Cardiac ArrhythmiasNCT01716351
The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
A study testing Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients in people with Cardiac Arrhythmias, run by Yale University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
- Must be 18 or more years of age
Who cannot join
- Patients requiring more than 48 hours of hospitalization for implantation
- Mental Incompetence (Dementia)
- Physician's contra-indication
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
- Keywords
- Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion, Anti-Tachycardia Pacing Events
- Medical subject headings
- Arrhythmias, Cardiac, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) RecipientsBehavioural
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Yoga Intervention Group | Experimental | 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. Receives: Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients |
| Control | No intervention | Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Florida Shock Anxiety Scale (FSAS)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Measured: Baseline
Florida Shock Anxiety Scale (FSAS)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Measured: 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.
Measured: Baseline
Self-Compassion Scale
A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six month follow-up
Secondary outcomes (30)
Expression Manipulation Test
A 31-item list which tests personal and situational cue responsiveness.
Measured: Baseline
Expression Manipulation Test
A 31-item list which tests personal and situational cue responsiveness.
Measured: End of Intervention (8 weeks)
Pennebaker Inventory
A 54-item list which tests psychological responses to physical symptoms.
Measured: Baseline
Pennebaker Inventory
A 54-item list which tests psychological responses to physical symptoms.
Measured: End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)
A 30-item self report scale emphasizing dispositional states (anxiety).
Measured: Baseline
State-Trait Anxiety Inventory (STAI)
A 30-item self report scale emphasizing dispositional states (anxiety).
Measured: End of Intervention (8 weeks)
Positive Health Expectation Scale
A 7-item list which measures positive expectations to predict health after heart transplantation.
Measured: Baseline
Positive Health Expectation Scale
A 7-item list which measures positive expectations to predict health after heart transplantation.
Measured: End of Intervention (8 weeks)
Florida Patient Acceptance Survey (FPAS)
An 18-item list which measures patient acceptance of implantable cardiac device therapy.
Measured: Baseline
Florida Patient Acceptance Survey (FPAS)
An 18-item list which measures patient acceptance of implantable cardiac device therapy.
Measured: End of Intervention (8 weeks)
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.
Measured: Baseline
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.
Measured: End of Intervention (8 weeks)
Interpersonal Support Evaluation
A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
Measured: Baseline
Interpersonal Support Evaluation
A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support.
Measured: End of Intervention (8 weeks)
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Measured: Baseline
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Measured: End of Intervention (8 weeks)
Hospitalizations
Medical Chart Review of cardiac and non-cardiac hospitalizations.
Measured: Six month follow-up
Implantation Status
Primary prevention and secondary prevention data from Medical Chart Review.
Measured: Baseline
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Measured: Baseline
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Measured: End of Intervention (8 weeks)
Medications
Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts.
Measured: Six month follow-up
Co-morbidities
Medical chart review for co-existing morbidities.
Measured: Baseline
Co-morbidities
Medical chart review for co-existing morbidities.
Measured: End of Intervention (8 weeks)
Co-morbidities
Medical chart review for co-existing morbidities.
Measured: Six month follow-up
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Measured: Baseline
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Measured: End of Intervention (8 weeks)
Ejection Fraction
Cardiac ejection fraction measured from Electro-cardiogram (EKG).
Measured: Six month follow-up
Atrial Fibrillation
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Measured: Baseline
Atrial Fibrillation
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Measured: End of Intervention (8 weeks)
Atrial Fibrillation
A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review.
Measured: Six month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startAug 2007
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Stefanie Toise, Yale University
- Investigators
- Stefanie CF Toise, PhD, MPH, Principal investigator, Yale New Haven Hospital, St. Raphael CampusThomas J Donohue, MD, Study director, Yale New Haven Hospital, St. Raphael Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716351
- Sponsor's protocol ID
- #SR-1569
- Other IDs
- F31AT003757
- Status last verified
- Oct 2012
- First submitted
- 17 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
- ClinicalTrials.gov ID
- NCT01716351
- Acronym / sponsor ID
- #SR-1569
- Conditions
- Cardiac Arrhythmias
- Keywords
- Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Yoga Intervention Group | Experimental | Behavioral: Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) RecipientsPatients 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 intervention | –Patients received usual care and a call from a cardiac research nurse once monthly for five months to control for attention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
- Must be 18 or more years of age
Key exclusion criteria (3 listed)
- Patients requiring more than 48 hours of hospitalization for implantation
- Mental Incompetence (Dementia)
- Physician's contra-indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) RecipientsA weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD. | Behavioural | Adapted Yoga Intervention Group |
Primary outcome
Florida Shock Anxiety Scale (FSAS)
Time frame: Baseline
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
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.
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.
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.
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.
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.
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.
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.
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.
30 secondary outcomes
Expression Manipulation Test
Time frame: Baseline
Expression Manipulation Test
Time frame: End of Intervention (8 weeks)
Pennebaker Inventory
Time frame: Baseline
Pennebaker Inventory
Time frame: End of Intervention (8 weeks)
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline
State-Trait Anxiety Inventory (STAI)
Time frame: End of Intervention (8 weeks)
Positive Health Expectation Scale
Time frame: Baseline
Positive Health Expectation Scale
Time frame: End of Intervention (8 weeks)
Florida Patient Acceptance Survey (FPAS)
Time frame: Baseline
Florida Patient Acceptance Survey (FPAS)
Time frame: End of Intervention (8 weeks)
Center for Epidemiologic Study Depression Scale (CES-D)
Time frame: Baseline
Center for Epidemiologic Study Depression Scale (CES-D)
Time frame: End of Intervention (8 weeks)
Interpersonal Support Evaluation
Time frame: Baseline
Interpersonal Support Evaluation
Time frame: End of Intervention (8 weeks)
Hospitalizations
Time frame: Baseline
Hospitalizations
Time frame: End of Intervention (8 weeks)
Hospitalizations
Time frame: Six month follow-up
Implantation Status
Time frame: Baseline
Medications
Time frame: Baseline
Medications
Time frame: End of Intervention (8 weeks)
Medications
Time frame: Six month follow-up
Co-morbidities
Time frame: Baseline
Co-morbidities
Time frame: End of Intervention (8 weeks)
Co-morbidities
Time frame: Six month follow-up
Ejection Fraction
Time frame: Baseline
Ejection Fraction
Time frame: End of Intervention (8 weeks)
Ejection Fraction
Time frame: Six month follow-up
Atrial Fibrillation
Time frame: Baseline
Atrial Fibrillation
Time frame: End of Intervention (8 weeks)
Atrial Fibrillation
Time frame: Six month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie CF Toise, PhD, MPH principal investigator
Yale New Haven Hospital, St. Raphael Campus
Thomas J Donohue, MD study director
Yale New Haven Hospital, St. Raphael Campus
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients in people with Cardiac Arrhythmias, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Florida Shock Anxiety Scale (FSAS) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.