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/NCT06027502</url>
    </required_header>
    <id_info>
      <org_study_id>H22-03599</org_study_id>
      <nct_id>NCT06027502</nct_id>
    </id_info>
    <brief_title>Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept</brief_title>
    <official_title>Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        As compared to the general population, those living with a spinal cord injury (SCI) are at a&#xD;
        greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can&#xD;
        help lessen the risk of CV diseases. However, those with higher level SCI have a limited&#xD;
        ability to exercise due to their loss of function. Heat therapy has been shown to promote&#xD;
        significant health benefits in populations with health challenges and has demonstrated a mild&#xD;
        exercise like response. The investigators aim to extend these findings and develop a&#xD;
        practical passive heat therapy program appropriate for safe home use.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The risk of cardiovascular diseases for people with a spinal cord injury (SCI) is&#xD;
        approximately 3x greater than the general population, and Cardiovascular (CV) diseases&#xD;
        account for ~40% of deaths in SCI. Traditional CV risk factors are unable to fully explain&#xD;
        these outcomes. This group also has other secondary complications that are concerning,&#xD;
        including susceptibility to infections and metabolic health issues. Some of the increased&#xD;
        risk in SCI is due to a relatively sedentary lifestyle and insufficient exercise capability.&#xD;
        This is particularly insidious in those living with tetraplegia with poor cardiovascular&#xD;
        responses to exercise or even the inability to exercise due to upper limb paralysis.&#xD;
  &#xD;
        Heat therapy in the form of hot baths and saunas has been utilized for centuries, with common&#xD;
        reports of improved quality of life and overall improved well-being. A 20-year prospective&#xD;
        study on 2,315 middle-aged men (at enrolment) in Finland reported that regular sauna bathing&#xD;
        was associated with reduced risk of sudden cardiac death, coronary heart disease, CV disease,&#xD;
        and all-cause mortality. Further, more frequent sauna bathing sessions were related to a&#xD;
        considerably decreased risk of fatal cardiac and CV events, as well as all-cause mortality&#xD;
        independently from conventional risk factors, activity levels, and diet. The mechanisms which&#xD;
        underlie these improvements remain largely unknown. It has been proposed that CV benefits of&#xD;
        exercise training are partly mediated by repeated increases in core temperature. Exercise and&#xD;
        heat stress elicit many common physiological responses, including increases in core&#xD;
        temperature, heart rate and contractility, redistribution of blood flow, and changes in&#xD;
        conduit vessel endothelial shear stress, all of which are believed to improve CV health.&#xD;
        Additionally, heat exposure and exercise induce the expression of heat shock proteins, which&#xD;
        stabilize a variety of other proteins that reduce vascular inflammation and oxidative stress,&#xD;
        improve NO bioavailability, promote angiogenesis, and improve glucose signaling.&#xD;
  &#xD;
        SCI results in a host of physiological changes that greatly increase CV risk and vascular&#xD;
        dysfunction following injury. Increased arterial stiffness and vascular resistance are common&#xD;
        features in SCI, likely secondary to the loss of sympathetic innervation below the lesion,&#xD;
        increased circulating vasoconstrictors, and subsequent oxidative stress and vascular&#xD;
        inflammation. Heat exposure is a stress to the CV system, like exercise, which may result in&#xD;
        numerous chronic adaptations that improve vascular and metabolic function, resulting in a&#xD;
        profoundly reduced risk of CV disease.&#xD;
  &#xD;
        Passive heat therapy may provide a novel and practical approach to help these individuals.&#xD;
        There have been observed profound improvements in vascular and metabolic function as well as&#xD;
        indications of benefits to the immune system and reductions in inflammation in healthy but&#xD;
        sedentary able-bodied people after long-term passive heat exposure. Similar benefits were&#xD;
        observed in obese women with polycystic ovary syndrome. Recent studies in SCI with lower limb&#xD;
        and full-body (only in low level SCI) immersion have demonstrated the potential of hot water&#xD;
        immersion to be safe, with the potential to stimulate a cardio-protective response. The&#xD;
        proposed pilot study is the first step in developing a unique approach for combating CV&#xD;
        dysfunction in the SCI population.&#xD;
  &#xD;
        Specifically, the goal of this pilot study is to build on the current literature and&#xD;
        demonstrate the safety, tolerance, and effectiveness (providing a mild/moderate exercise&#xD;
        response) of a ~ 45-minute full-body hot water immersion in those with higher level SCI&#xD;
        (T7-C4). Ultimately, the investigators will develop a protocol for translating these and&#xD;
        future findings to the home environment and use of a typical bathtub, thereby demonstrating&#xD;
        that passive heat therapy is a viable approach to improve health in the SCI population.&#xD;
  &#xD;
        Water immersion is the preferred method of heating since it is capable of increasing core&#xD;
        temperature and heart rate at a rate similar to moderate-intensity exercise. It is difficult&#xD;
        to achieve increases in core temperature solely via air convection, including in paraplegic&#xD;
        SCI, as participants rapidly acclimate to the heat with increased sweating, limiting the rise&#xD;
        in core temperature and heart rate. In addition, hot tubs, whirlpools, and baths are&#xD;
        available in the community, and most should provide wheelchair access. In addition, a water&#xD;
        bath in the home is an acceptable alternative to a hot tub to sufficiently raise core body&#xD;
        temperature. Furthermore, water is an excellent conductor of heat, and will provide uniform&#xD;
