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

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

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 Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: Physical Activity Intervention Using FitBit Wearable Device

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Wiener; Phone Number: 646-761-3506; Email: EASE-AF@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Janice Y Chyou, MD
      • Contact: Kyle Reed; Email: Kyle.Reed@mssm.edu
      • Contact: Felix Che; Email: felix.che@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients With Atrial Fibrillation; Patients with symptomatic, paroxysmal AF.	Device: Physical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation Severity Scale (AFSS)	The full Atrial Fibrillation Severity Scale (AFSS) is composed of 19-items, investigating four domains: global well-being, symptom burden, health care utilization, symptom severity. Global well-being: 1-10; 10 denotes best possible quality of life. Symptom burden: Composite of AF burden as AF duration + AF frequency + AF severity; ranging 0-30, higher denotes more symptom burden. Health care utilization: ER visits (0-7, higher number denotes more utilization), Hospitalizations (0-7, higher number denotes more utilization), Specialist visits (0-7, higher number denotes more utilization); Symptom Severity: 0-35, higher score denotes more severe AF-related symptoms	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
AF Arrhythmia Burden: Percentage of time in AF	Global AF arrhythmia burden will be measured as percentage of time in AF measured during an 8-14-day monitoring period at the end of each time point as quantified by either clinically validated patch-based monitoring system or loop recorder.	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode	Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder.	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Weekly Step Counts	Weekly step counts measured by FitBit wearable device provided by the study	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Weekly Exercise Minutes	Weekly exercise minutes measured by FitBit wearable device provided by the study	Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Janice Y Chyou, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Atrial Fibrillation; Quality of Life; Digital Health Intervention; Symptoms; Wearable Technology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Motor Activity
• Other Study ID Numbers: STUDY-24-00464; 24SCEFIA1249819 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planning to share individual participant data. Aggregate data will be shared instead.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No