Effectiveness of Exercise After an ICD

NCT ID: NCT03544489

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2029-09-14

Brief Summary

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

Detailed Description

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.

Conditions

Heart Arrest; Implantable Defibrillator User; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

E-ICD Intervention

Intervention Type: BEHAVIORAL

Home walking 3 days/week x 12 weeks

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

E-ICD Intervention

Home walking 3 days/week x 12 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia M. Dougherty

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia M Dougherty, ARNP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cynthia M Dougherty, ARNP, PhD

Role: CONTACT

cindyd@uw.edu

206-221-7927

Facility Contacts

Cynthia Dougherty, ARNP, PhD

Role: primary

cindyd@uw.edu

206-221-7927

Other Identifiers

STUDY00020647

Identifier Type: -

Identifier Source: org_study_id