Clinical Effectiveness of Exercise After an ICD (E-ICD)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Cynthia M Dougherty, ARNP, PhD
cindyd@uw.edu
206-221-7927
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2029-09-14
Participants
Target number of participants: 210
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Washington