<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/NCT03288181</url>
  </required_header>
  <id_info>
    <org_study_id>2015-25</org_study_id>
    <nct_id>NCT03288181</nct_id>
  </id_info>
  <brief_title>Effects of Passive Muscle Stretching on Vascular Function and Symptoms of PAD</brief_title>
  <official_title>Effects of Muscle Stretching on Vascular Endothelial Function in Patients With Peripheral Arterial Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tallahassee Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tallahassee Research Institute, Inc.</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>
      Patients with peripheral arterial disease often have walking impairment due to insufficient&#xD;
      oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously&#xD;
      shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus&#xD;
      muscle arterioles and blood flow during exercise. The effect of muscle stretching on&#xD;
      endothelial function and walking distance in patients with peripheral arterial disease is&#xD;
      unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients&#xD;
      with stable symptomatic peripheral artery disease. Patients were randomized to undergo either&#xD;
      4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day,&#xD;
      5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa.&#xD;
      Endothelium-dependent flow-mediated dilation and endothelium- independent&#xD;
      nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were&#xD;
      evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the&#xD;
      other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and&#xD;
      endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6&#xD;
      minute walk test were repeated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized, non-blinded, crossover trial conducted at Tallahassee&#xD;
      Memorial HealthCare, Tallahassee, FL, USA between October 2015 and May 2016. The Tallahassee&#xD;
      Memorial Healthcare Institutional Review Board and the Human Subject Committee at Florida&#xD;
      State University approved the study prior to initiation. Informed written consent was&#xD;
      provided by all patients prior to enrollment.&#xD;
&#xD;
      Study Patients The study sample consisted of patients with stable symptomatic PAD. Inclusion&#xD;
      criteria included reproducible claudication with walking associated with an ankle brachial&#xD;
      index of less than 0.90,15 and/or computed tomographic angiographic evidence of at least a&#xD;
      60% stenosis of the iliac, femoral, or popliteal artery deemed to be the source of&#xD;
      claudication. Individuals with critical limb ischemia or who had severe comorbid conditions&#xD;
      limiting their walking ability were excluded.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Participants were initially randomized to undergo either 4 weeks of passive stretching or 4&#xD;
      weeks of no stretching (control), respectively, followed by cross-over to the other&#xD;
      intervention. Patients were evaluated at baseline, after the first 4 weeks of initial&#xD;
      intervention (stretching or no stretching) and then again after 4wks following the cross-over&#xD;
      intervention (stretching or no stretching). Participants were taught how to apply a simple&#xD;
      dorsiflexion splint and during the 4 wks of daily stretching intervention and applied the&#xD;
      splint daily at home for 30 minutes/day, 5 days/week. Endothelium-dependent flow-mediated&#xD;
      dilation (FMD) and endothelium-independent nitroglycerin-induced dilation (NID) of the&#xD;
      popliteal artery (measured by doppler ultrasound) and a 6 minute walk test were evaluated at&#xD;
      baseline and after each 4 week treatment interval.&#xD;
&#xD;
      Muscle stretching Protocol. To passively stretch each patient's calf muscle, dorsiflexion&#xD;
      splints (Healwell Plantar Fasciitis Night Splint®, FLA Orthopedics, Charlotte, NC, USA) were&#xD;
      applied. Using the splint, ankle joints were kept at 15 degrees of dorsiflexion for 30&#xD;
      min/day, 5 days/wk, for the 4 week interval. The splint has a strap to adjust the angle of&#xD;
      the joint. Participants learned how to wear the splint correctly from a trained physical&#xD;
      therapist who initially fitted and adjusted the splint. Splints were sent home with the&#xD;
      patient and a physical therapist was available for questions by phone. Using the splint, both&#xD;
      the gastrocnemius and soleus muscles were effectively stretched. If participants complained&#xD;
      of pain during muscle stretching, the physical therapist assisted in adjusting the straps,&#xD;
      but efforts were made to maintain the angle of dorsiflexion.&#xD;
&#xD;
      Flow-mediated dilation of the popliteal artery. Vascular functional testing was performed in&#xD;