        heating across the participants' body. This helps eliminate &quot;hot spots&quot; that could result in&#xD;
        a burn, particularly in insensate areas of skin.&#xD;
  &#xD;
        For this study, up to 16 individuals will be recruited from International Collaboration on&#xD;
        Repair Discoveries (ICORD) Physical Activity Research Centre (PARC) Community as well as from&#xD;
        the larger SCI community who live with a T7-C4 injury. In addition, the investigators will be&#xD;
        recruiting up to 6 control participants who are otherwise healthy individuals who do not live&#xD;
        with an SCI. During the single, approximately 45-minute exposure to this passive heating&#xD;
        modality the investigators will be measuring heart rate, blood pressure (mean arterial&#xD;
        pressure), cardiac output, respiration rate and core temperature. This descriptive study will&#xD;
        have each participant attend the lab for a single session.&#xD;
  &#xD;
        After a 20 min of baseline data collection period the participant will be transferred to the&#xD;
        hot tub using a standard Hoyer lift and sling. While in the hot tub they will remain in a&#xD;
        semi-reclined position. Initially the participant will be submersed up to the clavicular&#xD;
        level with one arm out of water until the core temperature reaches 38.5 C (about 20 - 25&#xD;
        minutes), once this temperature has been reached, they will be positioned so that the water&#xD;
        level lays between the waist and mid-sternum. The water level on the participant's body will&#xD;
        be adjusted such that a core temperature of 38.5 C for 20 minutes (typical moderate exercise&#xD;
        duration) is maintained. If the participants core temperature exceeds 39.5 C the session will&#xD;
        be terminated and the participant removed from the hot tub. While in the hot tub the&#xD;
        participant may drink water ad lib with the volume recorded.&#xD;
  &#xD;
        While submersed in the hot tub:&#xD;
  &#xD;
          -  Core temperature, blood pressure, blood flow, and heart rate will be monitored&#xD;
             continuously&#xD;
  &#xD;
          -  Oxygen consumption will be assessed every 5 minutes&#xD;
  &#xD;
          -  Cardiac output will be assessed every 10 minutes&#xD;
  &#xD;
        Once the ~45 min of immersion has been completed the participant will be removed from the hot&#xD;
        tub using the Hoyer lift and placed back on the plinth in a semi-reclined position for 20&#xD;
        minutes of recovery/rest. While in this recovery position core temperature, blood pressure,&#xD;
        blood flow, and heart rate will be monitored continuously.&#xD;
  &#xD;
        After this initial recovery period the investigators will assist the participant as necessary&#xD;
        to help the participant get dressed, weighed, testing equipment removed and will continue&#xD;
        resting comfortably in the participant's everyday wheelchair for 60-90 min.&#xD;
  &#xD;
        The outcome variables to be examined include the following:&#xD;
  &#xD;
          -  Heart rate&#xD;
  &#xD;
          -  Blood pressure (systolic, diastolic, mean arterial pressure, beat to beat)&#xD;
  &#xD;
          -  Core temperature (via CorTemp© &quot;smart pill and Bear Hugger)&#xD;
  &#xD;
          -  Cardiac output&#xD;
  &#xD;
          -  Oxygen consumption&#xD;
  &#xD;
          -  Brachial and cerebral artery blood flow&#xD;
  &#xD;
          -  End tidal gas - respiration rate&#xD;
  &#xD;
          -  Weight loss&#xD;
  &#xD;
        Each of the outcome variables will be examined in both an individual and pooled manner&#xD;
        (average and standard deviation). In addition, any potential group trends (e.g., injury level&#xD;
        [thoracic versus cervical] and severity [ American Spinal Injury Association Impairment Scale&#xD;
        (AIS) score]) in terms of the response to the passive heating stimulus will be examined.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Two groups, those with a cervical level SCI and a control group of non-disabled healthy individuals</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Core temperature</measure>
      <time_frame>Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured by CorTemp smart pill and the Bair Hugger system</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oxygen consumption</measure>
      <time_frame>Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured by open circuit spirometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiac output</measure>
      <time_frame>Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured indirectly by Finopres©</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured indirectly by Finopres©</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured indirectly by Finopres©</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cerebral artery blood flow</measure>
      <time_frame>Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured by arterial doppler ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brachial arterial blood flow</measure>
      <time_frame>Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)</time_frame>
      <description>As measured by arterial doppler ultrasound</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Cardiovascular Diseases</condition>
    <condition>Health Behaviour</condition>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>Passive Heating</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Passive heating will be achieved by approximately 45 min of immersion in a Hot Tub at 40 degrees celsius</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Passive Heating</intervention_name>
      <description>20 minutes of baseline data collection, up to 45 minutes of immersion in the hot tub to achieve a core temperature of 38.5 degrees celsius, followed by up to 90 minutes of recovery.</description>
      <arm_group_label>Passive Heating</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  sedentary to active individuals living with a spinal cord injury and have injury level&#xD;
               between T7 and C4 (of any AIS level)*&#xD;
  &#xD;
            -  at least 2 years post-injury*&#xD;
  &#xD;
            -  be able to do a level transfer with minimal assistance*&#xD;
  &#xD;
            -  engaged in a regular and consistent bowel/bladder management program*&#xD;
  &#xD;
