Cardiac Autonomic Regulation Enhancement Through Exercise Trial

Study Overview
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Brief Summary
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The current research study proposes to examine participants with implantable cardioverter defibrillators (ICD) who are randomly assigned to either an exercise training program intervention or a heart healthy education program intervention. We will look at changes in the functioning of the autonomic nervous system over time and between intervention groups. We are also going to be looking at changes in frequencies of the ICD participants' heart arrhythmias and ICD therapies (e.g., pacing, shock).; as well as, changes in exercise tolerance, psychological well-being, and quality of life.

Official Title
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Cardiac Autonomic Regulation Enhancement Through Exercise Trial

Conditions
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Cardiovascular Disease, Arrhythmias

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Heart Healthy Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult ICD patients (≥ 18 years of age) received an ICD for secondary prevention, cardiac diagnosis of: ventricular fibrillation, OR ventricular tachycardia, OR cardiac arrest, OR syncope with ventricular tachycardia inducible by programmed stimulation (EPS), AND either diagnosed coronary artery disease AND/OR prior myocardial infarction, or non-ischemic dilated cardiomyopathy meet functional NYHA Class I or II heart failure or angina symptoms ICD patients need to be sedentary, defined as not engaging in structured exercise more than once weekly, or an accumulation of less than 60 minutes of moderate intensity aerobic activity over the course of the week, for the past 3 months. deemed medically stable by their cardiologist and have received approval by their cardiologist to engage in an exercise program Stable (unchanged) cardiac and psychopharmacologic medications in the 3 months prior to study enrollment Able to read and write English able to commit to the 3-month exercise/heart healthy program attending 3 times per week (36 sessions) able to commit to the 3 assessments (pre, post-treatment, 3-month follow-up; 6-month duration) Exclusion Criteria: Patients who meet functional NYHA Class III or IV heart failure or angina symptoms sinus node dysfunction that requires atrial pacing atrial fibrillation bi-ventricular ICD are pacemaker-dependent diagnosis of Brugada's Syndrome diagnosis of arrhythmogenic right ventricular dysplasia complex congenital heart disease orthopedic restrictions, limitations, or disabilities that would jeopardize the patient's safety during exercise or form completing the treadmill stress test Neurocognitive or cognitive impairments that will result in nonadherence (based on clinical evaluation) Unstable angina resting systolic blood pressure >180mmHg or resting diastolic blood pressure >110mm Hg will be evaluated on a case-by-case basis orthostatic blood pressure drop of >20mm Hg with symptoms critical aortic stenosis (peak systolic pressure gradient >50mm Hg with aortic valve orifice area <0.75cm2 in average size adult) acute systemic illness or fever uncontrolled atrial or ventricular arrhythmias uncontrolled sinus tachycardia (>120 beats/min) uncompensated CHF 3rd degree AV block (without pacemaker) active pericarditis or myocarditis recent embolism; thrombophlebitis resting ST segment displacement (>2mm) uncontrolled diabetes (resting blood glucose >400mg/dl) metabolic problems, such as acute, hypo or hyperkalemia, hypovolemia recent strongly positive exercise test as achieved by: significant decrease in systolic blood pressure with increasing workload, OR early onset, horizontal or downsloping ST segment depression (4mm), OR prolonged electrocardiogram (ECG) changes during recovery hypertrophic obstructive cardiomyopathy severe pulmonary hypertension patients who do not pass the exercise stress test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>moderate-intensity, low-impact, supervised, aerobic exercise | Behavioral: Exercise<br>* moderate-intensity, low-impact, supervised, aerobic exercise<br>|
| Active Comparator: Heart Healthy Education<br>Educational topics on heart health (e.g., nutrition, smoking, sleep) | Behavioral: Heart Healthy Education<br>* Educational topics related to heart health (e.g., nutrition, smoking, sleep)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parasympathetic activity and regulation |  | 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrhythmia frequency |  | 3 months, 6 months | 
| ICD therapy frequency |  | 3 months, 6 months | 
| exercise tolerance |  | 3 months, 6 months | 
| psychological well-being |  | 3 months, 6 months | 
| quality of life |  | 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parasympathetic activity, Exercise, Education, Arrhythmias, Defibrillators, Implantable