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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured exercise program using wearable sensors (like a Fitbit) can reduce symptoms and improve outcomes in people with paroxysmal atrial fibrillation — a type of irregular heart rhythm that comes and goes. The program aims to help participants gradually increase their activity levels. **You may be eligible if...** - You are 40 years or older - You have paroxysmal (episodic) atrial fibrillation confirmed by an ECG or similar test within the past year - Your AF symptoms are in a moderate range on a symptom scale - You currently do 30–120 minutes of moderate-to-vigorous exercise per week **You may NOT be eligible if...** - You have had an AF ablation, heart procedure, or heart failure hospitalization in the last 90 days - Your heart pumping function is reduced, or you have significant valve disease or an implanted pacemaker/defibrillator - You have severe lung, liver, or kidney disease - You have musculoskeletal, neurological, or vascular conditions that limit exercise - Your actual measured exercise level is much higher than reported (over 180 min/week) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06938412


Related Trials