RecruitingNot ApplicableNCT06938412

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

120 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac

Summary

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

Min Age: 18 Years

Inclusion Criteria5

≥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 Criteria9

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.

Interventions

DEVICEPhysical Activity Intervention Using FitBit Wearable Device

The 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.