Actively Recruiting
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-22
120
Participants Needed
1
Research Sites
N/A
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) is a common heart rhythm disorder affecting many people and often leads to symptoms that impact daily life. Researchers are investigating whether a digital, patient-centered exercise program using wearable technology can reduce AF symptoms and burden. This interventional study aims to establish evidence for a personalized exercise approach delivered through digital tools to improve care for patients with symptomatic, paroxysmal AF. The study involves a physical activity intervention using a FitBit wearable device to guide and track exercise with personalized goals. Participants will first complete a 4-week run-in control period, followed by a 24-week exercise intervention period using the FitBit device for sensor-based engagement. This approach tailors exercise plans and encourages progressive physical activity to manage AF symptoms. Participants will be evaluated at baseline, after the 4-week control period, and at the end of the 24-week intervention. Assessments include the Atrial Fibrillation Severity Scale focusing on symptom severity, AF arrhythmia burden measured by time and episode duration, as well as weekly step counts and exercise minutes. The study monitors exercise adherence and symptom changes over time to assess the impact of the digital exercise program. The total participation spans at least 28 weeks including both study periods.
CONDITIONS
Brief 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
- Diagnosis of paroxysmal atrial fibrillation
- Electrocardiographic or equivalent documentation 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 unable to take anticoagulants despite indication
- Life expectancy less than 1 year
- Receiving hemodialysis or having severe pulmonary or liver disease
- Musculoskeletal, balance, gait issues, severe peripheral vascular disease, neuropathy, or neurological conditions that limit exercise
- Self-reported weekly moderate to vigorous physical activity less than 30 minutes
- Baseline FitBit-measured weekly moderate to vigorous physical activity of 180 minutes or more at initial screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo a 4-week control period to establish baseline physical activity and symptom levels.
Baseline and end of 4-week run-in period visits
Duration - 24 weeks
Participants use a FitBit wearable device to engage in a tailored physical activity intervention with progressive goals for 24 weeks.
Visits at end of 24-week intervention period
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
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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