Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Home walking exercise for people with an ICD

Official title: Clinical Effectiveness of Exercise After an ICD (E-ICD)

Run by University of Washington · NCT03544489 · Data updated 2026-11-12

This study will test a 12-week home walking program (E-ICD) to see if it increases daily steps for people with an implantable cardioverter defibrillator.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment210 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedMay 1, 2025
Main results expectedJune 30, 2029
Study endsJune 30, 2029
Registry record updatedApril 23, 2026
Trial IDNCT03544489 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with an implanted ICD who can ambulate without assistive devices, speak/read English, and have reliable phone access are ideal candidates.

Probably not a fit

Patients who are pregnant, have unstable angina/MI/ICD shock or heart surgery within the past 3 months, active serious mental illness or regular illicit drug use, or who already exercise more than five days per week are unlikely to receive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pragmatic effectiveness trial will enroll 210 adults with an ICD across three sites in the greater Seattle area and randomize them to the 12-week E-ICD home walking program or usual care. The intervention uses exercise prescriptions and remote monitoring components developed in prior RCTs and a pilot, and implementation is supported by cardiac rehabilitation staff using the RE-AIM framework. The primary outcome is physical activity measured as steps per day at 3 months, and mixed methods will describe implementation, reach, and adoption. The protocol follows the NIH stage III model to test effectiveness and real-world delivery.

Why it matters

Potential benefit: If successful, E-ICD could help people with ICDs safely increase daily activity and improve fitness and quality of life.

How similar studies have gone: The E-ICD protocol is adapted from prior randomized trials and a pilot by the same team that showed feasibility and informed the current effectiveness trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Washington
    Seattle, Washington, United States
    Recruiting

Study contacts

  • Principal investigator: Cynthia M Dougherty, ARNP, PhD — University of Washington
  • Study coordinator: Cynthia M Dougherty, ARNP, PhD
  • Email: cindyd@uw.edu
  • Phone: 206-221-7927

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.