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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva R. Serber, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00845091
First received: February 13, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Cardiovascular Disease, Arrhythmias
Behavioral: Exercise
Behavioral: Heart Healthy Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Autonomic Regulation Enhancement Through Exercise Trial

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • parasympathetic activity and regulation [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • arrhythmia frequency [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • ICD therapy frequency [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • exercise tolerance [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • psychological well-being [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845091

Locations
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
Investigators
Principal Investigator: Eva R Serber, Ph.D. The Miriam Hospital
  More Information

No publications provided

Responsible Party: Eva R. Serber, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00845091     History of Changes
Other Study ID Numbers: HL092340, R21 HL092340-01A1, RIH IRB, CMTT: 0177-08
Study First Received: February 13, 2009
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Parasympathetic activity
Exercise
Education
Arrhythmias
Defibrillators, Implantable

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014