Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Recruiting · NCT06938412 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- ≥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
- Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes
Exclusion criteria
- 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
- Life expectancy \< 1 year
- Hemodialysis; severe pulmonary or liver disease
- Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
- Self-report MVPA \<30 minutes
- Upon initial screening, if the participant's baseline FitBit-measured MVPA ≥180 minutes/week (despite self-report range of 30-120 minutes), the participant will be further excluded.
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States