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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06938412
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients With Atrial Fibrillation
    Patients with symptomatic, paroxysmal AF.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Felix Che
[email protected]
Janice Y Chyou, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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