Effectiveness of Exercise After an ICD

NCT03544489 | Recruiting

• 1 other identifier: STUDY00020647
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Arrest; Implantable Defibrillator User; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Daily activity

  average steps/day measured on Step Watch activity monitor

  Baseline, 3, 6, and 12 months

Secondary Outcomes (5)

• General Health

  Baseline, 3, 6, and 12 months

• Mobility

  Baseline, 3, 6, and 12 months

• Self-Efficacy for Walking

  Baseline, 3, 6, and 12 months

• ICD shock anxiety

  Baseline, 3, 6, and 12 months

• Depression

  Baseline, 3, 6, and 12 months

Other Outcomes (1)

• Long Term Maintenance

  12 months

Study Arms (2)

E-ICD Intervention

EXPERIMENTAL

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.

Behavioral: E-ICD Intervention

Usual Care

NO 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.

Interventions

E-ICD Intervention BEHAVIORAL

Home walking 3 days/week x 12 weeks

E-ICD Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Cynthia M Dougherty, ARNP, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia M Dougherty, ARNP, PhD

CONTACT

206-221-7927; cindyd@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: home walking exercise

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)