# Clinical Effectiveness of Exercise After an Implantable Cardioverter Defibrillator (ICD)

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $728,781

## Abstract

Abstract
The goal of this study is to test the effectiveness and describe implementation of a home based exercise
intervention for persons with an implantable cardioverter defibrillator (ICD). This study is based on the NIH
stage model of behavioral interventions (stage III effectiveness) that aligns with the strategic mission of the
NHLBI, to optimize clinical and implementation research to improve health and reduce disease (Obj #6). The
study intervention is based on the protocol and monitoring components that were developed in prior RCTs and
a pilot study conducted by our team. From these studies, we created a home based exercise program called
Exercise-ICD (E-ICD) for testing in a broader range of ICD patients, that assists individuals to start and monitor
exercise safely after an ICD. An randomized two group (E-ICD vs. usual care) pragmatic effectiveness mixed-
methods study is proposed, to determine the effectiveness of the E-ICD intervention and describe
implementation by cardiac rehabilitation (CR) clinical staff. Two hundred ten (N=210) patients in 3 local study
sites (70/site) in the greater Seattle, WA area will participate. E-ICD is guided by the Reach-Effectiveness-
Adoption-Implementation-Maintenance (RE-AIM) model. The E-ICD intervention consists of 12 weeks of home
walking exercise using exercise prescriptions and protocols validated in our previous work. The primary
effectiveness outcome is patient physical activity (steps/day) after the E-ICD intervention at 3 months. We will
determine the number of patients who reach the public health walking goal of moderate level exercise of 150
minutes/week at the end of the study. Measures will be taken at baseline, after the intervention at 3 months,
and at 6 and 12 months to determine maintenance. The specific aims are to: 1) Test the hypothesis that
participants randomized to E-ICD vs. usual care (UC) will demonstrate increased physical activity (minutes
walked/week) [primary outcome], health related quality of life, gait speed, mobility, exercise self-efficacy; and
reduced ICD shock anxiety and depression at 3 months (E-ICD Effectiveness), 2) Assess longer term effects of
E-ICD on participant and health care system Maintenance, captured by 1) participant retention, satisfaction,
and adherence at 12 months (total minutes/week), and 2) clinician and institutional intent to sustain use of the
E-ICD intervention after the study, and 3) Evaluate the reach, adoption, and implementation of E-ICD by CR
clinical staff. Reach will be assessed by the diverse patient participation rate, representativeness, and reasons
for non-interest. Adoption is the participation rate and representativeness of the settings and staff who
participate, and factors related to adoption. Implementation will be assessed by delivery fidelity of E-ICD and
workflow adaptations, implementation costs, and consistency of delivery across settings. Intervention
effectiveness will be described by participant social determinants ...

## Key facts

- **NIH application ID:** 10941357
- **Project number:** 1R01HL174673-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** CYNTHIA M DOUGHERTY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $728,781
- **Award type:** 1
- **Project period:** 2024-09-15 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10941357

## Citation

> US National Institutes of Health, RePORTER application 10941357, Clinical Effectiveness of Exercise After an Implantable Cardioverter Defibrillator (ICD) (1R01HL174673-01). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10941357. Licensed CC0.

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