Recruiting

E-ICD

Sponsor:

University of Washington

Code:

NCT03544489

Conditions

Heart Arrest

Implantable Defibrillator User

Physical Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E-ICD Intervention

Study Details

Brief summary:

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

Conditions

Heart Arrest

Implantable Defibrillator User

Physical Activity

Study ID

NCT03544489

Start date

May 1, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ICD implantation for primary or secondary prevention of sudden cardiac arrest, -ability to read, speak and write English,-
  • access to a reliable phone for 6 months after study entry,
  • able to ambulate without assist devices for at least 5-10 minutes/day
  • greater than 18 years of age.

Exclusion Criteria:

  • current diagnosis of serious mental disorder,
  • regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.), -unstable angina, myocardial infarction, ICD shock or heart surgery within previous 3 months
  • pregnancy
  • concurrent participation in an exercise program > 5 days/week.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: E-ICD 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.

no intervention: Usual Care

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.

Interventions

E-ICD Intervention

Home walking 3 days/week x 12 weeks

Primary outcome measure

  • Daily activity [ Time Frame: Baseline, 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Cynthia M Dougherty, ARNP, PhD

206-221-7927cindyd@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Cynthia Dougherty, ARNP, PhD

206-221-7927cindyd@uw.edu

Principal Investigator:

Cynthia Dougherty, ARNP, PhD

More Information

Sponsor

University of Washington

Last update posted

Apr 23, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-04-23.