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/NCT05962164</url>
    </required_header>
    <id_info>
      <org_study_id>H21-01868</org_study_id>
      <nct_id>NCT05962164</nct_id>
    </id_info>
    <brief_title>Passive Heat Therapy for People With COPD</brief_title>
    <acronym>COPD</acronym>
    <official_title>The Acute and Chronic Benefits of Passive Heat Therapy for People With COPD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Lung Association</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University of British Columbia</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>
        People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure&#xD;
        and heart disease due to their sedentary lifestyle and difficulty exercising. The&#xD;
        investigators will test if heating can mimic the health benefits of exercise by monitoring&#xD;
        the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The&#xD;
        patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to&#xD;
        blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        People with COPD are at higher risk of developing cardiovascular disease (CVD). While&#xD;
        exercise training is a potent therapy for CVD, people with COPD have a low tolerance for&#xD;
        exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more&#xD;
        effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood&#xD;
        pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout&#xD;
        of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood&#xD;
        pressure in healthy older adults, suggesting that PHT could have similar hypotensive and&#xD;
        anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have&#xD;
        functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance.&#xD;
        No study to date has looked at the acute and chronic hemodynamic and vascular responses to&#xD;
        PHT in people with COPD, nor whether it can acutely or chronically improve exercise&#xD;
        tolerance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel 2-Arm Randomized Control Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Blinding of the participant to the condition (heat therapy or sham) is not possible. Data that needs to be analyzed (i.e. ultrasound videos for blood flow and FMD) will be coded by a team member that is not involved in data collection or analysis. The outcomes assessor will be blind to the participant, condition and time point of the file. Breaking of the code will only occur when all data analysis is complete.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Mean 24-hour ambulatory blood pressure following chronic passive heat therapy</measure>
      <time_frame>6 weeks</time_frame>
      <description>The change in 24-hour ambulatory systolic, diastolic and mean arterial blood pressure from baseline to post intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.</measure>
      <time_frame>6 weeks</time_frame>
      <description>The change in the percent dilation of the superficial femoral artery (measured using ultrasound) in response to reactive hyperemia (from a 5-min supra-systolic occlusion) from baseline to post intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial stiffness following chronic passive heat therapy</measure>
      <time_frame>6 weeks</time_frame>
      <description>The change in pulse wave velocity (m/s) measured by applanation tonometry from baseline to post intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise tolerance following chronic passive heat therapy</measure>
      <time_frame>6 weeks</time_frame>
      <description>The change in constant load exercise time (seconds) at 75% of peak power from baseline to post intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The acute changes in leg blood flow from a single bout of passive heat therapy</measure>
      <time_frame>During procedure: 60-minutes</time_frame>
      <description>Superficial femoral artery blood flow (mL/min) will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy</measure>
      <time_frame>During procedure: 60-minutes</time_frame>
      <description>Superficial femoral artery shear stress (1/s) patterns will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment</measure>
      <time_frame>~48 hours</time_frame>
      <description>Constant load exercise time to exhaustion (seconds) at 75% of Peak Power will be completed at baseline and 15-min after PHT or Sham Immersion. The change in post-PHT time to exhaustion from the baseline exercise trial will be compared with the change in post-sham time to exhaustion from the baseline exercise trial.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>COPD</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Passive Heat Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with COPD assigned to passive heat therapy will have their lower legs immersed in a circulating hot water (~42°C) footbath for 45 min per session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Immersion</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients with COPD assigned to the sham condition will have their lower legs immersed in a circulating thermoneutral (~36°C) footbath for 45 min per session.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Passive Heat Therapy</intervention_name>
      <description>The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.</description>
      <arm_group_label>Passive Heat Therapy</arm_group_label>
      <other_name>Lower-leg Hot Water Immersion</other_name>
      <other_name>Footbath</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sham Immersion</intervention_name>
      <description>The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.</description>
      <arm_group_label>Sham Immersion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-smoking individuals&#xD;
  &#xD;
            -  &gt;40 years of age&#xD;
  &#xD;
            -  Stable (exacerbation free for &gt;6 weeks), moderate-to-severe COPD (post bronchodilator&#xD;
               FEV1/FVC &lt;lower limit of normal and FEV1 z-score &lt;2.51)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Performing structured exercise training (i.e. pulmonary rehabilitation)&#xD;
  &#xD;
            -  Have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure,&#xD;
               previous stroke or myocardial infarction)&#xD;
  &#xD;
            -  Have uncontrolled hypertension (&gt;160/95 mmHg at rest)&#xD;
  &#xD;
            -  Have hypotension (&lt;110/60 mmHg)&#xD;
  &#xD;
            -  Are taking Beta Blockers&#xD;
  &#xD;
            -  Regularly (&gt;1/week) have hot baths (&gt;30 min) or use a hot tub or sauna.&#xD;
  &#xD;
          Exclusion Criteria for exercise outcomes:&#xD;
  &#xD;
            -  Have resting blood pressure &gt; 150/95 mmHg&#xD;
  &#xD;
            -  On supplemental oxygen for hypoxemia.&#xD;
  &#xD;
            -  Musculoskeletal pain that limits their ability to perform stationary cycling.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neil Eves, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Associate Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Neil Eves, PhD</last_name>
      <phone>(250) 807-9676</phone>
      <email>neil.eves@ubc.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kyla Coates, MSc</last_name>
      <phone>(250) 661-7207</phone>
      <email>kyla.coates@ubc.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of British Columbia</name>
        <address>
          <city>Kelowna</city>
          <state>British Columbia</state>
          <zip>V1V2L2</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Neil Eves</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Passive Heat Therapy</keyword>
    <keyword>Pulmonary Rehabilitation</keyword>
    <keyword>Cardiovascular Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular 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>
  
  
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/NCT05962164
  org study id: H21-01868
  nct id: NCT05962164
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure
        and heart disease due to their sedentary lifestyle and difficulty exercising. The
        investigators will test if heating can mimic the health benefits of exercise by monitoring
        the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The
        patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to
        blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.
