Cardiac Autonomic Regulation Enhancement Through Exercise Trial

NCT ID: NCT00845091

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-07-31

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.

Conditions

Cardiovascular Disease, Arrhythmias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

moderate-intensity, low-impact, supervised, aerobic exercise

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

moderate-intensity, low-impact, supervised, aerobic exercise

Heart Healthy Education

Educational topics on heart health (e.g., nutrition, smoking, sleep)

Group Type: ACTIVE_COMPARATOR

Heart Healthy Education

Intervention Type: BEHAVIORAL

Educational topics related to heart health (e.g., nutrition, smoking, sleep)

Interventions

Exercise

moderate-intensity, low-impact, supervised, aerobic exercise

Intervention Type: BEHAVIORAL

Heart Healthy Education

Educational topics related to heart health (e.g., nutrition, smoking, sleep)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eva R. Serber

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva R Serber, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

The Miriam Hospital Centers for Behavioral and Preventive Medicine

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

R21HL092340-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RIH IRB, CMTT: 0177-08

Identifier Type: -

Identifier Source: secondary_id

HL092340

Identifier Type: -

Identifier Source: org_study_id