Menu
Recruiting NCT06938412

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

No phase Interventional Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Activity Intervention Using FitBit Wearable Device.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Atrial Fibrillation Severity Scale (AFSS) [Time frame: 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 [Time frame: 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 [Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period]
  • Weekly Step Counts [Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period]
  • Weekly Exercise Minutes [Time frame: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT06938412 · STUDY-24-00464 · 24SCEFIA1249819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