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Exercise Activity Intervention for Atrial Fibrillation

This study is looking at whether a special exercise program, called the Physical Activity Intervention Using FitBit Wearable Device, can help improve symptoms of atrial fibrillation (AF), a condition where your heart beats irregularly. You might be able to join if you are at least 40 years old, have paroxysmal AF (AF that comes and goes), and have specific symptom scores and activity levels. The study aims to enroll 120 participants and will measure changes in your AF symptoms using the Atrial Fibrillation Severity Scale (AFSS) over 24 weeks. The current status of this study is unclear.

Study design
This is an interventional study with a sequential run-in control, planning to enroll 120 participants.
What's involved
You would participate in a 4-week control period, followed by a 24-week physical activity intervention period using a FitBit device.
Compensation
Not stated in the trial record.
Follow-up
Your AF symptoms will be measured at the end of the 24-week physical activity intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06938412

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

Recruiting
NAAges 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~120 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Physical Activity Intervention Using FitBit Wearable Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain
Measured over Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period

Conditions

Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases

Explore related trials

Atrial Fibrillation

NCT06938412

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Janice Y Chyou, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Joshua Wiener
[email protected]
646-761-3506
Email the study team

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Eligibility criteria

Inclusion

≥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

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.

What this trial measures

  • Atrial Fibrillation Severity Scale (AFSS), Symptom Severity DomainBaseline, 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.