Clinical trial NCT06938412: Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Official title: Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Keywords: Atrial Fibrillation
Physical Activity
Exercise
Digital Health Intervention
Wearable Technology
Symptoms
Quality of Life
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2025-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Secondary outcomes:
measure: Atrial Fibrillation Severity Scale (AFSS)
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
measure: AF Arrhythmia Burden: Percentage of time in AF
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
measure: AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
measure: Weekly Step Counts
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
measure: Weekly Exercise Minutes
timeFrame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Janice Y Chyou, MD
role: PRINCIPAL_INVESTIGATOR
References: