A Lifestyle Modification Program for Secondary Prevention of Atrial Fibrillation: A Pilot Study

Abstract Background Lifestyle modification programs, such as cardiac rehabilitation, may reduce atrial fibrillation (AF) burden and improve quality of life (QOL), but remain unproven. The objective of this pilot study was to assess feasibility, acceptability, and preliminary effectiveness of an exercise and nutrition-based cardiac rehabilitation-like program for AF patients. Methods We enrolled overweight adults aged ≥ 30 years with symptomatic AF in a 12-week cardiac lifestyle group program, including 6 virtual and 6 in-person visits. All visits included discussion and education about nutrition, exercise, and behavior modification. In-person visits included supervised aerobic exercise and strength training. Outcomes at baseline and 12 weeks included feasibility of participation, acceptability, change in weight and BMI, and changes in survey-based AF burden, symptoms, and QOL. Results From 84 invitees, 11 (13.1%) were enrolled (mean age 64; baseline BMI 38 kg/m 2 ); 9 (82%) completed the program. Patients attended an average of 9.7 (81%) visits (Range: 6–11). Mean weight loss was 9.1 pounds (Range: 0–16); mean BMI decrease was 1.4 kg/m 2 (Range: 0-2.6). Patients found the program helpful overall: all reported making diet and exercise changes during the program. Compared to baseline, patients reported decreased AF burden (12.9 vs. 11.7, p = 0.03) and symptom (10.1 vs. 5.6, p = 0.003) scores at the conclusion of the program. Patients also reported increased QOL overall (68.9 vs. 86.4, p = 0.001) Conclusions Participation in a cardiac rehab-like program was feasible and acceptable for overweight patients with symptomatic AF. Results suggest preliminary effectiveness of the program for reducing AF burden and symptoms and increasing QOL.


Introduction
Atrial brillation (AF) is the most common cardiac arrhythmia, is associated with a 5-fold increased risk of stroke, a 1.5-2 fold increase in all-cause mortality, and is further associated with signi cant morbidity and risk of hospitalization. [1][2][3][4] Lifestyle modi cation may represent an opportunity to improve management of this chronic condition.
Lifestyle modi cation programs, such as cardiac rehabilitation, may reduce AF symptoms and progression, as well as improve quality of life, but remain unproven. 5 The American Heart Association has identi ed lifestyle modi cation in AF as an important therapeutic avenue that has been "underrecognized, underused and understudied" and noted the need for improved implementation strategies to deliver these therapies. 5 Despite promising evidence, exercise-based cardiac rehabilitation is not part of routine care for patients with AF. 5 Existing studies of lifestyle modi cation and secondar prevention of AF have been small, largely short-term, and may not be sustainable for subjects after the research study ends.
In this pilot study, we examined the feasibility, acceptability, and preliminary effectiveness of an exercise and nutrition-based cardiac lifestyle behavioral program for patients with symptomatic AF. We plan to conduct a future pragmatic randomized trial of patients with symptomatic, paroxysmal AF to a cardiac lifestyle program compared to usual care. In this trial, we will examine the effectiveness of the intervention on decreasing AF burden and symptoms, as well as how well the bene ts of the intervention persist over a 12-month period.

Design and setting
Eligible patients were overweight or obese (body mass index [BMI] ≥ 28 kg/m 2 ) adults aged ≥ 30 years with symptomatic paroxysmal AF seen by an electrophysiologist at Massachusetts General Hospital.
Patients were excluded if asymptomatic, scheduled for catheter ablation, or if their physician did not think they could participate in an exercise program. Potentially eligible patients were identi ed from an electronic health record query. Research staff conducted an initial chart review to remove those not eligible, and nal eligibility was con rmed by the treating physician.
For patients not excluded by their physician, we sent an introductory letter and study information sheet with an option to opt out. A week later, a research assistant contacted patients by phone to assess interest in study participation. Interested patients completed informed consent.

Intervention
Following consent, patients were enrolled in a 12-week cardiac lifestyle group program, modeled from cardiac rehabilitation 5 , which included 6 virtual and 6 in-person visits. This clinical program was available as part of routine care to patients with metabolic syndrome but was not available solely because of an AF diagnosis. Consented patients were scheduled for an initial in-person evaluation with a team physician, that included: detailed history and physical exam, review of cardiac risk factors and cardiac exam, nutritional assessment, comprehensive weight and diet history, exercise history, lipid pro le, body composition assessment, and determination of percent body fat and BMI.
Visits during the 12-week program included 1-hour of group discussion and didactic education about nutrition, exercise, and behavior modi cation led by a physician and a dietitian. In-person visits also included 1-hour of supervised aerobic exercise and strength training.

