We will also closely track their joint and foot movements and calf muscle oxygen levels
        while they perform walking tests.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.
  measure: 6-minute walk test distance
  time frame: 6-12 minutes
  description: Submaximal exercise test used to assess aerobic capacity and endurance
  measure: Muscle to tendon ratio
  time frame: 45 minutes
  description: The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound
  measure: Endothelial function
  time frame: 30 minutes
  description: Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.
  arm group label: 4-weeks of passive calf stretching for 30 minutes 5 days a week
  arm group type: Experimental
  description: A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.
  arm group label: 4-weeks of no-stretching
  arm group type: No Intervention
  description: No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.
  intervention type: Device
  intervention name: Passive calf muscle stretching device
  description: Modified night splints will be used to passive stretch the calf muscle.
  arm group label: 4-weeks of passive calf stretching for 30 minutes 5 days a week
  other name: Plantar fasciitis night splints
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: David N Proctor, Ph.D.
  phone: 814-571-5234
  email: dnp3@psu.edu
  last name: Jocelyn M Delgado, B.S.
  phone: 408-679-8390
  email: jmd956@psu.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Penn State University
  investigator full name: David N. Proctor, PhD
  investigator title: Principal Investigator
  mesh term: Peripheral Arterial Disease
  mesh term: Intermittent Claudication
  sharing ipd: No