<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/NCT01716351</url>
  </required_header>
  <id_info>
    <org_study_id>#SR-1569</org_study_id>
    <secondary_id>F31AT003757</secondary_id>
    <nct_id>NCT01716351</nct_id>
  </id_info>
  <brief_title>The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients</brief_title>
  <official_title>The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psychosocial risks are significant in the management of patients with cardiovascular disease&#xD;
      and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled,&#xD;
      clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly&#xD;
      reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of&#xD;
      life in ICD patients. The specialized, real-time data, collected by the device provides a&#xD;
      unique look at the electrophysiological parameters of each patient's heart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All intervention data will be analyzed to determine the statistical significance of the data,&#xD;
      and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental&#xD;
      interviews with patients who have lived with the implantable cardioverter defibrillator (ICD)&#xD;
      device for at least six months and who are not in the intervention. The qualitative data&#xD;
      gathered from these interviews will document concepts of illness and healing and general&#xD;
      beliefs about mind-body interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Florida Shock Anxiety Scale (FSAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Florida Shock Anxiety Scale (FSAS)</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Compassion Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Compassion Scale</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of device-initiated ventricular defibrillations as recorded by their ICD device</measure>
    <time_frame>Baseline</time_frame>
    <description>A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of device-initiated ventricular defibrillations as recorded by their ICD device</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of anti-tachycardia pacing events among participants as recorded by their ICD device</measure>
    <time_frame>Baseline</time_frame>
    <description>As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of anti-tachycardia pacing events among participants as recorded by their ICD device</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of anti-tachycardia pacing events among participants as recorded by their ICD device</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expression Manipulation Test</measure>
    <time_frame>Baseline</time_frame>
    <description>A 31-item list which tests personal and situational cue responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression Manipulation Test</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 31-item list which tests personal and situational cue responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pennebaker Inventory</measure>
    <time_frame>Baseline</time_frame>
    <description>A 54-item list which tests psychological responses to physical symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pennebaker Inventory</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 54-item list which tests psychological responses to physical symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>Baseline</time_frame>
    <description>A 30-item self report scale emphasizing dispositional states (anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 30-item self report scale emphasizing dispositional states (anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Health Expectation Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>A 7-item list which measures positive expectations to predict health after heart transplantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Health Expectation Scale</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 7-item list which measures positive expectations to predict health after heart transplantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Florida Patient Acceptance Survey (FPAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>An 18-item list which measures patient acceptance of implantable cardiac device therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Florida Patient Acceptance Survey (FPAS)</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>An 18-item list which measures patient acceptance of implantable cardiac device therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Study Depression Scale (CES-D)</measure>
    <time_frame>Baseline</time_frame>
    <description>A 20-item list which is a self-report depression scale for research in the general population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Study Depression Scale (CES-D)</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 20-item list which is a self-report depression scale for research in the general population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Support Evaluation</measure>
    <time_frame>Baseline</time_frame>
    <description>A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Support Evaluation</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>Baseline</time_frame>
    <description>Medical Chart Review of cardiac and non-cardiac hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>Medical Chart Review of cardiac and non-cardiac hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>Medical Chart Review of cardiac and non-cardiac hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation Status</measure>
    <time_frame>Baseline</time_frame>
    <description>Primary prevention and secondary prevention data from Medical Chart Review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications</measure>
    <time_frame>Baseline</time_frame>
    <description>Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbidities</measure>
    <time_frame>Baseline</time_frame>
    <description>Medical chart review for co-existing morbidities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbidities</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>Medical chart review for co-existing morbidities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbidities</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>Medical chart review for co-existing morbidities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ejection Fraction</measure>
    <time_frame>Baseline</time_frame>
    <description>Cardiac ejection fraction measured from Electro-cardiogram (EKG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ejection Fraction</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>Cardiac ejection fraction measured from Electro-cardiogram (EKG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ejection Fraction</measure>
    <time_frame>Six month follow-up</time_frame>
    <description>Cardiac ejection fraction measured from Electro-cardiogram (EKG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Fibrillation</measure>
    <time_frame>Baseline</time_frame>
    <description>A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Fibrillation</measure>
    <time_frame>End of Intervention (8 weeks)</time_frame>
    <description>A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Fibrillation</measure>
    <time_frame>Six month follow up</time_frame>
    <description>A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Cardiac Arrhythmias</condition>
  <arm_group>
    <arm_group_label>Adapted Yoga Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received the Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients and a call from a cardiac research nurse once monthly for five months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients</intervention_name>
    <description>A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.</description>
    <arm_group_label>Adapted Yoga Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more&#xD;
&#xD;
          -  Must be 18 or more years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients requiring more than 48 hours of hospitalization for implantation&#xD;
&#xD;
          -  Mental Incompetence (Dementia)&#xD;
&#xD;
          -  Physician's contra-indication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefanie CF Toise, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale New Haven Hospital, St. Raphael Campus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas J Donohue, MD</last_name>
    <role>Study Director</role>
    <affiliation>Yale New Haven Hospital, St. Raphael Campus</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Stefanie Toise</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Randomized Clinical Control Trial</keyword>
  <keyword>Complementary and Alternative Medicine</keyword>
  <keyword>Yoga</keyword>
  <keyword>Electrophysiology</keyword>
  <keyword>Implantable Cardioverter Defibrillator</keyword>
  <keyword>Psychosocial</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Self-Compassion</keyword>
  <keyword>Anti-Tachycardia Pacing Events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT01716351
org study id: #SR-1569
secondary id: F31AT003757
nct id: NCT01716351
lead sponsor: 
collaborator: 
has dmc: No
Psychosocial risks are significant in the management of patients with cardiovascular disease
      and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled,
      clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly
      reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of
      life in ICD patients. The specialized, real-time data, collected by the device provides a
      unique look at the electrophysiological parameters of each patient's heart.
