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

Yale University

Status: Completed

Conditions: Cardiac Arrhythmias

Treatments: Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01716351

F31AT003757 (U.S. NIH Grant/Contract)

#SR-1569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Adapted Yoga Intervention Group

Experimental group

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.

Treatment:

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

Control

No Intervention group

Description:

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