Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06938412
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Atrial Fibrillation Severity Scale (AFSS)', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': 'The full Atrial Fibrillation Severity Scale (AFSS) is composed of 19-items, investigating four domains: global well-being, symptom burden, health care utilization, symptom severity.\n\nGlobal well-being: 1-10; 10 denotes best possible quality of life. Symptom burden: Composite of AF burden as AF duration + AF frequency + AF severity; ranging 0-30, higher denotes more symptom burden.\n\nHealth care utilization: ER visits (0-7, higher number denotes more utilization), Hospitalizations (0-7, higher number denotes more utilization), Specialist visits (0-7, higher number denotes more utilization); Symptom Severity: 0-35, higher score denotes more severe AF-related symptoms'}, {'measure': 'AF Arrhythmia Burden: Percentage of time in AF', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': 'Global AF arrhythmia burden will be measured as percentage of time in AF measured during an 8-14-day monitoring period at the end of each time point as quantified by either clinically validated patch-based monitoring system or loop recorder.'}, {'measure': 'AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': 'Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder.'}, {'measure': 'Weekly Step Counts', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': 'Weekly step counts measured by FitBit wearable device provided by the study'}, {'measure': 'Weekly Exercise Minutes', 'timeFrame': 'Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period', 'description': 'Weekly exercise minutes measured by FitBit wearable device provided by the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Physical Activity', 'Exercise', 'Digital Health Intervention', 'Wearable Technology', 'Symptoms', 'Quality of Life'], 'conditions': ['Atrial Fibrillation', 'Arrhythmias, Cardiac', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥40years of age\n* Paroxysmal AF\n* 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)\n* AF Severity Scale (AFSS) symptom score 13-26\n* Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes\n\nExclusion Criteria:\n\n* Unable to give consent\n* ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization\n* 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\n* Labile INR or unable to take anticoagulant despite indication\n* Life expectancy \\< 1 year\n* Hemodialysis; severe pulmonary or liver disease\n* Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise\n* Self-report MVPA \\<30 minutes\n* 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."}, 'identificationModule': {'nctId': 'NCT06938412', 'acronym': 'EASE-AF', 'briefTitle': 'Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)', 'orgStudyIdInfo': {'id': 'STUDY-24-00464'}, 'secondaryIdInfos': [{'id': '24SCEFIA1249819', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients With Atrial Fibrillation', 'description': 'Patients with symptomatic, paroxysmal AF.', 'interventionNames': ['Device: Physical Activity Intervention Using FitBit Wearable Device']}], 'interventions': [{'name': 'Physical Activity Intervention Using FitBit Wearable Device', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Patients With Atrial Fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle Reed', 'role': 'CONTACT', 'email': 'kyle.reed@mssm.edu'}, {'name': 'Felix Che', 'role': 'CONTACT', 'email': 'felix.che@mountsinai.org'}, {'name': 'Janice Y Chyou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Joshua Wiener', 'role': 'CONTACT', 'email': 'EASE-AF@mountsinai.org', 'phone': '646-761-3506'}], 'overallOfficials': [{'name': 'Janice Y Chyou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning to share individual participant data. Aggregate data will be shared instead.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Janice.Chyou', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}