            -  be 19 years of age or older&#xD;
  &#xD;
            -  be able to communicate effectively in English&#xD;
  &#xD;
            -  If present, self-reported well controlled/predictable orthostatic hypertension and/or&#xD;
               autonomic dysreflexia*&#xD;
  &#xD;
            -  be fully vaccinated against COVID-19 (initial 2 doses and 1 booster)&#xD;
  &#xD;
                 -  these criteria do not apply to the non-SCI controls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  smoke/use tobacco products&#xD;
  &#xD;
            -  have any cardiac/respiratory illness or diabetes mellitus&#xD;
  &#xD;
            -  known diverticulitis&#xD;
  &#xD;
            -  hypertensive (Systolic Blood Pressure &gt;140 mmHg and/or Diastolic Blood Pressure &gt;190&#xD;
               mmHg)&#xD;
  &#xD;
            -  scheduled MRI investigation in the 7 days following the data collection session&#xD;
  &#xD;
            -  take prescription medications that affect blood vessels, other than contraceptives&#xD;
  &#xD;
            -  have used an erectile dysfunction related medication (e.g., Viagra or Cialis) in the&#xD;
               past 48 hours&#xD;
  &#xD;
            -  have unhealed fracture, or contracture, that would interfere with a simple chair to&#xD;
               tub transfer and/or donning/doffing clothing&#xD;
  &#xD;
            -  have an unhealed pressure sore of any grade and/or open skin areas&#xD;
  &#xD;
            -  have unstable medical/psychiatric condition or substance abuse disorder that is likely&#xD;
               to affect their ability to complete this study&#xD;
  &#xD;
            -  have underlying health conditions or injuries that would impact their ability to&#xD;
               tolerate a mild exercise response or hot water immersion&#xD;
  &#xD;
            -  have uncontrolled orthostatic hypotension i.e., blood pressure does not return to&#xD;
               normal within 2-3 minutes after standing or transferring*&#xD;
  &#xD;
            -  have underlying health conditions that put them at greater risk for COVID-19 (e.g.,&#xD;
               respiratory illness, compromised immunity, or chronic health condition)&#xD;
  &#xD;
            -  have any COVID-19 related symptoms (e.g., new or worsening cough, shortness of breath,&#xD;
               sore throat, runny nose or nasal congestion, hoarse voice, difficulty swallowing, new&#xD;
               smell or taste disorders, nausea, vomiting, diarrhea, abdominal pain, unexplained&#xD;
               fatigue, chills or headache)&#xD;
  &#xD;
            -  have a fever&#xD;
  &#xD;
            -  have travelled outside Canada or had close contact with anyone who has travelled&#xD;
               outside Canada in the past 14 days&#xD;
  &#xD;
            -  have close contact with anyone with respiratory illness or a confirmed or probable&#xD;
               case of COVID-19&#xD;
  &#xD;
            -  are currently self-isolating&#xD;
  &#xD;
                 -  these criteria do not apply to the non-SCI controls&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James J Laskin, PT,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Occupational Science &amp; Occupational Therapy, UBC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James J Laskin, PT,PhD</last_name>
      <phone>6042003426</phone>
      <email>james.laskin@umontana.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jaimie Borisoff, PhD</last_name>
      <phone>6047874243</phone>
      <email>Jaimie_Borisoff@bcit.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>ICORD Blusson SPinal Cord Centre</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V5Z 1M9</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.</citation>
      <PMID>27270841</PMID>
    </reference>
    <results_reference>
      <citation>Larson EA, Ely BR, Francisco, MA, Brunt VE, Minson CT. Thermoregulatory Response to Acute Passive Heat Exposure in Individuals with Low-level Spinal Cord Injury. FASEB J. 2019;33(1):838.19.</citation>
    </results_reference>
    <results_reference>
      <citation>Gass EM, Gass GC. Thermoregulatory responses to repeated warm water immersion in subjects who are paraplegic. Spinal Cord. 2001 Mar;39(3):149-55. doi: 10.1038/sj.sc.3101117.</citation>
      <PMID>11326325</PMID>
    </results_reference>
    <results_reference>
      <citation>Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplphysiol.00424.2016. Epub 2016 Jul 14.</citation>
      <PMID>27418688</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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>James Laskin</investigator_full_name>
      <investigator_title>Adjunct Profesor</investigator_title>
    </responsible_party>
    <keyword>Spinal cord injury</keyword>
    <keyword>Passive heating</keyword>
    <keyword>Exercise response</keyword>
    <keyword>Cardio protection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06027502
  org study id: H22-03599
  nct id: NCT06027502
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  As compared to the general population, those living with a spinal cord injury (SCI) are at a
        greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can
        help lessen the risk of CV diseases. However, those with higher level SCI have a limited
        ability to exercise due to their loss of function. Heat therapy has been shown to promote
        significant health benefits in populations with health challenges and has demonstrated a mild
        exercise like response. The investigators aim to extend these findings and develop a
        practical passive heat therapy program appropriate for safe home use.
  The risk of cardiovascular diseases for people with a spinal cord injury (SCI) is
        approximately 3x greater than the general population, and Cardiovascular (CV) diseases
        account for ~40% of deaths in SCI. Traditional CV risk factors are unable to fully explain
        these outcomes. This group also has other secondary complications that are concerning,
        including susceptibility to infections and metabolic health issues. Some of the increased
        risk in SCI is due to a relatively sedentary lifestyle and insufficient exercise capability.
        This is particularly insidious in those living with tetraplegia with poor cardiovascular
        responses to exercise or even the inability to exercise due to upper limb paralysis.
  
