Implementing Exercise After an (ICD)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/15/2018 |
| Start Date: | December 2018 |
| End Date: | December 2020 |
Translation of Exercise Interventions Into Practice After an ICD
This is the first feasibility test of a highly portable home-based exercise intervention
after an ICD, using technology monitoring (rather than self-report) of intervention progress
and outcomes. Evidence for intervention effectiveness will inform algorithms for initiating
exercise post-ICD more broadly in clinical practice. This study aligns directly with recent
scientific statements that recommend testing behavioral interventions for ICD patients that
are based on participant engagement, use cognitive behavioral approaches, and are readily
available when most needed.
after an ICD, using technology monitoring (rather than self-report) of intervention progress
and outcomes. Evidence for intervention effectiveness will inform algorithms for initiating
exercise post-ICD more broadly in clinical practice. This study aligns directly with recent
scientific statements that recommend testing behavioral interventions for ICD patients that
are based on participant engagement, use cognitive behavioral approaches, and are readily
available when most needed.
The goal of this study is to test an exercise intervention that we developed in previous RCTS
for feasibility in routine clinical practice. Based on results from our two completed
randomized trials of exercise after an ICD, the investigators created a home based exercise
program called (E-ICD) for use in routine practice that assists individuals to start and
monitor exercise safely after an ICD. The study uses a randomized, two group parallel
mixed-methods intervention trial, to determine the feasibility of the home-based E-ICD
exercise program in routine clinical care. Ninety patients in 3 study sites (30/site) will
participate in this 2 year study. The study sites are in the greater Seattle, WA area. This
intervention study is guided by the Reach-Efficacy-Adoption-Implementation-Maintenance
(RE-AIM) model. The E-ICD intervention consists of 12 weeks of home walking exercise after an
ICD using the E-ICD program, with an exercise prescription and protocols validated in our
previous work. The primary outcome of the study is total physical activity (steps/day) at 3
months. Measures will be taken at baseline, after the intervention at 3 months, and at 6
months. The specific aims of the study are to: 1) determine the reach, adoption and
implementation of E-ICD into the clinical setting, 2) compare intervention efficacy for
patient total daily activity (primary outcome) for E-ICD vs. usual care from baseline to
intervention completion at 3 months, and 3) describe exercise maintenance for patient
outcomes in E-ICD vs. usual care at 6 months.
for feasibility in routine clinical practice. Based on results from our two completed
randomized trials of exercise after an ICD, the investigators created a home based exercise
program called (E-ICD) for use in routine practice that assists individuals to start and
monitor exercise safely after an ICD. The study uses a randomized, two group parallel
mixed-methods intervention trial, to determine the feasibility of the home-based E-ICD
exercise program in routine clinical care. Ninety patients in 3 study sites (30/site) will
participate in this 2 year study. The study sites are in the greater Seattle, WA area. This
intervention study is guided by the Reach-Efficacy-Adoption-Implementation-Maintenance
(RE-AIM) model. The E-ICD intervention consists of 12 weeks of home walking exercise after an
ICD using the E-ICD program, with an exercise prescription and protocols validated in our
previous work. The primary outcome of the study is total physical activity (steps/day) at 3
months. Measures will be taken at baseline, after the intervention at 3 months, and at 6
months. The specific aims of the study are to: 1) determine the reach, adoption and
implementation of E-ICD into the clinical setting, 2) compare intervention efficacy for
patient total daily activity (primary outcome) for E-ICD vs. usual care from baseline to
intervention completion at 3 months, and 3) describe exercise maintenance for patient
outcomes in E-ICD vs. usual care at 6 months.
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.
We found this trial at
1
site
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Click here to add this to my saved trials
