<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/NCT01695538</url>
  </required_header>
  <id_info>
    <org_study_id>12946</org_study_id>
    <nct_id>NCT01695538</nct_id>
  </id_info>
  <brief_title>Yoga and Rate and Duration of Inappropriate Sinus Tachycardia (IST) Episodes</brief_title>
  <acronym>YOGA STAR</acronym>
  <official_title>The Effect of Yoga on Arrhythmia Burden and Quality of Life in Patients With Inappropriate Sinus Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dhanunjaya Lakkireddy, MD, FACC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term&#xD;
      &quot;inappropriate&quot; in medicine is commonly defined as a heart rate greater than 100 beats per&#xD;
      minute at rest or with minimal physiological challenge. IST is characterized by an increased&#xD;
      resting heart rate with an exaggerated response to exercise or stress.&#xD;
&#xD;
      Yoga has been used extensively around the world as an alternative medicine approach in&#xD;
      treating numerous chronic and debilitating diseases. Studies have been conducted in various&#xD;
      countries to determine the benefits of Yoga as therapy for these chronic diseases. Several&#xD;
      studies have confirmed that yoga can reduce anxiety and regulate the stress response.&#xD;
&#xD;
      Studies in the past have shown that Yoga relieves stress, one of the most common triggers for&#xD;
      the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that&#xD;
      patients with IST might benefit by practicing yoga. Yoga may also help in better rate and&#xD;
      rhythm control with yoga when employed in combination with usual medical arrangement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Determine if Yoga affects the rate and duration of IST episodes</measure>
    <time_frame>Change from Baseline to 3 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if Yoga affects the rate and duration of IST episodes</measure>
    <time_frame>Change from Baseline to 1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect yoga has on resting heart rate or occurrence of IST episodes in patients that have undergone treatment with medications and/or ablation procedures</measure>
    <time_frame>3 Months, 1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>3 Months, 1 Year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Inappropriate Sinus Tachycardia</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to practice yoga 3 days per week, at a minimum and encouraged to practice 7 days per week, for 1 year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>The subjects will be asked to practice Yoga poses at least 3 times a week at home, although daily Yoga will be encouraged. Participants will be trained in breathing exercises, postures and meditation. Each time they practice yoga will be for 1 hour and include breathing exercises, postures and meditation.</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with inappropriate sinus tachycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced malignancy or severe co-morbidities such as severe heart failure and with&#xD;
             life expectancy less than 1 year&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with unmedicated or uncontrolled high blood pressure&#xD;
&#xD;
          -  Patients with past history of Pnuemothorax&#xD;
&#xD;
          -  Patients with severe cervical spondylitis and cervical, thoracic, or lumbar disc&#xD;
             prolapse&#xD;
&#xD;
          -  Patients with carotid stenosis&#xD;
&#xD;
          -  Patients with history of psychosis (evidence of acute episodes with deep and prolonged&#xD;
             meditation) or substance abuse&#xD;
&#xD;
          -  Patients with history of epilepsy (evidence of acute episodes with deep and prolonged&#xD;
             medication)&#xD;
&#xD;
          -  Patients with glaucoma&#xD;
&#xD;
          -  Patients with history of Total Hip Replacement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>November 13, 2015</last_update_submitted>
  <last_update_submitted_qc>November 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Dhanunjaya Lakkireddy, MD, FACC</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>atrial tachycardia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Sinus</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695538
org study id: 12946
nct id: NCT01695538
lead sponsor: 
has dmc: No
Inappropriate sinus tachycardia (IST) is an uncommon form of atrial tachycardia. The term
      "inappropriate" in medicine is commonly defined as a heart rate greater than 100 beats per
      minute at rest or with minimal physiological challenge. IST is characterized by an increased
      resting heart rate with an exaggerated response to exercise or stress.

      Yoga has been used extensively around the world as an alternative medicine approach in
      treating numerous chronic and debilitating diseases. Studies have been conducted in various
      countries to determine the benefits of Yoga as therapy for these chronic diseases. Several
      studies have confirmed that yoga can reduce anxiety and regulate the stress response.

      Studies in the past have shown that Yoga relieves stress, one of the most common triggers for
      the arrhythmia and increased heart rate in IST. Based on past studies we hypothesize that
      patients with IST might benefit by practicing yoga. Yoga may also help in better rate and
      rhythm control with yoga when employed in combination with usual medical arrangement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine if Yoga affects the rate and duration of IST episodes
time frame: Change from Baseline to 3 Months
measure: Determine if Yoga affects the rate and duration of IST episodes
time frame: Change from Baseline to 1 Year
measure: Effect yoga has on resting heart rate or occurrence of IST episodes in patients that have undergone treatment with medications and/or ablation procedures
time frame: 3 Months, 1 Year
measure: Change in Quality of Life
time frame: 3 Months, 1 Year
arm group label: Yoga
arm group type: Experimental
description: Participants will be asked to practice yoga 3 days per week, at a minimum and encouraged to practice 7 days per week, for 1 year.
intervention type: Other
intervention name: Yoga
description: The subjects will be asked to practice Yoga poses at least 3 times a week at home, although daily Yoga will be encouraged. Participants will be trained in breathing exercises, postures and meditation. Each time they practice yoga will be for 1 hour and include breathing exercises, postures and meditation.
arm group label: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dhanunjaya Lakkireddy, MD, FACC
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Dhanunjaya Lakkireddy, MD, FACC
investigator title: Professor
mesh term: Tachycardia
mesh term: Tachycardia, Sinus