Exercise Program for ICD Users

(E-ICD Trial)

Overseen By Cynthia M Dougherty, ARNP, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Washington

Disqualifiers: Serious mental disorder, Illicit drugs, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific exercise program benefits people with an implantable cardioverter defibrillator (ICD). The E-ICD intervention includes walking at moderate intensity for 30 minutes most days, using tools like a heart rate monitor and exercise logs, along with phone coaching. Individuals with an ICD who can walk independently for at least 5-10 minutes a day and have phone access for six months are suitable candidates. The trial compares this exercise program to usual care to assess its effectiveness in improving health outcomes. As a Phase 2, Phase 3 trial, it evaluates the program's effectiveness in a larger group and serves as a crucial step before potential FDA approval, offering participants a chance to contribute to significant advancements in ICD patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise intervention is safe for ICD users?

Research has shown that exercise programs for people with implantable cardioverter defibrillators (ICDs) are generally safe. Studies have found that these programs can improve fitness without causing harm. Most patients did not experience an increase in ICD shocks, which are quick electrical pulses that correct heart rhythm. Exercise programs like the E-ICD intervention use proven methods, such as home walking plans and regular check-ins, to ensure safety and effectiveness. Moderate exercise is not only safe for most people with ICDs but is also recommended to boost health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the E-ICD Intervention because it offers a structured, exercise-based approach tailored specifically for individuals with implantable cardioverter-defibrillators (ICDs). Unlike standard care, which typically involves routine follow-ups and general advice to maintain current activity levels, this intervention provides a comprehensive exercise program designed to improve cardiovascular health and patient engagement. Key features include personalized exercise prescriptions, home walking routines, and support from cardiac rehabilitation staff through telephonic coaching, making it a unique blend of technology and personalized care. This approach not only aims to enhance physical activity levels safely but also empowers ICD users to take an active role in their health management.

What evidence suggests that the E-ICD intervention is effective for ICD users?

Research shows that exercise programs for people with an implantable cardioverter defibrillator (ICD) can be very beneficial. In this trial, participants in the E-ICD Intervention arm will follow a structured exercise program for three months, including home walking and exercise monitoring tools. Studies indicate that after just three months of exercise, participants tend to be more active, taking more steps each day. Many also experience improvements in heart health, and the likelihood of the ICD delivering a shock remains low. Most studies report significant improvements in exercise performance, with ICD shocks being rare. Overall, the E-ICD program appears promising for increasing activity and ensuring safety for ICD users. ^{1 2 3 4 6}

Who Is on the Research Team?

Cynthia M Dougherty, ARNP, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had an ICD implanted to prevent sudden cardiac arrest. Participants must be able to walk unassisted for 5-10 minutes a day, speak and write English, and have access to a reliable phone for at least six months.

Inclusion Criteria

I can walk by myself for 5-10 minutes a day.

I am over 18 years old.

ICD implantation for primary or secondary prevention of sudden cardiac arrest

Exclusion Criteria

Current diagnosis of serious mental disorder

Regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.)

Concurrent participation in an exercise program > 5 days/week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the E-ICD intervention, a home-based exercise program, for 12 weeks

12 weeks

4 visits (telephone coaching)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcomes measured at 3, 6, and 12 months

9 months

3 visits (in-person or telephonic)

Maintenance

Participants receive an exercise prescription to maintain and increase exercise levels over the ensuing 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• E-ICD Intervention

Trial Overview The study is examining the effectiveness of an exercise program (E-ICD) designed specifically for individuals who have received an implantable cardioverter defibrillator (ICD).

How Is the Trial Designed?

Group I: E-ICD Intervention Experimental Treatment 1 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 II: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A four-week exercise rehabilitation program for myocardial infarction patients with moderate-to-severe left-ventricular dysfunction showed no deterioration in heart function, with some patients even experiencing slight improvements in ejection fraction (EF) during rest and exercise.

While some patients with a resting EF less than 30% developed complications, those with normal pulmonary wedge pressure (PWP) managed to complete the program without issues, suggesting that careful monitoring and individualized training can be safe and beneficial for patients with severe heart dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Special aspects of physical training during the rehabilitation stage of coronary patients]. Claus, J., Eisenriegler, E., Grodzinski, E., et al.[2007]

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

A goal-directed movement intervention using a movement sensor significantly increased the daily physical activity of hospitalized patients from an average of 38 minutes to 50 minutes, indicating its effectiveness in promoting movement during hospitalization.

Patients reported a decrease in perceived difficulty to move, suggesting that the intervention not only increased activity levels but also improved patients' confidence in their ability to move.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving physical activity in hospitalized patients: The preliminary effectiveness of a goal-directed movement intervention. van Grootel, J., Bor, P., Netjes, JA., et al.[2023]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11192781

Clinical Effectiveness of Exercise After an Implantable ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/300481/effectiveness-of-exercise-after-an-icd/

Effectiveness of Exercise After an ICD The primary effectiveness outcome is patient physical activity (steps/day) after the E-ICD intervention at 3 months. We will determine the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X16302110

Safety and Efficacy of Exercise Training in Patients With an ... Among patients with HF and ICD implantation, exercise training was associated with significant improvement in CRF and lower likelihood of ICD shocks.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6715540/

Exercise Interventions in Patients with Implantable ... Exercise performance measures were the most common primary endpoints (87.5%), with most studies (81%) demonstrating significant improvement. ICD shocks were ...

5. ahajournals.org ahajournals.org/doi/10.1161/circoutcomes.10.suppl_3.029

Abstract 029: Design, Safety and Effectiveness of Exercise ... Most studies (75%) showed statistically significant improvement in primary physiologic endpoints. ICD shocks were uncommon during active ...

6. escardio.org escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-17/lifestyle-advice-for-patients-with-icds-physical-activity-what-is-healthy-and-what-is-contraindicated

Lifestyle advice for patients with ICDs: physical activity Moderate leisure-time physical exercise is safe and clinically recommended for most individuals with ICDs [5]. The benefits of physical activity ...