The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
2 other identifiers
interventional
55
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedOctober 29, 2012
October 1, 2012
3.3 years
October 17, 2012
October 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (30)
Expression Manipulation Test
Baseline
Expression Manipulation Test
End of Intervention (8 weeks)
Pennebaker Inventory
Baseline
Pennebaker Inventory
End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)
Baseline
- +25 more secondary outcomes
Study Arms (2)
Adapted Yoga Intervention Group
EXPERIMENTALPatients received the Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients and a call from a cardiac research nurse once monthly for five months.
Control
NO INTERVENTIONPatients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention.
Interventions
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
Eligibility Criteria
You may qualify if:
- Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
- Must be 18 or more years of age
You may not qualify if:
- Patients requiring more than 48 hours of hospitalization for implantation
- Mental Incompetence (Dementia)
- Physician's contra-indication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefanie CF Toise, PhD, MPH
Yale New Haven Hospital, St. Raphael Campus
- STUDY DIRECTOR
Thomas J Donohue, MD
Yale New Haven Hospital, St. Raphael Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 29, 2012
Study Start
August 1, 2007
Primary Completion
November 1, 2010
Study Completion
February 1, 2011
Last Updated
October 29, 2012
Record last verified: 2012-10