This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin remote patient monitoring network. Patients will be randomized in a 1:1 fashion to usual care plus a remotely administered home based weekly prescription for aerobic exercise (intervention) or usual care alone (control). Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, implantable device measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
13
Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist. The exercise prescription will change each week based on refreshed data from the prior week. Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR.
Duke University Medical Center
Durham, North Carolina, United States
Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA)
Reported in minutes of PA per day.
Time frame: 12 weeks after randomization
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score
The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.
Time frame: Baseline to 12 weeks
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
Time frame: Cumulative during 12 weeks of intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score
The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.
Time frame: 12 weeks after randomization
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