Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03544489

Clinical Effectiveness of Exercise After an ICD (E-ICD)

Led by University of Washington · Updated on 2026-04-23

210

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a home-based exercise program called Exercise-ICD (E-ICD) for people who have an implantable cardioverter defibrillator (ICD). The study aims to test how effective this exercise intervention is and to understand how it can be implemented by cardiac rehabilitation staff. The study involves 210 participants across three local sites and uses a randomized two-group design comparing E-ICD to usual care, focusing on increasing physical activity and improving quality of life while reducing anxiety and depression related to ICD shocks. The E-ICD intervention consists of 12 weeks of home walking exercise designed to meet a goal of 30 minutes on most days at a moderate level. Participants receive exercise instructions through a DVD and manual, monitoring tools like a heart rate monitor and exercise logs, and telephone coaching from cardiac rehabilitation staff. After the 3-month intervention, participants are given a tailored exercise prescription to maintain or increase their activity over the next 3 months. The usual care group continues their standard follow-up and ICD monitoring without specific exercise guidance but is tracked for physical activity and healthcare use. Participants will be assessed at the start, after 3 months, and again at 6 and 12 months. Researchers will measure physical activity using daily step counts, health status, mobility, confidence in walking, anxiety related to ICD shocks, and depression. The study also monitors how well the exercise program is adopted and implemented by clinical staff, participant satisfaction, and adherence. The total study duration per participant is 12 months to evaluate both immediate and longer-term effects of the exercise program.

CONDITIONS

Brief Title

Effectiveness of Exercise After an ICD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 walk without assistive devices for at least 5 to 10 minutes per day
  • Age greater than 18 years
Not Eligible

You will not qualify if you...

  • Current diagnosis of a serious mental disorder
  • Regular non-medical use of illicit drugs such as opiates, cocaine, or amphetamines
  • Unstable angina, recent myocardial infarction, ICD shock, or heart surgery within the previous 3 months
  • Pregnancy
  • Currently participating in an exercise program more than 5 days per week

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants in the exercise group follow a home walking program for 12 weeks, including exercise instruction, monitoring tools, and telephone coaching by cardiac rehabilitation staff.

Weekly telephone coaching and home-based exercise sessions 4 or more times per week

Follow-up

Duration - Up to 12 months

Participants are monitored for maintenance of exercise and health outcomes with assessments at 3, 6, and 12 months after starting the program.

Assessments at 3, 6, and 12 months (in-person or telephone)

Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

C

Cynthia M Dougherty, ARNP, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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