Atrial FibrillationEASE-AFNCT06938412
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
A study testing Physical Activity Intervention Using FitBit Wearable Device in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
- What is being tested?
- Physical Activity Intervention Using FitBit Wearable Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jaclyn Printz contact
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Kyle Reed, kyle.reed@mssm.edu
Felix Che, felix.che@mountsinai.org
About this study
Official title: Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
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.
- Being tested
- Physical Activity Intervention Using FitBit Wearable Device
- Keywords
- Atrial Fibrillation, Physical Activity, Exercise, Digital Health Intervention, Wearable Technology, Symptoms, Quality of Life
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Intervention Using FitBit Wearable DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Atrial Fibrillation | Experimental | Patients with symptomatic, paroxysmal AF. Receives: Device: Physical Activity Intervention Using FitBit Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain
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.
Measured: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Secondary outcomes (5)
Atrial Fibrillation Severity Scale (AFSS)
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.
Global 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.
Health 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
Measured: 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
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.
Measured: 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
Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder.
Measured: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Weekly Step Counts
Weekly step counts measured by FitBit wearable device provided by the study
Measured: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Weekly Exercise Minutes
Weekly exercise minutes measured by FitBit wearable device provided by the study
Measured: Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start11 Aug 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Janice.Chyou, Icahn School of Medicine at Mount Sinai
- Investigators
- Janice Y Chyou, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938412
- Sponsor's protocol ID
- STUDY-24-00464
- Other IDs
- 24SCEFIA1249819
- Acronym
- EASE-AF
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not planning to share individual participant data. Aggregate data will be shared instead.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
- ClinicalTrials.gov ID
- NCT06938412
- Acronym / sponsor ID
- EASE-AF / STUDY-24-00464
- Keywords
- Atrial Fibrillation, Physical Activity, Exercise, Digital Health Intervention, Wearable Technology, Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Atrial Fibrillation | Experimental | Device: Physical Activity Intervention Using FitBit Wearable DevicePatients with symptomatic, paroxysmal AF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Intervention Using FitBit Wearable DeviceThe 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. | Device | Patients With Atrial Fibrillation |
Primary outcome
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
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. Not planning to share individual participant data. Aggregate data will be shared instead.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaclyn Printz contact
Janice Y Chyou, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Intervention Using FitBit Wearable Device in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Wiener (646-761-3506, EASE-AF@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.