      a temperature controlled (72 degrees F), quiet and dark laboratory. To exclude the acute&#xD;
      effects of acute exercise or medicine on vascular endothelial function, participants were&#xD;
      asked to refrain from taking sildenafil, tadalafil and vardenafil for 48 hours prior to the&#xD;
      vascular assessment, and not to take carvedilol, cartelol labetalol, verapamil, diltiazem,&#xD;
      nifedipine, nicardipine, isradipine, felodipine and amlodipine for 24 hours prior to the&#xD;
      assessment. Participants were also asked to refrain from any form of exercise and not to eat&#xD;
      or drink for 3 hours prior to the assessment.&#xD;
&#xD;
      Systolic and diastolic blood pressure was measured using an automatic brachial&#xD;
      sphygmomanometer applied to the upper arm after at least 10 min of quiet rest with the&#xD;
      patient seated in the vascular laboratory. Pulse rate was recorded. Participants then assumed&#xD;
      a prone position on a bed and a blood pressure cuff applied to the lower thigh of the most&#xD;
      symptomatic lower extremity. Using vascular ultrasound and Doppler (GE Vivid Q ultrasound&#xD;
      with 12L-RS Linear Vascular Probe, GE, Milwaukee, WI, USA), flow-mediated dilation of the&#xD;
      popliteal artery was measured in the following manner. The measurement was conducted on the&#xD;
      affected leg (leg with greater symptoms or lower ankle-brachial index). First, popliteal&#xD;
      artery diameter and blood flow velocity were recorded after resting for 10 min. A lower thigh&#xD;
      blood pressure cuff was then inflated up to 250 mmHg for 5 min. During the 5 min of arterial&#xD;
      occlusion, participants were asked to remain as still as possible. The blood pressure cuff&#xD;
      was then quickly deflated, and popliteal artery diameter and blood flow remeasured in the&#xD;
      same location for another 10 min. FMD was obtained by referencing the peak popliteal artery&#xD;
      diameter to the baseline measurement.&#xD;
&#xD;
      Endothelium-independent dilation of the popliteal artery. At least 30 min after the&#xD;
      assessment of FMD, nitroglycerin-induced dilation (NID) of the popliteal artery was also&#xD;
      assessed as a measure of endothelium-independent dilation. Baseline popliteal artery diameter&#xD;
      was recorded after resting for 10 min. The recording was done continuously for 10 min after&#xD;
      the administration of 400 µg of sublingual nitroglycerin (NTG, Wilshire, Atlanta, Georgia).&#xD;
      The peak diameter relative to baseline served as the measurement of endothelium-independent&#xD;
      dilatation.&#xD;
&#xD;
      Hemodynamic analyses. Vessel diameter and blood flow velocity were recorded at 30 Hz of&#xD;
      frequency, and converted into DICOM (DICOM, Rosslyn, VA, USA) format to perform further&#xD;
      analysis. Since peripheral arterial diameter and blood flow velocity vary during the cardiac&#xD;
      cycle,16 popliteal artery diameter was measured at the end of the diastolic phase (defined as&#xD;
      the point just before the popliteal arterial Doppler waveform rises). Blood flow velocity was&#xD;
      measured at the peak of the systolic phase. Using two-dimensional B mode images,&#xD;
      end-diastolic popliteal artery diameter and peak velocity were obtained from three&#xD;
      consecutive cardiac cycles, averaged and the same technique used to measure arterial diameter&#xD;
      for FMD and NID.&#xD;
&#xD;
      Six-minute Walk Test (6MWT) The Six-minute walk test (6MWT) was performed after vascular&#xD;
      function testing according to the American Thoracic Society guidelines.Using a straight 30m&#xD;
      corridor, participants were asked to walk back and forth over 6 minutes. Participants were&#xD;
      asked to report any symptoms, including leg pain or cramping, tiredness and/or chest&#xD;
      discomfort. Participants were allowed to rest if they felt it necessary and then asked to&#xD;
      resume walking as soon as able. Symptom-free walking distance was measured as the distance&#xD;
      covered without symptoms. Continuous walking distance was also measured as the distance&#xD;
      covered without stopping. Total 6-minute walking distance was measured as the distance&#xD;
      covered for 6 minutes. Immediately after the 6-minute walk, participants were seated and&#xD;
      again asked to report any chest and lower-extremity symptoms. Chest and lower-extremity&#xD;
      exertional symptoms were assessed using a modified borg scale. The modified borg scale is&#xD;
      scored from zero (no symptoms of exertion) to 10 (maximal sensation of symptoms).&#xD;
      Participants answered the chest and lower-extremity symptoms by indicating a number from zero&#xD;
      to 10. Systolic and diastolic blood pressure and heart rate were then measured at&#xD;
      approximately 1-min after 6-min walk termination.&#xD;
&#xD;
