Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥40years of age
Paroxysmal AF
Electrocardiographic (or equivalent) documentation of AF within 12 months (would need to have evidence of AF after initial post-ablation blanking period if the patient had prior AF ablation)
AF Severity Scale (AFSS) symptom score 13-26
Disqualifiers
Unable to give consent
≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
Left ventricular ejection fraction (LVEF) <50%, moderate to severe stenotic valvular heart disease or severe regurgitant valvular disease or history of mechanical valve replacement, presence of implanted pacemaker or defibrillator system
Labile INR or unable to take anticoagulant despite indication
Trial design
Design model
Single group
Treatments tested in this trial
Physical Activity Intervention Using FitBit Wearable Device
DeviceThe intervention is a digital technology-driven, patient-centric approach to physical activity and exercise intervention with tailored digital engagement and progressive physical activity goals (the intervention). The intervention will be conducted using FitBit wearable device.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Patients With Atrial FibrillationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain
The Symptom Severity domain (Part C) of the validated Atrial Fibrillation Severity Scale (AFSS) questions patients regarding the severity of 7 AF-related symptoms (on scale of 0-5 per question, 5 denoting a great deal of symptom and 0 with no symptom) over the preceding 4-week period. Total scores range 0-35 on the Symptom Severity Domain of the Atrial Fibrillation Severity Scale (AFSS), higher score denotes more severe AF-related symptoms.
Time frame
Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention PeriodSecondary outcomes
1
Atrial Fibrillation Severity Scale (AFSS)
The full Atrial Fibrillation Severity Scale (AFSS) is composed of 19-items, investigating four domains: global well-being, symptom burden, health care utilization, symptom severity. Global well-being: 1-10; 10 denotes best possible quality of life. Symptom burden: Composite of AF burden as AF duration + AF frequency + AF severity; ranging 0-30, higher denotes more symptom burden. Health care utilization: ER visits (0-7, higher number denotes more utilization), Hospitalizations (0-7, higher number denotes more utilization), Specialist visits (0-7, higher number denotes more utilization); Symptom Severity: 0-35, higher score denotes more severe AF-related symptoms
Time frame
Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period2
AF Arrhythmia Burden: Percentage of time in AF
Global AF arrhythmia burden will be measured as percentage of time in AF measured during an 8-14-day monitoring period at the end of each time point as quantified by either clinically validated patch-based monitoring system or loop recorder.
Time frame
Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period3
AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode
Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder.
Time frame
Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period4
Weekly Step Counts
Weekly step counts measured by FitBit wearable device provided by the study
Time frame
Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention PeriodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov