Home walking exercise for people with an ICD
Clinical Effectiveness of Exercise After an ICD (E-ICD)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT03544489 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.