Cardiac Autonomic Regulation Enhancement Through Exercise Trial

The Miriam Hospital1 site in 1 country22 target enrollmentFebruary 2009

ConditionsCardiovascular Disease, Arrhythmias

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cardiovascular Disease, Arrhythmias
Sponsor: The Miriam Hospital
Enrollment: 22
Locations: 1
Primary Endpoint: parasympathetic activity and regulation
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

July 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Miriam Hospital

Responsible Party

Principal Investigator

Eva R. Serber

Assistant Professor (Research)

The Miriam Hospital

Eligibility Criteria

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)