search
Back to results

The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

Primary Purpose

Cardiac Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrhythmias focused on measuring Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion, Anti-Tachycardia Pacing Events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
  • Must be 18 or more years of age

Exclusion Criteria:

  • Patients requiring more than 48 hours of hospitalization for implantation
  • Mental Incompetence (Dementia)
  • Physician's contra-indication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Adapted Yoga Intervention Group

    Control

    Arm 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.

    Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.

    Outcomes

    Primary Outcome Measures

    Florida Shock Anxiety Scale (FSAS)
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
    Florida Shock Anxiety Scale (FSAS)
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
    Self-Compassion Scale
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
    Self-Compassion Scale
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
    The number of device-initiated ventricular defibrillations as recorded by their ICD device
    A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
    The number of device-initiated ventricular defibrillations as recorded by their ICD device
    A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.

    Secondary Outcome Measures

    Expression Manipulation Test
    A 31-item list which tests personal and situational cue responsiveness.
    Expression Manipulation Test
    A 31-item list which tests personal and situational cue responsiveness.
    Pennebaker Inventory
    A 54-item list which tests psychological responses to physical symptoms.
    Pennebaker Inventory
    A 54-item list which tests psychological responses to physical symptoms.
    State-Trait Anxiety Inventory (STAI)
    A 30-item self report scale emphasizing dispositional states (anxiety).
    State-Trait Anxiety Inventory (STAI)
    A 30-item self report scale emphasizing dispositional states (anxiety).
    Positive Health Expectation Scale
    A 7-item list which measures positive expectations to predict health after heart transplantation.
    Positive Health Expectation Scale
    A 7-item list which measures positive expectations to predict health after heart transplantation.
    Florida Patient Acceptance Survey (FPAS)
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.
    Florida Patient Acceptance Survey (FPAS)
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.
    Center for Epidemiologic Study Depression Scale (CES-D)
    A 20-item list which is a self-report depression scale for research in the general population.
    Center for Epidemiologic Study Depression Scale (CES-D)
    A 20-item list which is a self-report depression scale for research in the general population.
    Interpersonal Support Evaluation
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
    Interpersonal Support Evaluation
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
    Hospitalizations
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Hospitalizations
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Hospitalizations
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Implantation Status
    Primary prevention and secondary prevention data from Medical Chart Review.
    Medications
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Medications
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Medications
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Co-morbidities
    Medical chart review for co-existing morbidities.
    Co-morbidities
    Medical chart review for co-existing morbidities.
    Co-morbidities
    Medical chart review for co-existing morbidities.
    Ejection Fraction
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Ejection Fraction
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Ejection Fraction
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Atrial Fibrillation
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
    Atrial Fibrillation
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
    Atrial Fibrillation
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

    Full Information

    First Posted
    October 17, 2012
    Last Updated
    October 24, 2012
    Sponsor
    Yale University
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01716351
    Brief Title
    The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
    Official Title
    The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yale University
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrhythmias
    Keywords
    Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion, Anti-Tachycardia Pacing Events

