Implementing Exercise After an (ICD)

Physical Activity Clinical Trial

— E-ICD  

Official title:

Translation of Exercise Interventions Into Practice After an ICD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544489
• Other study ID #: STUDY00002057
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Implantable Defibrillator User
• Physical Activity

Intervention

Behavioral:
• E-ICD Intervention
Home walking 3 days/week x 12 weeks

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily activity	average steps/day measured on Step Watch activity monitor	average of steps/day over 5 days after 12 weeks
Secondary	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
Secondary	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