Implementing Exercise After an (ICD)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03544489
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	N/A
Start date	July 1, 2019
Completion date	July 1, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Implementing Exercise After an (ICD) — E-ICD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms