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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Yoga Intervention Group<br>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<br>* A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.<br>|
| No Intervention: Control<br>Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Florida Shock Anxiety Scale (FSAS) | A 10-item list which measures patient fears about implantable cardioverter defibrillator shock. | Baseline | 
| Florida Shock Anxiety Scale (FSAS) | A 10-item list which measures patient fears about implantable cardioverter defibrillator shock. | 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. | Baseline | 
| Self-Compassion Scale | A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification. | 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. | 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. | 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. | Baseline | 
| 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. | 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. | Six month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression Manipulation Test | A 31-item list which tests personal and situational cue responsiveness. | Baseline | 
| Expression Manipulation Test | A 31-item list which tests personal and situational cue responsiveness. | End of Intervention (8 weeks) | 
| Pennebaker Inventory | A 54-item list which tests psychological responses to physical symptoms. | Baseline | 
| Pennebaker Inventory | A 54-item list which tests psychological responses to physical symptoms. | End of Intervention (8 weeks) | 
| State-Trait Anxiety Inventory (STAI) | A 30-item self report scale emphasizing dispositional states (anxiety). | Baseline | 
| State-Trait Anxiety Inventory (STAI) | A 30-item self report scale emphasizing dispositional states (anxiety). | End of Intervention (8 weeks) | 
| Positive Health Expectation Scale | A 7-item list which measures positive expectations to predict health after heart transplantation. | Baseline | 
| Positive Health Expectation Scale | A 7-item list which measures positive expectations to predict health after heart transplantation. | End of Intervention (8 weeks) | 
| Florida Patient Acceptance Survey (FPAS) | An 18-item list which measures patient acceptance of implantable cardiac device therapy. | Baseline | 
| Florida Patient Acceptance Survey (FPAS) | An 18-item list which measures patient acceptance of implantable cardiac device therapy. | 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. | 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. | 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. | Baseline | 
| Interpersonal Support Evaluation | A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support. | End of Intervention (8 weeks) | 
| Hospitalizations | Medical Chart Review of cardiac and non-cardiac hospitalizations. | Baseline | 
| Hospitalizations | Medical Chart Review of cardiac and non-cardiac hospitalizations. | End of Intervention (8 weeks) | 
| Hospitalizations | Medical Chart Review of cardiac and non-cardiac hospitalizations. | Six month follow-up | 
| Implantation Status | Primary prevention and secondary prevention data from Medical Chart Review. | Baseline | 
| Medications | Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts. | Baseline | 
| Medications | Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts. | End of Intervention (8 weeks) | 
| Medications | Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts. | Six month follow-up | 
| Co-morbidities | Medical chart review for co-existing morbidities. | Baseline | 
| Co-morbidities | Medical chart review for co-existing morbidities. | End of Intervention (8 weeks) | 
| Co-morbidities | Medical chart review for co-existing morbidities. | Six month follow-up | 
| Ejection Fraction | Cardiac ejection fraction measured from Electro-cardiogram (EKG). | Baseline | 
| Ejection Fraction | Cardiac ejection fraction measured from Electro-cardiogram (EKG). | End of Intervention (8 weeks) | 
| Ejection Fraction | Cardiac ejection fraction measured from Electro-cardiogram (EKG). | 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. | Baseline | 
| Atrial Fibrillation | A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review. | 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. | Six month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion, Anti-Tachycardia Pacing Events