All intervention data will be analyzed to determine the statistical significance of the data,
      and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental
      interviews with patients who have lived with the implantable cardioverter defibrillator (ICD)
      device for at least six months and who are not in the intervention. The qualitative data
      gathered from these interviews will document concepts of illness and healing and general
      beliefs about mind-body interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Florida Shock Anxiety Scale (FSAS)
time frame: Baseline
description: A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
measure: Florida Shock Anxiety Scale (FSAS)
time frame: End of Intervention (8 weeks)
description: A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
measure: Self-Compassion Scale
time frame: Baseline
description: A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
measure: Self-Compassion Scale
time frame: End of Intervention (8 weeks)
description: A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
measure: The number of device-initiated ventricular defibrillations as recorded by their ICD device
time frame: Baseline
description: A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
measure: The number of device-initiated ventricular defibrillations as recorded by their ICD device
time frame: Six month follow-up
description: A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
time frame: Baseline
description: As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
time frame: End of Intervention (8 weeks)
description: As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.
measure: The number of anti-tachycardia pacing events among participants as recorded by their ICD device
time frame: Six month follow-up
description: As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant.
measure: Expression Manipulation Test
time frame: Baseline
description: A 31-item list which tests personal and situational cue responsiveness.
measure: Expression Manipulation Test
time frame: End of Intervention (8 weeks)
description: A 31-item list which tests personal and situational cue responsiveness.
measure: Pennebaker Inventory
time frame: Baseline
description: A 54-item list which tests psychological responses to physical symptoms.
measure: Pennebaker Inventory
time frame: End of Intervention (8 weeks)
description: A 54-item list which tests psychological responses to physical symptoms.
measure: State-Trait Anxiety Inventory (STAI)
time frame: Baseline
description: A 30-item self report scale emphasizing dispositional states (anxiety).
measure: State-Trait Anxiety Inventory (STAI)
time frame: End of Intervention (8 weeks)
description: A 30-item self report scale emphasizing dispositional states (anxiety).
measure: Positive Health Expectation Scale
time frame: Baseline
description: A 7-item list which measures positive expectations to predict health after heart transplantation.
measure: Positive Health Expectation Scale
time frame: End of Intervention (8 weeks)
description: A 7-item list which measures positive expectations to predict health after heart transplantation.
measure: Florida Patient Acceptance Survey (FPAS)
time frame: Baseline
description: An 18-item list which measures patient acceptance of implantable cardiac device therapy.
measure: Florida Patient Acceptance Survey (FPAS)
time frame: End of Intervention (8 weeks)
description: An 18-item list which measures patient acceptance of implantable cardiac device therapy.
measure: Center for Epidemiologic Study Depression Scale (CES-D)
time frame: Baseline
description: A 20-item list which is a self-report depression scale for research in the general population.
measure: Center for Epidemiologic Study Depression Scale (CES-D)
time frame: End of Intervention (8 weeks)
description: A 20-item list which is a self-report depression scale for research in the general population.
measure: Interpersonal Support Evaluation
time frame: Baseline
description: A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
measure: Interpersonal Support Evaluation
time frame: End of Intervention (8 weeks)
description: A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
measure: Hospitalizations
time frame: Baseline
description: Medical Chart Review of cardiac and non-cardiac hospitalizations.
measure: Hospitalizations
time frame: End of Intervention (8 weeks)
description: Medical Chart Review of cardiac and non-cardiac hospitalizations.
measure: Hospitalizations
time frame: Six month follow-up
description: Medical Chart Review of cardiac and non-cardiac hospitalizations.
measure: Implantation Status
time frame: Baseline
description: Primary prevention and secondary prevention data from Medical Chart Review.
measure: Medications
time frame: Baseline
description: Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
measure: Medications
time frame: End of Intervention (8 weeks)
description: Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
measure: Medications
time frame: Six month follow-up
description: Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
measure: Co-morbidities
time frame: Baseline
description: Medical chart review for co-existing morbidities.
measure: Co-morbidities
time frame: End of Intervention (8 weeks)
description: Medical chart review for co-existing morbidities.
measure: Co-morbidities
time frame: Six month follow-up
description: Medical chart review for co-existing morbidities.
measure: Ejection Fraction
time frame: Baseline
description: Cardiac ejection fraction measured from Electro-cardiogram (EKG).
measure: Ejection Fraction
time frame: End of Intervention (8 weeks)
description: Cardiac ejection fraction measured from Electro-cardiogram (EKG).
measure: Ejection Fraction
time frame: Six month follow-up
description: Cardiac ejection fraction measured from Electro-cardiogram (EKG).
measure: Atrial Fibrillation
time frame: Baseline
description: A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
measure: Atrial Fibrillation
time frame: End of Intervention (8 weeks)
description: A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
measure: Atrial Fibrillation
time frame: Six month follow up
description: A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
arm group label: Adapted Yoga Intervention Group
arm group type: Experimental
description: Patients received the Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients and a call from a cardiac research nurse once monthly for five months.
arm group label: Control
arm group type: No Intervention
description: Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.
intervention type: Behavioral
intervention name: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
description: A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
arm group label: Adapted Yoga Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefanie CF Toise, PhD, MPH
role: Principal Investigator
affiliation: Yale New Haven Hospital, St. Raphael Campus
last name: Thomas J Donohue, MD
role: Study Director
affiliation: Yale New Haven Hospital, St. Raphael Campus
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Stefanie Toise
investigator title: Principal Investigator
mesh term: Arrhythmias, Cardiac