      Sample size calculation. The primary endpoint for which the sample size was derived was&#xD;
      popliteal artery FMD. From published data, we estimated that the FMD of popliteal artery&#xD;
      would improve by approximately 40% with muscle stretching. In a prior pilot study, we&#xD;
      observed a baseline FMD of 3.87% (standard deviation of 0.62%) in 13 patients with stable&#xD;
      PAD. Assuming an alpha of 0.05, and a cross-over design, we predicted that we would need at&#xD;
      least 12 patients per group to have 90% power to detect a 20% increase in FMD. Allowing for&#xD;
      an approximately 20% drop out rate (3 patients), the targeted sample size was adjusted to 15&#xD;
      in this study. However, recruitment was to continue until at least 12 patients were enrolled&#xD;
      and completed the protocol.&#xD;
&#xD;
      Statistical analysis. Baseline clinical characteristics are reported as means and standard&#xD;
      deviations. A histogram of vascular function and walking distance was made to assess their&#xD;
      distribution. If non-normal distribution was suggested by the histogram, a Kolmogorov-smirnov&#xD;
      test was performed to assess the distribution of obtained data. On the basis of the&#xD;
      distribution test, paired t-test (normal distribution) or Wilcoxon signed-rank test&#xD;
      (non-normal distribution) were used to compare between those data obtained after 4 weeks of&#xD;
      stretching and after 4 weeks of no stretching with a 2-sided level of significance of 0.05.&#xD;
      Data were presented as mean ± standard error.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2015</start_date>
  <completion_date type="Actual">June 15, 2016</completion_date>
  <primary_completion_date type="Actual">May 30, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow Mediated Dilatation of the Popliteal Artery</measure>
    <time_frame>Performed 4 weeks after each intervention</time_frame>
    <description>Ultrasound assessment of flow mediated dilatation of the popliteal artery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>Performed 4 weeks after each intervention</time_frame>
    <description>Standard 6 minute walk test to evaluate walking distance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Claudication</condition>
  <arm_group>
    <arm_group_label>Muscle Stretch Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the group who applies the splint to stretch the calf muscles as per the described protocol for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the group who has undergone no splint for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Muscle Stretch</intervention_name>
    <description>The splint will be applied to the affected leg as per the protocol for 30 minutes per day, 5 days per week for 4 weeks.</description>
    <arm_group_label>Muscle Stretch Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with stable symptomatic peripheral arterial disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  critical limb ischemia&#xD;
&#xD;
          -  severe comorbid conditions that limit walking ability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Batchelor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tallahassee Research Institute</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03288181
org study id: 2015-25
nct id: NCT03288181
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with peripheral arterial disease often have walking impairment due to insufficient
      oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously
      shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus
      muscle arterioles and blood flow during exercise. The effect of muscle stretching on
      endothelial function and walking distance in patients with peripheral arterial disease is
      unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients
      with stable symptomatic peripheral artery disease. Patients were randomized to undergo either
      4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day,
      5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa.
      Endothelium-dependent flow-mediated dilation and endothelium- independent
      nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were
      evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the
      other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and
      endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6
      minute walk test were repeated.
This study is a prospective randomized, non-blinded, crossover trial conducted at Tallahassee
      Memorial HealthCare, Tallahassee, FL, USA between October 2015 and May 2016. The Tallahassee
      Memorial Healthcare Institutional Review Board and the Human Subject Committee at Florida
      State University approved the study prior to initiation. Informed written consent was
      provided by all patients prior to enrollment.

