Clinical trial NCT00845091: Cardiac Autonomic Regulation Enhancement Through Exercise Trial
Official title: Cardiac Autonomic Regulation Enhancement Through Exercise Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease, Arrhythmias
Keywords: Parasympathetic activity
Exercise
Education
Arrhythmias
Defibrillators, Implantable
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* 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

Primary outcomes:
measure: parasympathetic activity and regulation
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: arrhythmia frequency
timeFrame: 3 months, 6 months
measure: ICD therapy frequency
timeFrame: 3 months, 6 months
measure: exercise tolerance
timeFrame: 3 months, 6 months
measure: psychological well-being
timeFrame: 3 months, 6 months
measure: quality of life
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital Centers for Behavioral and Preventive Medicine
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Eva R Serber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer K, Tilkemeier PL, Buxton AE, Niaura R, Marcus B, Todaro J, Serber ER. Ratings of perceived exertion and physiological responses during exercise testing among ICD patients. Poster presented at the 32nd Annual Meeting of the Society for Behavioral Medicine, New Orleans, LA.; Abstract B-1621, Rapid Communications, April 2012.