Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
NCT ID: NCT06938412
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-10-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients With Atrial Fibrillation
Patients with symptomatic, paroxysmal AF.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* ≤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.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Janice.Chyou
Assistant Clinical Professor
Principal Investigators
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Janice Y Chyou, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24SCEFIA1249819
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY-24-00464
Identifier Type: -
Identifier Source: org_study_id
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