Sensor-guided exercise program for people with atrial fibrillation
Official title: Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
Run by Icahn School of Medicine at Mount Sinai · NCT06938412 · Data updated 2026-11-12
This program will test whether a Fitbit-based, personalized exercise plan can reduce symptoms and episode burden in people with paroxysmal atrial fibrillation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 11, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT06938412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 or older with documented paroxysmal AF, an AF Symptom Scale score of 13–26, and self-reported weekly moderate-to-vigorous activity of 30–120 minutes.
✕Probably not a fit
Patients with persistent AF, significantly reduced LVEF (<50%), implanted pacemakers/defibrillators, recent major cardiac procedures, severe comorbidities, or major mobility limitations are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
EASE-AF is a prospective, interventional study using a sequential run-in control to deliver a wearable-driven, patient-centered exercise intervention. The team will enroll 120 adults with symptomatic paroxysmal AF who meet specific symptom and activity criteria and use a Fitbit to monitor and engage participants. The intervention tailors moderate-to-vigorous physical activity goals and uses sensor feedback and digital support to encourage adherence. Outcomes focus on changes in AF symptoms and arrhythmia burden compared with the run-in period.
Why it matters
Potential benefit: If successful, this approach could reduce AF symptoms and episode burden while making tailored exercise programs more accessible through wearables.
How similar studies have gone: Prior exercise programs have shown improvements in AF symptoms and burden, while wearable-guided, digital exercise interventions are promising but remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Janice Y Chyou, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Joshua Wiener
- Email: EASE-AF@mountsinai.org
- Phone: 646-761-3506
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.