      Study Patients The study sample consisted of patients with stable symptomatic PAD. Inclusion
      criteria included reproducible claudication with walking associated with an ankle brachial
      index of less than 0.90,15 and/or computed tomographic angiographic evidence of at least a
      60% stenosis of the iliac, femoral, or popliteal artery deemed to be the source of
      claudication. Individuals with critical limb ischemia or who had severe comorbid conditions
      limiting their walking ability were excluded.

      Study Design:

      Participants were initially randomized to undergo either 4 weeks of passive stretching or 4
      weeks of no stretching (control), respectively, followed by cross-over to the other
      intervention. Patients were evaluated at baseline, after the first 4 weeks of initial
      intervention (stretching or no stretching) and then again after 4wks following the cross-over
      intervention (stretching or no stretching). Participants were taught how to apply a simple
      dorsiflexion splint and during the 4 wks of daily stretching intervention and applied the
      splint daily at home for 30 minutes/day, 5 days/week. Endothelium-dependent flow-mediated
      dilation (FMD) and endothelium-independent nitroglycerin-induced dilation (NID) of the
      popliteal artery (measured by doppler ultrasound) and a 6 minute walk test were evaluated at
      baseline and after each 4 week treatment interval.

      Muscle stretching Protocol. To passively stretch each patient's calf muscle, dorsiflexion
      splints (Healwell Plantar Fasciitis Night Splint®, FLA Orthopedics, Charlotte, NC, USA) were
      applied. Using the splint, ankle joints were kept at 15 degrees of dorsiflexion for 30
      min/day, 5 days/wk, for the 4 week interval. The splint has a strap to adjust the angle of
      the joint. Participants learned how to wear the splint correctly from a trained physical
      therapist who initially fitted and adjusted the splint. Splints were sent home with the
      patient and a physical therapist was available for questions by phone. Using the splint, both
      the gastrocnemius and soleus muscles were effectively stretched. If participants complained
      of pain during muscle stretching, the physical therapist assisted in adjusting the straps,
      but efforts were made to maintain the angle of dorsiflexion.

      Flow-mediated dilation of the popliteal artery. Vascular functional testing was performed in
      a temperature controlled (72 degrees F), quiet and dark laboratory. To exclude the acute
      effects of acute exercise or medicine on vascular endothelial function, participants were
      asked to refrain from taking sildenafil, tadalafil and vardenafil for 48 hours prior to the
      vascular assessment, and not to take carvedilol, cartelol labetalol, verapamil, diltiazem,
      nifedipine, nicardipine, isradipine, felodipine and amlodipine for 24 hours prior to the
      assessment. Participants were also asked to refrain from any form of exercise and not to eat
      or drink for 3 hours prior to the assessment.

      Systolic and diastolic blood pressure was measured using an automatic brachial
      sphygmomanometer applied to the upper arm after at least 10 min of quiet rest with the
      patient seated in the vascular laboratory. Pulse rate was recorded. Participants then assumed
      a prone position on a bed and a blood pressure cuff applied to the lower thigh of the most
      symptomatic lower extremity. Using vascular ultrasound and Doppler (GE Vivid Q ultrasound
      with 12L-RS Linear Vascular Probe, GE, Milwaukee, WI, USA), flow-mediated dilation of the
      popliteal artery was measured in the following manner. The measurement was conducted on the
      affected leg (leg with greater symptoms or lower ankle-brachial index). First, popliteal
      artery diameter and blood flow velocity were recorded after resting for 10 min. A lower thigh
      blood pressure cuff was then inflated up to 250 mmHg for 5 min. During the 5 min of arterial
      occlusion, participants were asked to remain as still as possible. The blood pressure cuff
      was then quickly deflated, and popliteal artery diameter and blood flow remeasured in the
      same location for another 10 min. FMD was obtained by referencing the peak popliteal artery
      diameter to the baseline measurement.

      Endothelium-independent dilation of the popliteal artery. At least 30 min after the
      assessment of FMD, nitroglycerin-induced dilation (NID) of the popliteal artery was also
      assessed as a measure of endothelium-independent dilation. Baseline popliteal artery diameter
      was recorded after resting for 10 min. The recording was done continuously for 10 min after
      the administration of 400 µg of sublingual nitroglycerin (NTG, Wilshire, Atlanta, Georgia).
      The peak diameter relative to baseline served as the measurement of endothelium-independent
      dilatation.

