RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-10
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06938412

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥40years of age
  2. * Paroxysmal AF
  3. * 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)
  4. * AF Severity Scale (AFSS) symptom score 13-26
  5. * Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes
  1. * Unable to give consent
  2. * ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
  3. * 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
  4. * Labile INR or unable to take anticoagulant despite indication
  5. * Life expectancy \< 1 year
  6. * Hemodialysis; severe pulmonary or liver disease
  7. * Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
  8. * Self-report MVPA \<30 minutes
  9. * 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.

Contacts and Locations

Study Contact

Joshua Wiener
CONTACT
646-761-3506
EASE-AF@mountsinai.org
Kyle Reed
CONTACT
kyle.reed@mssm.edu

Principal Investigator

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

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-10
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Atrial Fibrillation
  • Physical Activity
  • Exercise
  • Digital Health Intervention
  • Wearable Technology
  • Symptoms
  • Quality of Life

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Arrhythmias, Cardiac
  • Cardiovascular Diseases