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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
Florida Shock Anxiety Scale (FSAS)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Time frame: Baseline
Florida Shock Anxiety Scale (FSAS)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Time frame: End of Intervention (8 weeks)
Self-Compassion Scale
A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
Time frame: Baseline
Self-Compassion Scale
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)
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.
Time frame: Baseline
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.
Time frame: Six month follow-up
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.
Time frame: Baseline
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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.
Time frame: End of Intervention (8 weeks)
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.
Time frame: Six month follow-up
Expression Manipulation Test
A 31-item list which tests personal and situational cue responsiveness.
Time frame: Baseline
Expression Manipulation Test
A 31-item list which tests personal and situational cue responsiveness.
Time frame: End of Intervention (8 weeks)
Pennebaker Inventory
A 54-item list which tests psychological responses to physical symptoms.
Time frame: Baseline
Pennebaker Inventory
A 54-item list which tests psychological responses to physical symptoms.
Time frame: End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)
A 30-item self report scale emphasizing dispositional states (anxiety).
Time frame: Baseline
State-Trait Anxiety Inventory (STAI)
A 30-item self report scale emphasizing dispositional states (anxiety).
Time frame: End of Intervention (8 weeks)
Positive Health Expectation Scale
A 7-item list which measures positive expectations to predict health after heart transplantation.
Time frame: Baseline
Positive Health Expectation Scale
A 7-item list which measures positive expectations to predict health after heart transplantation.
Time frame: End of Intervention (8 weeks)
Florida Patient Acceptance Survey (FPAS)
An 18-item list which measures patient acceptance of implantable cardiac device therapy.
Time frame: Baseline
Florida Patient Acceptance Survey (FPAS)
An 18-item list which measures patient acceptance of implantable cardiac device therapy.
Time frame: End of Intervention (8 weeks)
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.
Time frame: Baseline
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.
Time frame: End of Intervention (8 weeks)
Interpersonal Support Evaluation
A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
Time frame: Baseline
Interpersonal Support Evaluation
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)
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Time frame: Baseline
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Time frame: End of Intervention (8 weeks)
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Time frame: Six month follow-up
Implantation Status
Primary prevention and secondary prevention data from Medical Chart Review.
Time frame: Baseline
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Time frame: Baseline
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Time frame: End of Intervention (8 weeks)
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Time frame: Six month follow-up
Co-morbidities
Medical chart review for co-existing morbidities.
Time frame: Baseline
Co-morbidities
Medical chart review for co-existing morbidities.
Time frame: End of Intervention (8 weeks)
Co-morbidities
Medical chart review for co-existing morbidities.
Time frame: Six month follow-up
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Time frame: Baseline
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Time frame: End of Intervention (8 weeks)
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Time frame: Six month follow-up
Atrial Fibrillation
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Time frame: Baseline
Atrial Fibrillation
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)
Atrial Fibrillation
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