Recruiting

Digital Exercise Intervention

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06938412

Conditions

Atrial Fibrillation

Arrhythmias, Cardiac

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical Activity Intervention Using FitBit Wearable Device

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Arrhythmias, Cardiac

Cardiovascular Diseases

Study ID

NCT06938412

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients With Atrial Fibrillation

Patients with symptomatic, paroxysmal AF.

Interventions

Physical 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Joshua Wiener

646-761-3506EASE-AF@mountsinai.org

Jaclyn Printz

Jaclyn.Printz@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Kyle Reed

kyle.reed@mssm.edu

Felix Che

felix.che@mountsinai.org

Principal Investigator:

Janice Y Chyou, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Atrial Fibrillation
  • Physical Activity
  • Exercise
  • Digital Health Intervention
  • Wearable Technology
  • Symptoms
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-24.