        Heat therapy in the form of hot baths and saunas has been utilized for centuries, with common
        reports of improved quality of life and overall improved well-being. A 20-year prospective
        study on 2,315 middle-aged men (at enrolment) in Finland reported that regular sauna bathing
        was associated with reduced risk of sudden cardiac death, coronary heart disease, CV disease,
        and all-cause mortality. Further, more frequent sauna bathing sessions were related to a
        considerably decreased risk of fatal cardiac and CV events, as well as all-cause mortality
        independently from conventional risk factors, activity levels, and diet. The mechanisms which
        underlie these improvements remain largely unknown. It has been proposed that CV benefits of
        exercise training are partly mediated by repeated increases in core temperature. Exercise and
        heat stress elicit many common physiological responses, including increases in core
        temperature, heart rate and contractility, redistribution of blood flow, and changes in
        conduit vessel endothelial shear stress, all of which are believed to improve CV health.
        Additionally, heat exposure and exercise induce the expression of heat shock proteins, which
        stabilize a variety of other proteins that reduce vascular inflammation and oxidative stress,
        improve NO bioavailability, promote angiogenesis, and improve glucose signaling.
  
        SCI results in a host of physiological changes that greatly increase CV risk and vascular
        dysfunction following injury. Increased arterial stiffness and vascular resistance are common
        features in SCI, likely secondary to the loss of sympathetic innervation below the lesion,
        increased circulating vasoconstrictors, and subsequent oxidative stress and vascular
        inflammation. Heat exposure is a stress to the CV system, like exercise, which may result in
        numerous chronic adaptations that improve vascular and metabolic function, resulting in a
        profoundly reduced risk of CV disease.
  
