What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include antiarrhythmic drugs and exercise-based cardiac rehabilitation. Antiarrhythmic drugs like dronedarone can increase the risk of cardiovascular events such as stroke, myocardial infarction, and heart failure, and require regular monitoring for potential liver and lung issues. Exercise-based cardiac rehabilitation, which improves cardiovascular health through structured physical activity, generally has fewer side effects but may cause muscle soreness, fatigue, or exacerbate underlying conditions if not properly supervised.

What prior FDA approvals exist?

Several antiarrhythmic drugs have received FDA approval for the treatment of Atrial Fibrillation (AF), including ibutilide, flecainide, propafenone, and amiodarone. These medications are used to restore normal heart rhythm and manage symptoms. In addition to pharmacologic treatments, exercise-based cardiac rehabilitation has shown promise in improving cardiovascular health, enhancing heart function, and reducing inflammation in patients with AF. This approach involves structured physical activity and has been studied for its potential benefits in reducing AF recurrence and improving overall heart health.

What other types of research exist?

Promising novel alternatives to exercise-based cardiac rehabilitation for atrial fibrillation patients include: 1) Catheter ablation techniques with improved precision and safety profiles, 2) Advanced pharmacological treatments targeting specific pathways involved in AF, such as anti-inflammatory and anti-fibrotic agents, 3) Wearable technology for continuous monitoring and early detection of AF episodes, and 4) Personalized medicine approaches using genetic and biomarker profiling to tailor treatments to individual patient needs.

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Cardiac Rehabilitation for Atrial Fibrillation

N/A

Waitlist Available

Research Sponsored by MultiCare Health System Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of Paroxysmal and persistent Atrial Fibrillation

Be older than 18 years old

Must not have

Does not speak English

Documented cardiovascular disease or pulmonary/respiratory disease that would qualify the patient for Cardiac, Pulmonary or Vascular Rehabilitation at a Pulse Heart Institute rehabilitation program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after the first intake appointment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an exercise program to see if it can help prevent a heart condition from coming back in patients who have had a specific treatment. The program aims to make the heart stronger and healthier through regular exercise. Researchers will check the patients periodically to see if the exercise helped.

Who is the study for?

This trial is for adults over 18 with Paroxysmal and persistent Atrial Fibrillation who've had an ablation procedure at least 2 weeks ago. Participants must be able to attend a cardiac rehab program thrice weekly for 12 weeks, follow medication therapy, and have no physical limitations or severe cognitive impairments that prevent exercise.

What is being tested?

The study tests if a supervised 12-week exercise-based cardiac rehabilitation program can reduce the recurrence of atrial fibrillation after an ablation procedure. Patients are randomly assigned to either this intervention group or a control group receiving usual care.

What are the potential side effects?

While not explicitly listed, potential side effects may include typical risks associated with exercise such as muscle strains, fatigue, shortness of breath during activity, and in rare cases, heart-related events especially given the patient population's underlying condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Atrial Fibrillation that comes and goes or stays.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I have heart or lung disease that qualifies me for a rehabilitation program.

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I have been diagnosed with dementia or have cognitive issues.

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I cannot do rehab exercises because of my physical condition.

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I have had more than one ablation procedure.

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I have had atrial fibrillation for a long time.

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I have had a procedure to isolate the posterior wall of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after the first intake appointment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after the first intake appointment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after the first intake appointment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in 40 patients at six- and twelve-months post-ablation procedure.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: cardiac rehabilitation intervention groupExperimental Treatment1 Intervention

Participants assigned to the intervention group will participate in pre-post assessments and a 12-week supervised exercise based cardiac rehabilitation program at a designated local Pulse Heart Institute Cardiac Rehabilitation program.

Group II: control groupActive Control1 Intervention

Participants assigned to the control group will participate in pre-post assessments and will maintain usual care and current activity levels.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exercise-based cardiac rehabilitation improves cardiovascular health through structured physical activity, which enhances heart function and reduces inflammation. This is particularly beneficial for AF patients as it can help maintain sinus rhythm and improve overall heart health. Other common treatments for AF include rate control, which uses medications like beta-blockers to maintain a heart rate below 85 beats per minute, and rhythm control, which aims to restore normal heart rhythm through electrical or pharmacologic cardioversion. Anticoagulation therapy is also crucial to prevent stroke by reducing the risk of blood clot formation. Together, these treatments help manage symptoms, reduce complications, and improve the quality of life for AF patients.