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/NCT06003712</url>
    </required_header>
    <id_info>
      <org_study_id>20230705</org_study_id>
      <nct_id>NCT06003712</nct_id>
    </id_info>
    <brief_title>Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)</brief_title>
    <official_title>Exploring the Effects of a Mindfulness-Based Intervention on Physiologic and Quality of Life Markers in Individuals With Spinal Cord Injury (SCI): A Pre-post Test Design</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</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>
        The purpose of this study is to determine if practicing mindfulness breathing exercises has&#xD;
        an effect on the overall health of persons with SCI&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Heart rate</measure>
      <time_frame>baseline, 1 month</time_frame>
      <description>heart rate will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. Heart rate will be recorded in beats per minute</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood pressure</measure>
      <time_frame>baseline, 1 month</time_frame>
      <description>Blood pressure (BP) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. BP will be collected as systolic over diastolic in mmHg units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in metabolism as measured by maximum oxygen consumption (VO2)</measure>
      <time_frame>baseline, 1 month</time_frame>
      <description>Metabolism as determined by oxygen consumption (VO2) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VO2 is collected as mL/kg/min</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in metabolism as measured by ventilation (VE)</measure>
      <time_frame>baseline, 1 month</time_frame>
      <description>Metabolism as determined by oxygen consumption (VE) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VE is measured in L/min</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III</measure>
      <time_frame>baseline, 1 month</time_frame>
      <description>A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from &quot;1- very satisfied&quot; to &quot;6-very dissatisfied&quot;. On the important section scoring ranges from &quot;1-very important&quot; to &quot;6- very unimportant&quot;</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Mindfulness Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will participate in a one-month mindfulness breathing-exercise program</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness</intervention_name>
      <description>Participants will engage in a 10-15 minute mindfulness exercise three times weekly for one month. This mindfulness exercise utilizes guided attention on the breath through an instructional video, aiming to cultivate calmness and alleviate stress.</description>
      <arm_group_label>Mindfulness Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult males and females aged 18-70 who are living with spinal cord injury&#xD;
  &#xD;
            -  C5 to the T10 levels&#xD;
  &#xD;
            -  Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS)&#xD;
               A-D&#xD;
  &#xD;
            -  Eligible participants must be able to understand and provide consent, be in good&#xD;
               health operationalized as free from acute treatable illness, pressure injury, and&#xD;
               cardiovascular disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants taking medications that alter chronotropic and pressor responses will be&#xD;
               excluded.&#xD;
  &#xD;
            -  Pregnant women will not be eligible to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Nash, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Jones</last_name>
      <phone>(904) 325-4707</phone>
      <email>cyj323@med.miami.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kayla Samimi</last_name>
      <phone>(310) 855-44332</phone>
      <email>kxs3301@med.miami.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Miami - Miami Project to Cure Paralysis</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Mark S. Nash, Ph.D., FACSM</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</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/NCT06003712
  org study id: 20230705
  nct id: NCT06003712
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine if practicing mindfulness breathing exercises has
        an effect on the overall health of persons with SCI
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Heart rate
  time frame: baseline, 1 month
  description: heart rate will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. Heart rate will be recorded in beats per minute
  measure: Change in blood pressure
  time frame: baseline, 1 month
  description: Blood pressure (BP) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. BP will be collected as systolic over diastolic in mmHg units
  measure: Change in metabolism as measured by maximum oxygen consumption (VO2)
  time frame: baseline, 1 month
  description: Metabolism as determined by oxygen consumption (VO2) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VO2 is collected as mL/kg/min
  measure: Change in metabolism as measured by ventilation (VE)
  time frame: baseline, 1 month
  description: Metabolism as determined by oxygen consumption (VE) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VE is measured in L/min
  measure: Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
  time frame: baseline, 1 month
  description: A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant"
  arm group label: Mindfulness Exercise Group
  arm group type: Experimental
  description: Subjects will participate in a one-month mindfulness breathing-exercise program
  intervention type: Behavioral
  intervention name: Mindfulness
  description: Participants will engage in a 10-15 minute mindfulness exercise three times weekly for one month. This mindfulness exercise utilizes guided attention on the breath through an instructional video, aiming to cultivate calmness and alleviate stress.
  arm group label: Mindfulness Exercise Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Mark Nash, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Caroline Jones
  phone: (904) 325-4707
  email: cyj323@med.miami.edu
  last name: Kayla Samimi
  phone: (310) 855-44332
  email: kxs3301@med.miami.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Mark S. Nash, Ph.D., FACSM
  investigator title: Principal Investigator
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No