Cardiac Autonomic Regulation Enhancement Through Exercise Trial (CARE-E)

Lifespan

Status and phase

Completed

Phase 1

Conditions

Cardiovascular Disease, Arrhythmias

Treatments

Behavioral: Exercise

Behavioral: Heart Healthy Education

Study type

Interventional

Funder types

Other

Identifiers

NCT00845091

HL092340

R21HL092340-01A1 (U.S. NIH Grant/Contract)

RIH IRB, CMTT: 0177-08

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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