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Randomized Controlled Trial
. 2014 Jan;37(1):48-62.
doi: 10.1111/pace.12252. Epub 2013 Aug 26.

Psychosocial and cardiac outcomes of yoga for ICD patients: a randomized clinical control trial

Stefanie C F Toise  1 , Samuel F Sears, Mark H Schoenfeld, Mark L Blitzer, Mark A Marieb, John H Drury, Martin D Slade, Thomas J Donohue
Affiliations
Randomized Controlled Trial

Psychosocial and cardiac outcomes of yoga for ICD patients: a randomized clinical control trial

Stefanie C F Toise et al. Pacing Clin Electrophysiol. 2014 Jan.

Abstract

Background: Because as many as 46% of implantable cardioverter defibrillator (ICD) patients experience clinical symptoms of shock anxiety, this randomized controlled study evaluated the efficacy of adapted yoga (vs usual care) in reducing clinical psychosocial risks shown to impact morbidity and mortality in ICD recipients.

Methods: Forty-six participants were randomized to a control group or an 8-week adapted yoga group that followed a standardized protocol with weekly classes and home practice. Medical and psychosocial data were collected at baseline and follow-up, then compared and analyzed.

Results: Total shock anxiety decreased for the yoga group and increased for the control group, t(4.43, 36), P < 0.0001, with significant differences between these changes. Similarly, consequential anxiety decreased for the yoga group but increased for the control group t(2.86,36) P = 0.007. Compared to the control, the yoga group had greater overall self-compassion, t(-2.84,37), P = 0.007, and greater mindfulness, t(-2.10,37) P = 0.04, at the end of the study. Exploratory analyses utilizing a linear model (R(2) = 0.98) of observed device-treated ventricular (DTV) events revealed that the expected number of DTV events in the yoga group was significantly lower than in the control group (P < 0.0001). Compared to the control, the yoga group had a 32% lower risk of experiencing device-related firings at end of follow-up.

Conclusions: Our study demonstrated psychosocial benefits from a program of adapted yoga (vs usual care) for ICD recipients. These data support continued research to better understand the role of complementary medicine to address ICD-specific stress in cardiac outcomes.

Keywords: electrophysiology; implantable cardioverter defibrillator (ICD); psychosocial risk; quality of life; randomized clinical trials; yoga.

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Conflict of interest statement

Disclosures: Dr. Sears consults with and has research grants from Medtronic. All funds from Medtronic are directed to East Carolina University. He has received speaker honoraria from Medtronic, Boston Scientific, St. Jude Medical, and Biotronik.

Figures

Figure 1
Figure 1
Study design flowchart
Figure 2
Figure 2
Participant flow diagram
Figure 3
Figure 3
T-tests comparing mean change from baseline to post-test; (top left) T-test comparing mean change of Florida Shock Anxiety Scale (FSAS) Total from baseline to post-test; (top right) T-test comparing mean change of Florida Shock Anxiety Scale (FSAS) Mean Consequence from baseline to post-test; (bottom left)T-test comparing mean change of Self-Compassion Scale (SCS) Total from baseline to post-test; (bottom right)T-test comparing mean change of Self-Compassion Scale (SCS) Mindfulness from baseline to post-test.
Figure 4
Figure 4
Generalized linear model of expected number of device-treated pacing events (DTV events) Sixty Year Old Male R2=0.98 Dotted line=95% confidence interval T1= week 1 T2=week 8 + six month follow-up period
See this image and copyright information in PMC

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