        Passive heat therapy may provide a novel and practical approach to help these individuals.
        There have been observed profound improvements in vascular and metabolic function as well as
        indications of benefits to the immune system and reductions in inflammation in healthy but
        sedentary able-bodied people after long-term passive heat exposure. Similar benefits were
        observed in obese women with polycystic ovary syndrome. Recent studies in SCI with lower limb
        and full-body (only in low level SCI) immersion have demonstrated the potential of hot water
        immersion to be safe, with the potential to stimulate a cardio-protective response. The
        proposed pilot study is the first step in developing a unique approach for combating CV
        dysfunction in the SCI population.
  
        Specifically, the goal of this pilot study is to build on the current literature and
        demonstrate the safety, tolerance, and effectiveness (providing a mild/moderate exercise
        response) of a ~ 45-minute full-body hot water immersion in those with higher level SCI
        (T7-C4). Ultimately, the investigators will develop a protocol for translating these and
        future findings to the home environment and use of a typical bathtub, thereby demonstrating
        that passive heat therapy is a viable approach to improve health in the SCI population.
  
        Water immersion is the preferred method of heating since it is capable of increasing core
        temperature and heart rate at a rate similar to moderate-intensity exercise. It is difficult
        to achieve increases in core temperature solely via air convection, including in paraplegic
        SCI, as participants rapidly acclimate to the heat with increased sweating, limiting the rise
        in core temperature and heart rate. In addition, hot tubs, whirlpools, and baths are
        available in the community, and most should provide wheelchair access. In addition, a water
        bath in the home is an acceptable alternative to a hot tub to sufficiently raise core body
        temperature. Furthermore, water is an excellent conductor of heat, and will provide uniform
        heating across the participants' body. This helps eliminate "hot spots" that could result in
        a burn, particularly in insensate areas of skin.
  
        For this study, up to 16 individuals will be recruited from International Collaboration on
        Repair Discoveries (ICORD) Physical Activity Research Centre (PARC) Community as well as from
        the larger SCI community who live with a T7-C4 injury. In addition, the investigators will be
        recruiting up to 6 control participants who are otherwise healthy individuals who do not live
        with an SCI. During the single, approximately 45-minute exposure to this passive heating
        modality the investigators will be measuring heart rate, blood pressure (mean arterial
        pressure), cardiac output, respiration rate and core temperature. This descriptive study will
        have each participant attend the lab for a single session.
  
        After a 20 min of baseline data collection period the participant will be transferred to the
        hot tub using a standard Hoyer lift and sling. While in the hot tub they will remain in a
        semi-reclined position. Initially the participant will be submersed up to the clavicular
        level with one arm out of water until the core temperature reaches 38.5 C (about 20 - 25
        minutes), once this temperature has been reached, they will be positioned so that the water
        level lays between the waist and mid-sternum. The water level on the participant's body will
        be adjusted such that a core temperature of 38.5 C for 20 minutes (typical moderate exercise
        duration) is maintained. If the participants core temperature exceeds 39.5 C the session will
        be terminated and the participant removed from the hot tub. While in the hot tub the
        participant may drink water ad lib with the volume recorded.
  