  People with COPD are at higher risk of developing cardiovascular disease (CVD). While
        exercise training is a potent therapy for CVD, people with COPD have a low tolerance for
        exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more
        effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood
        pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout
        of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood
        pressure in healthy older adults, suggesting that PHT could have similar hypotensive and
        anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have
        functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance.
        No study to date has looked at the acute and chronic hemodynamic and vascular responses to
        PHT in people with COPD, nor whether it can acutely or chronically improve exercise
        tolerance.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel 2-Arm Randomized Control Trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Blinding of the participant to the condition (heat therapy or sham) is not possible. Data that needs to be analyzed (i.e. ultrasound videos for blood flow and FMD) will be coded by a team member that is not involved in data collection or analysis. The outcomes assessor will be blind to the participant, condition and time point of the file. Breaking of the code will only occur when all data analysis is complete.
  measure: Mean 24-hour ambulatory blood pressure following chronic passive heat therapy
  time frame: 6 weeks
  description: The change in 24-hour ambulatory systolic, diastolic and mean arterial blood pressure from baseline to post intervention.
  measure: Flow mediated dilation of the superficial femoral artery following chronic passive heat therapy.
  time frame: 6 weeks
  description: The change in the percent dilation of the superficial femoral artery (measured using ultrasound) in response to reactive hyperemia (from a 5-min supra-systolic occlusion) from baseline to post intervention.
  measure: Arterial stiffness following chronic passive heat therapy
  time frame: 6 weeks
  description: The change in pulse wave velocity (m/s) measured by applanation tonometry from baseline to post intervention.
  measure: Exercise tolerance following chronic passive heat therapy
  time frame: 6 weeks
  description: The change in constant load exercise time (seconds) at 75% of peak power from baseline to post intervention.
  measure: The acute changes in leg blood flow from a single bout of passive heat therapy
  time frame: During procedure: 60-minutes
  description: Superficial femoral artery blood flow (mL/min) will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.
  measure: The acute changes in superficial femoral artery shear stress from a single bout of passive heat therapy
  time frame: During procedure: 60-minutes
  description: Superficial femoral artery shear stress (1/s) patterns will be measured by duplex ultrasound. Measurements will be taken every 15-min throughout immersion until 15-min following the first session of passive heat therapy or Sham treatment.
  measure: The acute change in exercise tolerance following a single bout of PHT vs. the change with sham treatment
  time frame: ~48 hours
  description: Constant load exercise time to exhaustion (seconds) at 75% of Peak Power will be completed at baseline and 15-min after PHT or Sham Immersion. The change in post-PHT time to exhaustion from the baseline exercise trial will be compared with the change in post-sham time to exhaustion from the baseline exercise trial.
  arm group label: Passive Heat Therapy
  arm group type: Experimental
  description: Patients with COPD assigned to passive heat therapy will have their lower legs immersed in a circulating hot water (~42°C) footbath for 45 min per session.
  arm group label: Sham Immersion
  arm group type: Sham Comparator
  description: Patients with COPD assigned to the sham condition will have their lower legs immersed in a circulating thermoneutral (~36°C) footbath for 45 min per session.
  intervention type: Behavioral
  intervention name: Passive Heat Therapy
  description: The intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
  arm group label: Passive Heat Therapy
  other name: Lower-leg Hot Water Immersion
  other name: Footbath
  intervention type: Behavioral
  intervention name: Sham Immersion
  description: The sham intervention will consist of 6 weeks of repeated (3x/week) 45-min lower-leg immersions.
  arm group label: Sham Immersion
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neil Eves, PhD
  role: Principal Investigator
  affiliation: Associate Professor
  last name: Neil Eves, PhD
  phone: (250) 807-9676
  email: neil.eves@ubc.ca
  last name: Kyla Coates, MSc
  phone: (250) 661-7207
  email: kyla.coates@ubc.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Neil Eves
  investigator title: Professor
  mesh term: Cardiovascular Diseases
  sharing ipd: No