Exercise for Atrial Fibrillation

(EASE-AF Trial)

Overseen By Kyle Reed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Heart failure, Severe liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a digital exercise program using a Fitbit can help individuals with atrial fibrillation (AF) feel better and experience fewer symptoms. AF causes the heart to beat irregularly, leading to palpitations or shortness of breath. Participants will use a Fitbit to monitor their physical activity, focusing on moderate to vigorous exercise. Those who experience intermittent AF symptoms and currently engage in 30 to 120 minutes of exercise weekly may be suitable for this trial. The goal is to develop a new, accessible exercise program for individuals with AF. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance exercise programs for AF patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise intervention using a FitBit wearable device is safe for patients with atrial fibrillation?

Research has shown that using a FitBit to track physical activity can help people with atrial fibrillation (AF) reach recommended exercise levels. This is linked to better heart health and a lower risk of AF. No reports indicate that the FitBit causes harm or is unsafe for people with AF. It counts steps and tracks activity, encouraging people to stay active. Studies have demonstrated that exercise is generally safe and beneficial for heart health. This method uses technology to help people with AF stay active without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a FitBit wearable device for atrial fibrillation (AF) because it offers a non-invasive and accessible way to manage the condition through physical activity. Unlike traditional treatments, such as medications or surgical interventions that focus on controlling heart rate or rhythm, this approach emphasizes lifestyle modification. The use of a FitBit allows for real-time monitoring and personalized exercise plans, empowering patients to take an active role in managing their health, which could lead to improved symptoms and quality of life.

What evidence suggests that this digital health-driven exercise intervention is effective for atrial fibrillation?

This trial will evaluate the use of a FitBit to track physical activity in patients with atrial fibrillation (AF). Studies have shown that a FitBit can help people with AF stay active, which is linked to better heart health and a lower risk of AF. Research indicates that individuals with AF tend to move less, but wearable devices can motivate them to reach exercise goals. This increase in physical activity is associated with fewer symptoms and a reduced impact of AF. Moreover, digital health tools like FitBits allow for better monitoring of heart health, leading to improved management of AF symptoms. Overall, using these devices to encourage exercise might be a promising way to help manage AF. ^{1 2 3 4 6}

Who Is on the Research Team?

Janice Y Chyou, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals who experience intermittent (paroxysmal) atrial fibrillation and have symptoms. It's designed to help those without easy access to exercise programs. Participants will be monitored using a FitBit device as part of the study.

Inclusion Criteria

I have been diagnosed with occasional irregular heartbeats.

Self-reports weekly moderate-vigorous physical activity (MVPA) 30-120 minutes

Electrocardiographic documentation of AF within 12 months (evidence required after initial post-ablation blanking period if prior AF ablation)

Exclusion Criteria

I have conditions like balance problems or nerve issues that limit my ability to exercise.

I am unable to understand and give consent for treatment.

Labile INR or unable to take anticoagulant despite indication

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Control

Participants undergo a 4-week run-in control period to establish baseline measurements

4 weeks

1 visit (in-person) at baseline

Physical Activity Intervention

Participants engage in a 24-week digital health-driven, patient-centered exercise intervention

24 weeks

Regular monitoring via wearable devices

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical Activity Intervention Using FitBit Wearable Device

Trial Overview The EASE-AF study tests whether a digital health-driven, personalized exercise program can improve symptoms and reduce the burden of atrial fibrillation in patients. The intervention uses FitBit wearable technology to track activity.

How Is the Trial Designed?

Group I: Patients With Atrial Fibrillation Experimental Treatment 1 Intervention

Patients with symptomatic, paroxysmal AF.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Regular physical activity, specifically 360-720 MET-minutes per week (about 60-120 minutes of moderate-to-vigorous exercise), is recommended for patients with atrial fibrillation (AF) to improve outcomes and quality of life, based on data from 21 studies.

Incorporating non-traditional exercises like Yoga into rehabilitation programs may enhance quality of life for AF patients, highlighting the need for personalized exercise plans in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Specific Exercise Rehabilitation: Are We There Yet? Buckley, BJR., Risom, SS., Boidin, M., et al.[2022]

Regular physical activity can significantly lower the risk of atrial fibrillation (AF), especially for individuals who exceed the current recommended exercise guidelines.

Achieving a cardiorespiratory fitness level of 8 METs or more during exercise testing is associated with a reduced incidence of AF, although excessive endurance exercise may paradoxically increase AF risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in atrial fibrillation prevention and promotion: Finding optimal ranges for health. Elliott, AD., Maatman, B., Emery, MS., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527120301156

Physical activity and atrial fibrillation: Data from wearable ... We provide the first evidence that AF is associated with a substantial, objectively measured reduction in physical activity, even after taking associated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8580729/

Physical Activity and Atrial Fibrillation: Data from Wearable ... Automatically collected step count data demonstrates that individuals with AF engage in significantly less average daily physical activity.

3. withpower.com withpower.com/trial/phase-atrial-fibrillation-3-2025-aa14f

Exercise for Atrial Fibrillation (EASE-AF Trial) Using a FitBit to track physical activity may help patients meet recommended exercise levels, which are associated with better heart health and reduced AF risk.

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033750

Wearable Devices, Health Care Use, and Psychological ... Wearables were associated with higher rates of symptom monitoring and preoccupation, AF treatment concerns, AF‐specific health care use, and use of informal ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2018.04.030

Mobile Health Advances in Physical Activity, Fitness, and ... In this review, the authors provide an update on cardiovascular mHealth by highlighting recent progress and challenges with mobile and wearable devices.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40379038/

Fitbit-measured physical activity is inversely associated with ... Fitbit-measured physical activity is inversely associated with incident atrial fibrillation among All of Us participants. Am Heart J. 2025 Nov:289:48-56.