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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Stefanie Toise, Yale University
ClinicalTrials.gov Identifier:
NCT01716351
First received: October 17, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Arrhythmias
 Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Florida Shock Anxiety Scale (FSAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.

  • Florida Shock Anxiety Scale (FSAS) [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.

  • Self-Compassion Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.

  • Self-Compassion Scale [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 31-item list which tests personal and situational cue responsiveness.

  • Expression Manipulation Test [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 31-item list which tests personal and situational cue responsiveness.

  • Pennebaker Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 54-item list which tests psychological responses to physical symptoms.

  • Pennebaker Inventory [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 54-item list which tests psychological responses to physical symptoms.

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 30-item self report scale emphasizing dispositional states (anxiety).

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 30-item self report scale emphasizing dispositional states (anxiety).

  • Positive Health Expectation Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 7-item list which measures positive expectations to predict health after heart transplantation.

  • Positive Health Expectation Scale [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 7-item list which measures positive expectations to predict health after heart transplantation.

  • Florida Patient Acceptance Survey (FPAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.

  • Florida Patient Acceptance Survey (FPAS) [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    An 18-item list which measures patient acceptance of implantable cardiac device therapy.

  • Center for Epidemiologic Study Depression Scale (CES-D) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 20-item list which is a self-report depression scale for research in the general population.

  • Interpersonal Support Evaluation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.

  • Interpersonal Support Evaluation [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.

  • Hospitalizations [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Hospitalizations [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Hospitalizations [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    Medical Chart Review of cardiac and non-cardiac hospitalizations.

  • Implantation Status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Primary prevention and secondary prevention data from Medical Chart Review.

  • Medications [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Medications [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Medications [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.

  • Co-morbidities [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Medical chart review for co-existing morbidities.

  • Co-morbidities [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    Medical chart review for co-existing morbidities.

  • Co-morbidities [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    Medical chart review for co-existing morbidities.

  • Ejection Fraction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Ejection Fraction [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Ejection Fraction [ Time Frame: Six month follow-up ] [ Designated as safety issue: No ]
    Cardiac ejection fraction measured from Electro-cardiogram (EKG).

  • Atrial Fibrillation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

  • Atrial Fibrillation [ Time Frame: End of Intervention (8 weeks) ] [ Designated as safety issue: No ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.

  • Atrial Fibrillation [ Time Frame: Six month follow up ] [ Designated as safety issue: No ]
    A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.


Enrollment: 55
Study Start Date: August 2007
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adapted Yoga Intervention Group
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.
 Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
No Intervention: Control
Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716351

Sponsors and Collaborators
Yale University
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Stefanie CF Toise, PhD, MPH Yale New Haven Hospital, St. Raphael Campus
Study Director: Thomas J Donohue, MD Yale New Haven Hospital, St. Raphael Campus
  More Information

No publications provided

Responsible Party: Stefanie Toise, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01716351     History of Changes
Other Study ID Numbers: #SR-1569, F31AT003757
Study First Received: October 17, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Randomized Clinical Control Trial
Complementary and Alternative Medicine
Yoga
Electrophysiology
Implantable Cardioverter Defibrillator
 Psychosocial
Anxiety
Self-Compassion
Anti-Tachycardia Pacing Events

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013