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adapted Yoga Intervention Group
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    No Intervention
    Arm 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(s)
    Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
    Intervention Description
    A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
    Primary Outcome Measure Information:
    Title
    Florida Shock Anxiety Scale (FSAS)
    Description
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
    Time Frame
    Baseline
    Title
    Florida Shock Anxiety Scale (FSAS)
    Description
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Self-Compassion Scale
    Description
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
    Time Frame
    Baseline
    Title
    Self-Compassion Scale
    Description
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
    Time Frame
    End of Intervention (8 weeks)
    Title
    The number of device-initiated ventricular defibrillations as recorded by their ICD device
    Description
    A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
    Time Frame
    Baseline
    Title
    The number of device-initiated ventricular defibrillations as recorded by their ICD device
    Description
    A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data.
    Time Frame
    Six month follow-up
    Title
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.
    Time Frame
    Baseline
    Title
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.
    Time Frame
    End of Intervention (8 weeks)
    Title
    The number of anti-tachycardia pacing events among participants as recorded by their ICD device
    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.
    Time Frame
    Six month follow-up
    Secondary Outcome Measure Information:
    Title
    Expression Manipulation Test
    Description
    A 31-item list which tests personal and situational cue responsiveness.
    Time Frame
    Baseline
    Title
    Expression Manipulation Test
    Description
    A 31-item list which tests personal and situational cue responsiveness.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Pennebaker Inventory
    Description
    A 54-item list which tests psychological responses to physical symptoms.
    Time Frame
    Baseline
    Title
    Pennebaker Inventory
    Description
    A 54-item list which tests psychological responses to physical symptoms.
    Time Frame
    End of Intervention (8 weeks)
    Title
    State-Trait Anxiety Inventory (STAI)
    Description
    A 30-item self report scale emphasizing dispositional states (anxiety).
    Time Frame
    Baseline
    Title
    State-Trait Anxiety Inventory (STAI)
    Description
    A 30-item self report scale emphasizing dispositional states (anxiety).
    Time Frame
    End of Intervention (8 weeks)
    Title
    Positive Health Expectation Scale
    Description
    A 7-item list which measures positive expectations to predict health after heart transplantation.
    Time Frame
    Baseline
    Title
    Positive Health Expectation Scale
    Description
    A 7-item list which measures positive expectations to predict health after heart transplantation.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Florida Patient Acceptance Survey (FPAS)
    Description
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.
    Time Frame
    Baseline
    Title
    Florida Patient Acceptance Survey (FPAS)
    Description
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Center for Epidemiologic Study Depression Scale (CES-D)
    Description
    A 20-item list which is a self-report depression scale for research in the general population.
    Time Frame
    Baseline
    Title
    Center for Epidemiologic Study Depression Scale (CES-D)
    Description
    A 20-item list which is a self-report depression scale for research in the general population.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Interpersonal Support Evaluation
    Description
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
    Time Frame
    Baseline
    Title
    Interpersonal Support Evaluation
    Description
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Hospitalizations
    Description
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Time Frame
    Baseline
    Title
    Hospitalizations
    Description
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Hospitalizations
    Description
    Medical Chart Review of cardiac and non-cardiac hospitalizations.
    Time Frame
    Six month follow-up
    Title
    Implantation Status
    Description
    Primary prevention and secondary prevention data from Medical Chart Review.
    Time Frame
    Baseline
    Title
    Medications
    Description
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Time Frame
    Baseline
    Title
    Medications
    Description
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Medications
    Description
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
    Time Frame
    Six month follow-up
    Title
    Co-morbidities
    Description
    Medical chart review for co-existing morbidities.
    Time Frame
    Baseline
    Title
    Co-morbidities
    Description
    Medical chart review for co-existing morbidities.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Co-morbidities
    Description
    Medical chart review for co-existing morbidities.
    Time Frame
    Six month follow-up
    Title
    Ejection Fraction
    Description
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Time Frame
    Baseline
    Title
    Ejection Fraction
    Description
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Time Frame
    End of Intervention (8 weeks)
    Title
    Ejection Fraction
    Description
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).
    Time Frame
    Six month follow-up
    Title
    Atrial Fibrillation
    Description
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
    Time Frame
    Baseline
    Title
    Atrial Fibrillation
    Description
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
    Time Frame
    End of Intervention (8 weeks)
    Title
    Atrial Fibrillation
    Description
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
    Time Frame
    Six month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more Must be 18 or more years of age Exclusion Criteria: Patients requiring more than 48 hours of hospitalization for implantation Mental Incompetence (Dementia) Physician's contra-indication
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stefanie CF Toise, PhD, MPH
    Organizational Affiliation
    Yale New Haven Hospital, St. Raphael Campus
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Thomas J Donohue, MD
    Organizational Affiliation
    Yale New Haven Hospital, St. Raphael Campus
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

    We'll reach out to this number within 24 hrs