Effectiveness of Exercise After an ICD

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT03544489
Status
Recruiting
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Conditions

  • Heart Arrest
  • Implantable Defibrillator User
  • Physical Activity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • E-ICD Intervention — BEHAVIORAL
    Home walking 3 days/week x 12 weeks

Study Details

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

Key Dates

Start date
May 1, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Cynthia Dougherty, ARNP, PhD
[email protected]
206-221-7927
Cynthia Dougherty, ARNP, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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