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NCT Number: NCT06938412

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Felix Che

CONTACT

[email protected]

Janice Y Chyou, MD

PRINCIPAL_INVESTIGATOR

Kyle Reed

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥40years of age
  • Paroxysmal AF
  • Electrocardiographic (or equivalent) documentation of AF within 12 months (would need to have evidence of AF after initial post-ablation blanking period if the patient had prior AF ablation)
  • AF Severity Scale (AFSS) symptom score 13-26
  • Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes

Exclusion criteria

  • Unable to give consent
  • ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
  • Left ventricular ejection fraction (LVEF) <50%, moderate to severe stenotic valvular heart disease or severe regurgitant valvular disease or history of mechanical valve replacement, presence of implanted pacemaker or defibrillator system
  • Labile INR or unable to take anticoagulant despite indication
  • Life expectancy < 1 year
  • Hemodialysis; severe pulmonary or liver disease
  • Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
  • Self-report MVPA <30 minutes
  • Upon initial screening, if the participant's baseline FitBit-measured MVPA ≥180 minutes/week (despite self-report range of 30-120 minutes), the participant will be further excluded.

Treatment and study plan

Physical Activity Intervention Using FitBit Wearable Device

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.

Primary outcomes

  1. Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    The Symptom Severity domain (Part C) of the validated Atrial Fibrillation Severity Scale (AFSS) questions patients regarding the severity of 7 AF-related symptoms (on scale of 0-5 per question, 5 denoting a great deal of symptom and 0 with no symptom) over the preceding 4-week period. Total scores range 0-35 on the Symptom Severity Domain of the Atrial Fibrillation Severity Scale (AFSS), higher score denotes more severe AF-related symptoms.

Secondary outcomes

  1. Atrial Fibrillation Severity Scale (AFSS)

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    The full Atrial Fibrillation Severity Scale (AFSS) is composed of 19-items, investigating four domains: global well-being, symptom burden, health care utilization, symptom severity.

    Global well-being: 1-10; 10 denotes best possible quality of life. Symptom burden: Composite of AF burden as AF duration + AF frequency + AF severity; ranging 0-30, higher denotes more symptom burden.

    Health care utilization: ER visits (0-7, higher number denotes more utilization), Hospitalizations (0-7, higher number denotes more utilization), Specialist visits (0-7, higher number denotes more utilization); Symptom Severity: 0-35, higher score denotes more severe AF-related symptoms

  2. AF Arrhythmia Burden: Percentage of time in AF

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    Global AF arrhythmia burden will be measured as percentage of time in AF measured during an 8-14-day monitoring period at the end of each time point as quantified by either clinically validated patch-based monitoring system or loop recorder.

  3. AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder.

  4. Weekly Step Counts

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    Weekly step counts measured by FitBit wearable device provided by the study

  5. Weekly Exercise Minutes

    Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

    Weekly exercise minutes measured by FitBit wearable device provided by the study

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Wiener

CONTACT

[email protected]

646-761-3506

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)

Acronym: EASE-AF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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