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

Cardiac Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716351
• Other study ID #: #SR-1569
• Secondary ID: F31AT003757
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: October 24, 2012
• Start date: August 2007
• Est. completion date: February 2011

Study information

• Verified date: October 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Florida Shock Anxiety Scale (FSAS)	A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.	Baseline	No
Primary	Florida Shock Anxiety Scale (FSAS)	A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.	End of Intervention (8 weeks)	No
Primary	Self-Compassion Scale	A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.	Baseline	No
Primary	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)	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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)	No
Primary	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	No
Secondary	Expression Manipulation Test	A 31-item list which tests personal and situational cue responsiveness.	Baseline	No
Secondary	Expression Manipulation Test	A 31-item list which tests personal and situational cue responsiveness.	End of Intervention (8 weeks)	No
Secondary	Pennebaker Inventory	A 54-item list which tests psychological responses to physical symptoms.	Baseline	No
Secondary	Pennebaker Inventory	A 54-item list which tests psychological responses to physical symptoms.	End of Intervention (8 weeks)	No
Secondary	State-Trait Anxiety Inventory (STAI)	A 30-item self report scale emphasizing dispositional states (anxiety).	Baseline	No
Secondary	State-Trait Anxiety Inventory (STAI)	A 30-item self report scale emphasizing dispositional states (anxiety).	End of Intervention (8 weeks)	No
Secondary	Positive Health Expectation Scale	A 7-item list which measures positive expectations to predict health after heart transplantation.	Baseline	No
Secondary	Positive Health Expectation Scale	A 7-item list which measures positive expectations to predict health after heart transplantation.	End of Intervention (8 weeks)	No
Secondary	Florida Patient Acceptance Survey (FPAS)	An 18-item list which measures patient acceptance of implantable cardiac device therapy.	Baseline	No
Secondary	Florida Patient Acceptance Survey (FPAS)	An 18-item list which measures patient acceptance of implantable cardiac device therapy.	End of Intervention (8 weeks)	No
Secondary	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	No
Secondary	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)	No
Secondary	Interpersonal Support Evaluation	A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.	Baseline	No
Secondary	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)	No
Secondary	Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	Baseline	No
Secondary	Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	End of Intervention (8 weeks)	No
Secondary	Hospitalizations	Medical Chart Review of cardiac and non-cardiac hospitalizations.	Six month follow-up	No
Secondary	Implantation Status	Primary prevention and secondary prevention data from Medical Chart Review.	Baseline	No
Secondary	Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	Baseline	No
Secondary	Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	End of Intervention (8 weeks)	No
Secondary	Medications	Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.	Six month follow-up	No
Secondary	Co-morbidities	Medical chart review for co-existing morbidities.	Baseline	No
Secondary	Co-morbidities	Medical chart review for co-existing morbidities.	End of Intervention (8 weeks)	No
Secondary	Co-morbidities	Medical chart review for co-existing morbidities.	Six month follow-up	No
Secondary	Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	Baseline	No
Secondary	Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	End of Intervention (8 weeks)	No
Secondary	Ejection Fraction	Cardiac ejection fraction measured from Electro-cardiogram (EKG).	Six month follow-up	No
Secondary	Atrial Fibrillation	A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.	Baseline	No
Secondary	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)	No
Secondary	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	No