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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845091
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : January 8, 2014
Information provided by (Responsible Party):
Eva R. Serber, The Miriam Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease, Arrhythmias Behavioral: Exercise Behavioral: Heart Healthy Education Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Autonomic Regulation Enhancement Through Exercise Trial
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
moderate-intensity, low-impact, supervised, aerobic exercise
Behavioral: Exercise
moderate-intensity, low-impact, supervised, aerobic exercise

Active Comparator: Heart Healthy Education
Educational topics on heart health (e.g., nutrition, smoking, sleep)
Behavioral: Heart Healthy Education
Educational topics related to heart health (e.g., nutrition, smoking, sleep)

Primary Outcome Measures :
  1. parasympathetic activity and regulation [ Time Frame: 3 months, 6 months ]

Secondary Outcome Measures :
  1. arrhythmia frequency [ Time Frame: 3 months, 6 months ]
  2. ICD therapy frequency [ Time Frame: 3 months, 6 months ]
  3. exercise tolerance [ Time Frame: 3 months, 6 months ]
  4. psychological well-being [ Time Frame: 3 months, 6 months ]
  5. quality of life [ Time Frame: 3 months, 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00845091

United States, Rhode Island
The Miriam Hospital Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Principal Investigator: Eva R Serber, Ph.D. The Miriam Hospital

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.

Responsible Party: Eva R. Serber, Assistant Professor (Research), The Miriam Hospital Identifier: NCT00845091     History of Changes
Other Study ID Numbers: HL092340
R21HL092340-01A1 ( U.S. NIH Grant/Contract )
RIH IRB, CMTT: 0177-08
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Keywords provided by Eva R. Serber, The Miriam Hospital:
Parasympathetic activity
Defibrillators, Implantable

Additional relevant MeSH terms:
Cardiovascular Diseases