Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
Sponsor: Icahn School of Medicine at Mount Sinai
Trial Details
| Condition | Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases |
| Intervention | Physical Activity Intervention Using FitBit Wearable Device |
| Phase | NA |
| Status | Recruiting |
| Participants | 120 |
| Est. Completion | 31 Mar 2027 |
| Last Updated | 22 May 2026 |
Primary Outcome
Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service