        While submersed in the hot tub:
  
          -  Core temperature, blood pressure, blood flow, and heart rate will be monitored
             continuously
  
          -  Oxygen consumption will be assessed every 5 minutes
  
          -  Cardiac output will be assessed every 10 minutes
  
        Once the ~45 min of immersion has been completed the participant will be removed from the hot
        tub using the Hoyer lift and placed back on the plinth in a semi-reclined position for 20
        minutes of recovery/rest. While in this recovery position core temperature, blood pressure,
        blood flow, and heart rate will be monitored continuously.
  
        After this initial recovery period the investigators will assist the participant as necessary
        to help the participant get dressed, weighed, testing equipment removed and will continue
        resting comfortably in the participant's everyday wheelchair for 60-90 min.
  
        The outcome variables to be examined include the following:
  
          -  Heart rate
  
          -  Blood pressure (systolic, diastolic, mean arterial pressure, beat to beat)
  
          -  Core temperature (via CorTemp© "smart pill and Bear Hugger)
  
          -  Cardiac output
  
          -  Oxygen consumption
  
          -  Brachial and cerebral artery blood flow
  
          -  End tidal gas - respiration rate
  
          -  Weight loss
  
        Each of the outcome variables will be examined in both an individual and pooled manner
        (average and standard deviation). In addition, any potential group trends (e.g., injury level
        [thoracic versus cervical] and severity [ American Spinal Injury Association Impairment Scale
        (AIS) score]) in terms of the response to the passive heating stimulus will be examined.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Two groups, those with a cervical level SCI and a control group of non-disabled healthy individuals
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Core temperature
  time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured by CorTemp smart pill and the Bair Hugger system
  measure: Oxygen consumption
  time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured by open circuit spirometer
  measure: Cardiac output
  time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured indirectly by Finopres©
  measure: Blood pressure
  time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured indirectly by Finopres©
  measure: Heart rate
  time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured indirectly by Finopres©
  measure: Cerebral artery blood flow
  time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured by arterial doppler ultrasound
  measure: Brachial arterial blood flow
  time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
  description: As measured by arterial doppler ultrasound
  arm group label: Passive Heating
  arm group type: Experimental
  description: Passive heating will be achieved by approximately 45 min of immersion in a Hot Tub at 40 degrees celsius
  intervention type: Behavioral
  intervention name: Passive Heating
  description: 20 minutes of baseline data collection, up to 45 minutes of immersion in the hot tub to achieve a core temperature of 38.5 degrees celsius, followed by up to 90 minutes of recovery.
  arm group label: Passive Heating
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: James J Laskin, PT,PhD
  role: Principal Investigator
  affiliation: Department of Occupational Science & Occupational Therapy, UBC
  last name: James J Laskin, PT,PhD
  phone: 6042003426
  email: james.laskin@umontana.edu
  last name: Jaimie Borisoff, PhD
  phone: 6047874243
  email: Jaimie_Borisoff@bcit.ca
  facility: 
  country: Canada
  citation: Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.
  PMID: 27270841
  citation: Larson EA, Ely BR, Francisco, MA, Brunt VE, Minson CT. Thermoregulatory Response to Acute Passive Heat Exposure in Individuals with Low-level Spinal Cord Injury. FASEB J. 2019;33(1):838.19.
  citation: Gass EM, Gass GC. Thermoregulatory responses to repeated warm water immersion in subjects who are paraplegic. Spinal Cord. 2001 Mar;39(3):149-55. doi: 10.1038/sj.sc.3101117.
  PMID: 11326325
  citation: Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplphysiol.00424.2016. Epub 2016 Jul 14.
  PMID: 27418688
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: James Laskin
  investigator title: Adjunct Profesor
  mesh term: Spinal Cord Injuries
  mesh term: Cardiovascular Diseases
  mesh term: Wounds and Injuries
  sharing ipd: No