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Completed

NCT Number: NCT00845091

Cardiac Autonomic Regulation Enhancement Through Exercise Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Miriam Hospital Centers for Behavioral and Preventive Medicine

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Heart Healthy Education

Behavioral

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

Primary outcomes

  1. parasympathetic activity and regulation

    Time frame: 3 months, 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Acronym: CARE-E

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 16, 2009
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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