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

October 24, 2012 updated by: Stefanie Toise, Yale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Adapted Yoga Intervention Group
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
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
NO_INTERVENTION: Control
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Florida Shock Anxiety Scale (FSAS)
Time Frame: Baseline
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Baseline
Florida Shock Anxiety Scale (FSAS)
Time Frame: End of Intervention (8 weeks)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
End of Intervention (8 weeks)
Self-Compassion Scale
Time Frame: Baseline
A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
Baseline
Self-Compassion Scale
Time Frame: End of Intervention (8 weeks)
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
Time Frame: Baseline
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
Time Frame: Six month follow-up
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
Time Frame: Baseline
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
Time Frame: End of Intervention (8 weeks)
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
Time Frame: Six month follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expression Manipulation Test
Time Frame: Baseline
A 31-item list which tests personal and situational cue responsiveness.
Baseline
Expression Manipulation Test
Time Frame: End of Intervention (8 weeks)
A 31-item list which tests personal and situational cue responsiveness.
End of Intervention (8 weeks)
Pennebaker Inventory
Time Frame: Baseline
A 54-item list which tests psychological responses to physical symptoms.
Baseline
Pennebaker Inventory
Time Frame: End of Intervention (8 weeks)
A 54-item list which tests psychological responses to physical symptoms.
End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline
A 30-item self report scale emphasizing dispositional states (anxiety).
Baseline
State-Trait Anxiety Inventory (STAI)
Time Frame: End of Intervention (8 weeks)
A 30-item self report scale emphasizing dispositional states (anxiety).
End of Intervention (8 weeks)
Positive Health Expectation Scale
Time Frame: Baseline
A 7-item list which measures positive expectations to predict health after heart transplantation.
Baseline
Positive Health Expectation Scale
Time Frame: End of Intervention (8 weeks)
A 7-item list which measures positive expectations to predict health after heart transplantation.
End of Intervention (8 weeks)
Florida Patient Acceptance Survey (FPAS)
Time Frame: Baseline
An 18-item list which measures patient acceptance of implantable cardiac device therapy.
Baseline
Florida Patient Acceptance Survey (FPAS)
Time Frame: End of Intervention (8 weeks)
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)
Time Frame: Baseline
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)
Time Frame: End of Intervention (8 weeks)
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
Time Frame: Baseline
A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
Baseline
Interpersonal Support Evaluation
Time Frame: End of Intervention (8 weeks)
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
Time Frame: Baseline
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Baseline
Hospitalizations
Time Frame: End of Intervention (8 weeks)
Medical Chart Review of cardiac and non-cardiac hospitalizations.
End of Intervention (8 weeks)
Hospitalizations
Time Frame: Six month follow-up
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Six month follow-up
Implantation Status
Time Frame: Baseline
Primary prevention and secondary prevention data from Medical Chart Review.
Baseline
Medications
Time Frame: Baseline
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Baseline
Medications
Time Frame: End of Intervention (8 weeks)
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
End of Intervention (8 weeks)
Medications
Time Frame: Six month follow-up
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Six month follow-up
Co-morbidities
Time Frame: Baseline
Medical chart review for co-existing morbidities.
Baseline
Co-morbidities
Time Frame: End of Intervention (8 weeks)
Medical chart review for co-existing morbidities.
End of Intervention (8 weeks)
Co-morbidities
Time Frame: Six month follow-up
Medical chart review for co-existing morbidities.
Six month follow-up
Ejection Fraction
Time Frame: Baseline
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Baseline
Ejection Fraction
Time Frame: End of Intervention (8 weeks)
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
End of Intervention (8 weeks)
Ejection Fraction
Time Frame: Six month follow-up
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Six month follow-up
Atrial Fibrillation
Time Frame: Baseline
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Baseline
Atrial Fibrillation
Time Frame: End of Intervention (8 weeks)
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
Time Frame: Six month follow up
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Six month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #SR-1569
  • F31AT003757 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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