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

NCT06938412 | Recruiting FDA Device

• 2 other identifiers: STUDY-24-0046424SCEFIA1249819
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain

  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.

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

Secondary Outcomes (5)

• Atrial Fibrillation Severity Scale (AFSS)

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

• AF Arrhythmia Burden: Percentage of time in AF

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

• AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode

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

• Weekly Step Counts

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

• Weekly Exercise Minutes

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

Study Arms (1)

Patients With Atrial Fibrillation

EXPERIMENTAL

Patients with symptomatic, paroxysmal AF.

Device: Physical Activity Intervention Using FitBit Wearable Device

Interventions

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.

Patients With Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• American Heart Association: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Janice Y Chyou, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Wiener

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)