A Lifestyle Modification Program for Secondary Prevention of Atrial Fibrillation: Introductory Findings

Atrial fibrillation (AF), the most common cardiac arrhythmia, is associated with a fivefold increased risk of stroke, and with significant morbidity and risk of hospitalization.1,2 Lifestyle modification may represent an opportunity to improve management of this chronic condition.

Lifestyle modification programs, such as cardiac rehabilitation, may reduce AF symptoms and progression, as well as improve quality of life (QoL), but remain unproven.3–5 The American Heart Association has identified lifestyle modification 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.3 Despite promising evidence, exercise-based cardiac rehabilitation is not part of routine care for patients with AF.3

In this study, we examined the feasibility, acceptability, and preliminary effectiveness of an exercise and nutrition-based cardiac lifestyle behavioral program for patients with symptomatic AF.

METHODS

Eligible patients were overweight or obese (body mass index ≥28 kg/m²) adults aged ≥30 yr with symptomatic paroxysmal AF seen 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. Research staff conducted an initial chart review to remove those not eligible, and final eligibility was confirmed by the treating 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 and obtain informed consent.

INTERVENTION

Following consent, patients were enrolled in a 12-wk cardiac lifestyle group program, modeled from cardiac rehabilitation,3 which included six virtual and six in-person visits. Consented patients were scheduled for an initial in-person evaluation with a team physician and dietitian.

Visits during the 12-wk program included 1-hr group discussion and didactic education about nutrition, exercise, and behavior modification led by a physician and a dietitian. In-person visits also included 1-hr supervised aerobic exercise and strength training.

OUTCOMES

All outcomes were assessed at 12 wk. Primary outcomes were feasibility and acceptability. Feasibility outcomes included the proportion of (1) patients who expressed interest in participating, (2) patients who completed the program, and (3) study visits completed. Acceptability was assessed by survey following completion of the program.

Secondary preliminary effectiveness outcomes included changes from baseline in weight, body mass index, AF burden and symptoms,6 and QoL.7 Atrial fibrillation burden and symptoms were assessed by survey using the Atrial Fibrillation Severity Scale (AFSS),6 and QoL using the AF Effect on Quality-of-Life Questionnaire (AFEQT).7 Changes in values between baseline and follow-up 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.

RESULTS

Among 96 potentially eligible patients, 12 (13%) were excluded by their physician. Among 84 patients sent recruitment letters, 33 (39%) expressed interest in the program, 32 (38%) declined participation, 19 (23%) were never reached by phone, and 11 (13%) enrolled. The mean age of enrollees was 64.2 ± 9.9 yr, five (46%) were female, 11 (100%) were White, and the mean body mass index was 38.2 ± 6.2 kg/m² (range: 29.9-48.9 kg/m²). Of 11 enrollees, nine (82%) completed the program and all study surveys. The mean number of visits attended was 9.7 ± 1.6 of 12 (81%) (median: 10 [9-11]).

All patients indicated they found the program helpful overall, all reported making diet and exercise changes, and most thought they could maintain changes to diet (89%) and exercise (77%). 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.

Mean weight loss in those completing the program was 9.1 ± 4.7 lb (range: 0-16 lb, P = .002); mean body mass index decreased 1.4 ± 0.7 kg/m² (range: 0-2.6 kg/m², P = .002). Compared to baseline, patients reported decreased AF burden and symptoms at the conclusion of the program. Patients also reported increased QoL overall and for all QoL subscales (Table).

Table. Patient-Reported Atrial Fibrillation Burden, Symptoms, and Quality of Life at Baseline and Follow-up.

	Baseline (n = 9)	Follow-up (n = 9)	Change	P Value
Atrial Fibrillation Severity Scale (AFSS)
Burden (scale range: 3-30)	12.9 ± 5.0	11.7 ± 4.4	−1.2 95% CI, −2.3 to −0.2	.03
Symptoms (scale range: 0-35)	10.1 ± 3.0	5.6 ± 3.3	−4.6 95% CI, −7.0 to −2.1	.003
Atrial Fibrillation Effect on Quality of Life (AFEQT) (scale range: 0-100)a
Overall	68.9 ± 10.1	86.4 ± 6.9	17.5 95% CI, 9.5-25.5	.001
Symptoms	85.2 ± 13.2	92.6 ± 6.7	7.4 95% CI, −0.1 to 14.9	.052
Daily activities	60.2 ± 14.4	84.2 ± 8.7	24.1 95% CI, 14.1-34.0	<.001
Treatment	67.6 ± 12.4	85.2 ± 8.4	17.6 95% CI, 7.3-27.9	.004

^aHigher scores indicate increased quality of life.

DISCUSSION

This study demonstrated that participation in a lifestyle modification program was feasible and acceptable for patients who were overweight or obese with symptomatic AF. Importantly, results suggest preliminary effectiveness of the program for reducing AF burden and symptoms and increasing QoL.

Randomized studies examining the impact of lifestyle modification and cardiac rehabilitation on secondary prevention of AF have been limited in size and duration, with few evaluating sustainability.4,5,8 The ACTIVE-AF trial demonstrated that a tailored aerobic-based exercise program reduced AF symptom severity and improved maintenance of sinus rhythm.9 These benefits 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 The benefits of interventions that include both exercise and nutrition components warrant further investigation. Our study demonstrated feasibility and preliminary effectiveness of a hybrid, health clinic and virtual home-based, intervention to promote lifestyle modification 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. Future research should evaluate the efficacy of a hybrid-based exercise and nutrition-based program for AF-related (symptoms, recurrence, and progression) and clinical (hospitalizations, mortality) endpoints in a multisite, adequately powered clinical trial.

There was significant interest in study participation. 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 nine completing the full 12-wk program.

Our sample size of 11 enrolled subjects is small. Available funding for this pilot study was not significant enough to expand capacity of this clinical program. We were unable to evaluate sustainability of lifestyle changes beyond the 12-wk program, or maintaining improvements in AF burden/symptoms and QoL.

CONCLUSIONS

This study demonstrates that enrolling patients who were overweight or obese with symptomatic AF in a cardiac lifestyle modification program for secondary prevention of AF is both acceptable to patients and feasible. The next step should be an adequately powered pragmatic randomized trial comparing such a program to usual care.