      Hemodynamic analyses. Vessel diameter and blood flow velocity were recorded at 30 Hz of
      frequency, and converted into DICOM (DICOM, Rosslyn, VA, USA) format to perform further
      analysis. Since peripheral arterial diameter and blood flow velocity vary during the cardiac
      cycle,16 popliteal artery diameter was measured at the end of the diastolic phase (defined as
      the point just before the popliteal arterial Doppler waveform rises). Blood flow velocity was
      measured at the peak of the systolic phase. Using two-dimensional B mode images,
      end-diastolic popliteal artery diameter and peak velocity were obtained from three
      consecutive cardiac cycles, averaged and the same technique used to measure arterial diameter
      for FMD and NID.

      Six-minute Walk Test (6MWT) The Six-minute walk test (6MWT) was performed after vascular
      function testing according to the American Thoracic Society guidelines.Using a straight 30m
      corridor, participants were asked to walk back and forth over 6 minutes. Participants were
      asked to report any symptoms, including leg pain or cramping, tiredness and/or chest
      discomfort. Participants were allowed to rest if they felt it necessary and then asked to
      resume walking as soon as able. Symptom-free walking distance was measured as the distance
      covered without symptoms. Continuous walking distance was also measured as the distance
      covered without stopping. Total 6-minute walking distance was measured as the distance
      covered for 6 minutes. Immediately after the 6-minute walk, participants were seated and
      again asked to report any chest and lower-extremity symptoms. Chest and lower-extremity
      exertional symptoms were assessed using a modified borg scale. The modified borg scale is
      scored from zero (no symptoms of exertion) to 10 (maximal sensation of symptoms).
      Participants answered the chest and lower-extremity symptoms by indicating a number from zero
      to 10. Systolic and diastolic blood pressure and heart rate were then measured at
      approximately 1-min after 6-min walk termination.

      Sample size calculation. The primary endpoint for which the sample size was derived was
      popliteal artery FMD. From published data, we estimated that the FMD of popliteal artery
      would improve by approximately 40% with muscle stretching. In a prior pilot study, we
      observed a baseline FMD of 3.87% (standard deviation of 0.62%) in 13 patients with stable
      PAD. Assuming an alpha of 0.05, and a cross-over design, we predicted that we would need at
      least 12 patients per group to have 90% power to detect a 20% increase in FMD. Allowing for
      an approximately 20% drop out rate (3 patients), the targeted sample size was adjusted to 15
      in this study. However, recruitment was to continue until at least 12 patients were enrolled
      and completed the protocol.

      Statistical analysis. Baseline clinical characteristics are reported as means and standard
      deviations. A histogram of vascular function and walking distance was made to assess their
      distribution. If non-normal distribution was suggested by the histogram, a Kolmogorov-smirnov
      test was performed to assess the distribution of obtained data. On the basis of the
      distribution test, paired t-test (normal distribution) or Wilcoxon signed-rank test
      (non-normal distribution) were used to compare between those data obtained after 4 weeks of
      stretching and after 4 weeks of no stretching with a 2-sided level of significance of 0.05.
      Data were presented as mean ± standard error.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Flow Mediated Dilatation of the Popliteal Artery
time frame: Performed 4 weeks after each intervention
description: Ultrasound assessment of flow mediated dilatation of the popliteal artery
measure: Six Minute Walk Test
time frame: Performed 4 weeks after each intervention
description: Standard 6 minute walk test to evaluate walking distance
arm group label: Muscle Stretch Group
arm group type: Experimental
description: This is the group who applies the splint to stretch the calf muscles as per the described protocol for 4 weeks.
arm group label: Control Arm
arm group type: No Intervention
description: This is the group who has undergone no splint for 4 weeks.
intervention type: Device
intervention name: Muscle Stretch
description: The splint will be applied to the affected leg as per the protocol for 30 minutes per day, 5 days per week for 4 weeks.
arm group label: Muscle Stretch Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wayne Batchelor, MD
role: Principal Investigator
affiliation: Tallahassee Research Institute
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No