Heart ArrestE-ICDNCT03544489
Effectiveness of Exercise After an ICD
A study testing E-ICD Intervention in people with Heart Arrest and Implantable Defibrillator User, run by University of Washington at 1 site in United States.
Trial summary
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Implantable Defibrillator User, Physical Activity
- What is being tested?
- E-ICD Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Cynthia Dougherty, ARNP, PhD, 206-221-7927, cindyd@uw.edu
Cynthia Dougherty, ARNP, PhD
About this study
Official title: Clinical Effectiveness of Exercise After an ICD (E-ICD)
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.
Read the 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.
- Being tested
- E-ICD Intervention
- Medical subject headings
- Heart Arrest, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-ICD InterventionBehavioural
Home walking 3 days/week x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily activity
average steps/day measured on Step Watch activity monitor
Measured: Baseline, 3, 6, and 12 months
Secondary outcomes (5)
General Health
PROMIS Global v1.2 measures 5 domains of global health and quality of life, including physical, mental, and social health. Two factors physical health (GPH) and mental health (GMH) are derived.
Measured: Baseline, 3, 6, and 12 months
Mobility
PROMIS Mobility V2.1 measures general mobility of lower extremities in adults, relating to overall physical functioning
Measured: Baseline, 3, 6, and 12 months
Self-Efficacy for Walking
Self-Efficacy for Exercise Scale (9-items, α=0.92) assesses self-efficacy expectations related to one's ability to walk in the face of barriers to exercise [22], was used in the pilot and found to be sensitive to change with the intervention.
Measured: Baseline, 3, 6, and 12 months
ICD shock anxiety
Florida Shock Anxiety Scale (FSAS), assesses anxiety about receiving an ICD shock [23], is sensitive to change across time.
Measured: Baseline, 3, 6, and 12 months
Depression
Patient Health Questionnaire-9 (PHQ-9) (9 items, α=0.83), measures depressive symptoms, as well as suicidality.
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 May 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- home walking exercise
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia M. Dougherty, University of Washington
- Investigators
- Cynthia M Dougherty, ARNP, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544489
- Sponsor's protocol ID
- STUDY00020647
- Acronym
- E-ICD
- Status last verified
- Jul 2025
- First submitted
- 21 May 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Exercise After an ICD (E-ICD)
- ClinicalTrials.gov ID
- NCT03544489
- Acronym / sponsor ID
- E-ICD / STUDY00020647
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- home walking exercise
| Arm | Type | Receives |
|---|---|---|
| E-ICD Intervention | Experimental | Behavioral: E-ICD InterventionE-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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-ICD InterventionHome walking 3 days/week x 12 weeks | Behavioural | E-ICD Intervention |
Primary outcome
Daily activity
Time frame: Baseline, 3, 6, and 12 months
average steps/day measured on Step Watch activity monitor
5 secondary outcomes
General Health
Time frame: Baseline, 3, 6, and 12 months
Mobility
Time frame: Baseline, 3, 6, and 12 months
Self-Efficacy for Walking
Time frame: Baseline, 3, 6, and 12 months
ICD shock anxiety
Time frame: Baseline, 3, 6, and 12 months
Depression
Time frame: Baseline, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia M Dougherty, ARNP, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-ICD Intervention in people with Heart Arrest and Implantable Defibrillator User, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia M Dougherty, ARNP, PhD (206-221-7927, cindyd@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily activity (time frame: Baseline, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.