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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the E-ICD Intervention treatment for ICD users?

Research shows that patient education and home exercise programs can help people with chronic illnesses become more active. This suggests that similar approaches, like the E-ICD Intervention, might also help ICD users improve their physical activity. ^{1 2 3 4 5}

Is exercise generally safe for people with ICDs?

Exercise programs, including those for people with chronic conditions, are generally safe with few serious adverse events reported. Most issues are minor, like muscle injuries, and can be minimized by starting slowly and gradually increasing intensity. ^{6 7 8 9 10}

How does the E-ICD Intervention treatment differ from other treatments for ICD users?

The E-ICD Intervention is unique because it focuses on a structured exercise program specifically designed for people with implantable cardioverter defibrillators (ICDs), helping them safely engage in physical activity without fear of triggering a device shock. This approach is different from standard treatments, which may not emphasize exercise as a key component of managing ICD-related concerns. ^{11 12 13 14 15}

Research Team

Cynthia M Dougherty, ARNP, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Meta-analysis of patient education interventions to increase physical activity among chronically ill adults. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Attitudes and expectations regarding exercise in the hospital of hospitalized older adults: a qualitative study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effects of a nurse-supervised home exercise programme on improving patients' perceptions of the benefits and barriers to exercise: A randomised controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

How much do hospitalized adults move? A systematic review and meta-analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Improving physical activity in hospitalized patients: The preliminary effectiveness of a goal-directed movement intervention. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Does home-based exercise improve body mass index in patients with type 2 diabetes? Results of a feasibility trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Increased confidence to engage in physical exertion: older ICD recipients' experiences of participating in an exercise training programme. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Prescribing exercise training for patients with defibrillators. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Special aspects of physical training during the rehabilitation stage of coronary patients]. [2007]

14. United States pubmed.ncbi.nlm.nih.gov

Exercise Is Medicine Initiative: Physical Activity as a Vital Sign and Prescription in Adult Rehabilitation Practice. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Exercise on Prescription: A Cross-sectional Study With Self-reported Outcome. [2019]