Implementing Exercise After an (ICD)

Study Overview
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Brief Summary
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This is the first feasibility test of a highly portable home-based exercise intervention after an ICD, using technology monitoring (rather than self-report) of intervention progress and outcomes. Evidence for intervention effectiveness will inform algorithms for initiating exercise post-ICD more broadly in clinical practice. This study aligns directly with recent scientific statements that recommend testing behavioral interventions for ICD patients that are based on participant engagement, use cognitive behavioral approaches, and are readily available when most needed.

Detailed Description
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The goal of this study is to test an exercise intervention that we developed in previous RCTS for feasibility in routine clinical practice. Based on results from our two completed randomized trials of exercise after an ICD, the investigators created a home based exercise program called (E-ICD) for use in routine practice that assists individuals to start and monitor exercise safely after an ICD. The study uses a randomized, two group parallel mixed-methods intervention trial, to determine the feasibility of the home-based E-ICD exercise program in routine clinical care. Ninety patients in 3 study sites (30/site) will participate in this 2 year study. The study sites are in the greater Seattle, WA area. This intervention study is guided by the Reach-Efficacy-Adoption-Implementation-Maintenance (RE-AIM) model. The E-ICD intervention consists of 12 weeks of home walking exercise after an ICD using the E-ICD program, with an exercise prescription and protocols validated in our previous work. The primary outcome of the study is total physical activity (steps/day) at 3 months. Measures will be taken at baseline, after the intervention at 3 months, and at 6 months. The specific aims of the study are to: 1) determine the reach, adoption and implementation of E-ICD into the clinical setting, 2) compare intervention efficacy for patient total daily activity (primary outcome) for E-ICD vs. usual care from baseline to intervention completion at 3 months, and 3) describe exercise maintenance for patient outcomes in E-ICD vs. usual care at 6 months.

Official Title
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Translation of Exercise Interventions Into Practice After an ICD

Conditions
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Heart Arrest, Implantable Defibrillator User, Physical Activity

Intervention / Treatment
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* Behavioral: E-ICD Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: home walking exercise
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-ICD Intervention<br>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, Digi-walker, Borg scale, and exercise logs), and 3) telephone coaching by clinic RNs. 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. Participants will record walking sessions each week in the exercise logs that will be collected again at 6 months. | Behavioral: E-ICD Intervention<br>* Home walking 3 days/week x 12 weeks<br>|
| No Intervention: Usual Care<br>Usual Care will receive treatment as usual from their health care clinicians with outcomes measured at baseline, 3 and 6 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 and 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily activity | average steps/day measured on Step Watch activity monitor | average of steps/day over 5 days after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health | Short Form Health Survey (SF-36) [Physical Composite Score (PCS)]. Scores range from 0-100 with higher scores representing higher functioning. The PCS score is created using weighted averages from the 8 subscales of the SF-36. | after 12 weeks | 
| General Health | Short Form Health Survey (SF-36) [Mental Composite Score (MCS)]. Scores range from 0-100 with higher scores representing higher functioning. The MCS score is created using weighted averages from the 8 subscales of the SF-36. | after 12 weeks |