Actively Recruiting
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-10-03
120
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years of age or older
- Diagnosed with paroxysmal atrial fibrillation
- Electrocardiographic (or equivalent) evidence of AF within the past 12 months
- AF Severity Scale symptom score between 13 and 26
- Self-reported weekly moderate to vigorous physical activity between 30 and 120 minutes
You will not qualify if you...
- Unable to give consent
- Less than 90 days since AF ablation, coronary revascularization, or heart failure hospitalization
- Left ventricular ejection fraction below 50%, moderate to severe stenotic valvular heart disease, severe regurgitant valvular disease, history of mechanical valve replacement, or presence of implanted pacemaker or defibrillator
- Labile INR or inability to take anticoagulants despite indication
- Life expectancy under 1 year
- Receiving hemodialysis or having severe pulmonary or liver disease
- Musculoskeletal, balance or gait problems, severe peripheral vascular disease, neuropathy, or other neurological conditions limiting exercise
- Self-reported moderate to vigorous physical activity under 30 minutes per week
- Baseline FitBit-measured moderate to vigorous physical activity 180 minutes or more per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Joshua Wiener
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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