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

Icahn School of Medicine at Mount Sinai120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.