Outcomes
All outcomes were assessed at 12 weeks. Primary outcomes were feasibility and acceptability. Feasibility outcomes included the proportion of study visits completed (mean, median, minimum, maximum), the proportion of patients who completed the program, and the proportion of eligible patients who expressed interest in participating. Acceptability was assessed by survey following completion of the program and included questions about satisfaction with the program overall and with speci c program components.
Secondary preliminary effectiveness outcomes included changes from baseline in weight, BMI, surveybased AF burden and symptoms 6 , and quality of life (QOL) 7 . AF burden and symptoms was assessed at baseline and follow-up by survey using the Atrial Fibrillation Severity Scale (AFSS), 6 and quality of life was assessed with the AF Effect on Quality-Of-Life Questionnaire (AFEQT). 7 Changes in outcomes from baseline were evaluated with paired sample t-tests. The sample size goal was 10-12 patients. The research protocol was approved by the Mass General Brigham Institutional Review Board. Participants provided written informed consent to participate.
Patients found the program helpful overall, and all reported making diet and exercise changes ( Table 1). Patients indicated that reviewing program notes/handouts (78%), periodic check-ins with program staff (67%), and logging diet and exercise daily (67%) would help maintain lifestyle changes.

Discussion
Prior to conducting a large-scale pragmatic trial of an exercise and nutrition-based cardiac lifestyle modi cation program for secondary prevention of AF, this pilot study demonstrated that participation in a lifestyle modi cation program was feasible and acceptable for overweight and obese patients with symptomatic AF. Importantly, results suggest preliminary effectiveness of the program for reducing AF burden and symptoms and increasing QOL.

Comparisons to existing research
There is growing evidence that lifestyle modi cations have a signi cant impact on management of AF. 5 Randomized studies examining the impact of lifestyle modi cation and cardiac rehabilitation on secondary prevention of AF have been limited in size and duration, with few evaluating sustainability. 8 The ACTIVE-AF randomized trial demonstrated that a tailored aerobic-based exercise program reduced AF symptom severity and improved maintenance of sinus rhythm. 9 These bene ts were achieved in the absence of weight loss. Other studies have reported decreased AF burden and symptoms with aggressive risk factor reduction, including weight loss. 10,11 Interventions evaluating the bene ts of interventions that include both exercise and nutrition components warrant further investigation. Our pilot trial demonstrated feasibility and preliminary effectiveness of a hybrid, health clinic and virtual home-based, intervention to promote lifestyle modi cation related to both exercise and nutrition for secondary prevention of AF. Such a model may increase participation and be more sustainable than an entirely facility-based approach. 12 Future research should evaluate the e cacy of a hybrid-based exercise and nutrition-based program for AF related (symptoms, recurrence, progression) and clinical (hospitalizations, mortality) endpoints in a multi-site, adequately powered clinical trial.

Strengths and limitations
There was signi cant interest in study participation among eligible patients. More than half the patients reached by phone expressed interest in participating in the study and we quickly met our sample size goal. Among our 11 enrolled subjects, there was good retention with 9 completing the full 12-week program.
Our sample size of 11 enrolled subjects is small. Available funding for this pilot study was not signi cant enough to expand capacity of this clinical program. While our sample did have adequate representation of women (n = 5 of 11), we did not have an ethnically or racially diverse sample and did not have information about educational attainment or income. Additionally, we were unable to evaluate long-term sustainability of changes in diet and/or exercise beyond the 12-week program, or maintaining improvements in AF burden/symptoms and QOL. However, evaluating sustainability is a goal of the larger trial.

Conclusions
This study demonstrates that enrolling overweight and obese patients with symptomatic AF in an exercise and nutrition-based cardiac lifestyle modi cation program for secondary prevention of AF is both acceptable to patients and feasible. An adequately powered pragmatic randomized trial comparing such a program to usual care appears possible.  Flow diagram of patient identi cation, eligibility con rmation, recruitment, and enrollment