Exercise for Atrial Fibrillation

(EASE-AF Trial)

Overseen By Joshua Wiener

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

Trial Summary

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 data supports the effectiveness of the treatment Physical Activity Intervention Using FitBit Wearable Device for atrial fibrillation?

Research suggests that engaging in regular moderate-intensity exercise can improve outcomes for people with atrial fibrillation, such as reducing the risk of recurrence and improving quality of life. 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. ^{1 2 3 4 5}

Is exercise safe for people with atrial fibrillation?

Engaging in moderate physical activity is generally encouraged for people with atrial fibrillation, and higher levels of physical activity are associated with a lower risk of developing atrial fibrillation. ^{1 6 7 8 9}

How does the Physical Activity Intervention Using FitBit differ from other treatments for atrial fibrillation?

The Physical Activity Intervention using a FitBit is unique because it uses a wearable device to encourage and monitor moderate-to-vigorous physical activity, which is not typically part of standard care for atrial fibrillation. This approach focuses on improving cardiovascular health and potentially reducing AF recurrence through personalized exercise, unlike traditional treatments that may focus more on medication or surgical interventions. ^{1 2 3 4 10}

What is the purpose of this trial?

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.

Research Team

Janice Y Chyou, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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 have had heart surgery or was hospitalized for heart failure within the last 3 months.

I am unable to understand and give consent for treatment.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with Moderate Physical Activity Among Older Adults with Atrial Fibrillation. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Atrial Fibrillation Specific Exercise Rehabilitation: Are We There Yet? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The role of exercise in atrial fibrillation prevention and promotion: Finding optimal ranges for health. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The Physical Activity Levels and Sitting Time of Adults Living With Atrial Fibrillation: The CHAMPLAIN-AF Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation versus usual care for patients treated with catheter ablation for atrial fibrillation: Results of the randomized CopenHeartRFA trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Postablation Atrial Fibrillation Burden and Patient Activity Level: Insights From the DISCERN AF Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Objectively Measured Physical Activity and the Risk of Atrial Fibrillation (from the REGARDS Study). [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Step Count, Self-reported Physical Activity, and Predicted 5-Year Risk of Atrial Fibrillation: Cross-sectional Analysis. [2023]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Exercise capacity and risk of incident atrial fibrillation in healthy adults. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Effects of a simple cardiac rehabilitation program on improvement of self-reported physical activity in atrial fibrillation - Data from the RACE 3 study. [2022]