Exercise Program for ICD Users
(E-ICD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCynthia M Dougherty, ARNP, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.

Research Team

Cynthia M Dougherty, ARNP, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 18 who have had an ICD implanted to prevent sudden cardiac arrest. Participants must be able to walk unassisted for 5-10 minutes a day, speak and write English, and have access to a reliable phone for at least six months.

Inclusion Criteria

I can walk by myself for 5-10 minutes a day.

I am over 18 years old.

ICD implantation for primary or secondary prevention of sudden cardiac arrest

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Exclusion Criteria

Current diagnosis of serious mental disorder

Regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.)

Concurrent participation in an exercise program > 5 days/week

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Treatment Details

Interventions

E-ICD Intervention (Behavioral Intervention)

Trial OverviewThe study is examining the effectiveness of an exercise program (E-ICD) designed specifically for individuals who have received an implantable cardioverter defibrillator (ICD).

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: E-ICD InterventionExperimental Treatment1 Intervention

E-ICD Intervention over 3 months, consists of home walking to achieve the goal of 30 minutes on all or most of the days at moderate level intensity. E-ICD elements are: 1) exercise instructional DVD and manual, 2) exercise monitoring tools (Polar HR monitor, Borg scale, and exercise logs), and 3) telephone coaching by cardiac rehabilitation (CR) staff. Each participant receives an exercise prescription based on the ICD information using HR cut-offs, a minimum of 4 walking sessions/week will be prescribed. Exercise maintenance: At the 3 month conclusion of the E-ICD intervention, each patient will receive an exercise prescription based on the level they were able to achieve, with guidelines about increasing exercise to reach the target of 30 minutes/walking on all or most days over the ensuing 3 months.

Group II: Usual CareActive Control1 Intervention

Usual Care will receive treatment "as usual" from their health care clinicians with outcomes measured at baseline, 3, 6, and 12 months. Participants will not be discouraged from physical activity, but will be asked not to change their current level of activity for 6 months while in the study. Usual care involves ICD interrogation and follow-up every 3 months, measured either in-person or with home telephonic transmissions. Because participants in usual care may choose to participate in another exercise program, we will monitor those who participate in exercise programs and use the StepWatch monitor to quantify the amount and timing of physical activity. To control for group differences in attention, investigators will telephone usual care participants requesting information about health care utilization twice during the study at 3, 6, and 12 months.