Atrial Fibrillation Lifestyle Project (ALP)

Teddi Orenstein Lyall

Status: Unknown

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Behavioral: Stress Management Classes; Other: Home based exercise program; Other: Exercise Classes; Behavioral: Diet Classes; Behavioral: Risk Factor Management Consult

Study type: Interventional

Funder types: Other

Identifiers

NCT03724383

H18-01441

F18-02253 (Other Grant/Funding Number)

Details and patient eligibility

About

The objectives of the investigators are to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. Participants will be randomized into control or intervention groups. The intervention will receive step trackers, diet counselling, an exercise program, and risk factor modification consultations. Controls will receive step trackers and care as usual. Testing will occur at baseline, six months, and one year.

Full description

Sixty percent of cases of non-valvular AF are associated with other modifiable risk factors, including: obesity, diabetes, hypertension, or sleep apnea. Treating modifiable risk factors has been shown to improve morbidity and mortality in patients with AF. Treatment of AF with antiarrhythmic drugs or catheter ablation has not been shown to improve survival. Recently, small cohort studies combining exercise, diet, and antiarrhythmic medications and/or ablation have shown improvements in cardiovascular risk factors and reduction in AF symptoms and frequency.

The aim of this study is to demonstrate a reduction in frequency and symptoms of AF and improvements in cardiovascular risk factors following a lifestyle intervention in patients with paroxysmal AF. This study uses a reproducible intensive supervised cardiac rehabilitation that includes exercise, diet, and risk factor modification for patients with paroxysmal, non-valvular AF. The investigators expect that a lifestyle intervention will show significant improvement in fitness and weight loss and improvements in AF symptoms and frequency, and cardiovascular risk factors when compared to a control group with paroxysmal AF and similar baseline characteristics who do not receive a diet and exercise program.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. paroxysmal, non-permanent, non-valvular AF. Patients with high burden of AF will be admitted into the study ahead of low burden patients.

   1. Low burden paroxysmal AF is defined as: ≥4 episodes of AF over the past 24 months; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
   2. High burden paroxysmal AF is defined as: ≥ 4 episodes of AF over the past 6 months, with ≥ 2 episodes > 6 hours in duration; episodes terminate spontaneously within 7 days or via cardioversion within 48 hours of onset.
   3. Early persistent AF is defined as: ≥ 2 episodes of AF over the past 24 months; episodes are successfully terminated via cardioversion within 7 days of onset.

2. BMI equal to or greater than 27 kg/m^2, or central obesity using abdominal circumference with ethnic specific values recommended by Canadian diabetes association.

3. one of hypertension or diabetes

Exclusion criteria

1. Permanent AF
2. Estimated survival < 2 years
3. Left ventricular ejection fraction < 40%
4. Weight > 300 lbs, treadmill cannot hold greater weights
5. Inability to walk one city block
6. Severe musculoskeletal or neurological problems making them unable to exercise safely
7. New York Heart Association class 3-4 heart failure
8. Severe aortic valve stenosis
9. Prior mitral valve surgery or severe stenosis or regurgitation
10. Hypertrophic cardiomyopathy
11. Patients with illnesses or medications that already cause atrial fibrillation on their own, such as pericarditis, high doses of prednisone, and hyperthyroidism
12. Any other absolute and relative contraindications to exercise testing
13. Inability to speak and understand English
14. In atrial fibrillation at time of baseline testing
15. Defibrillator present

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in the control arm will receive standard care.

Intervention

Experimental group

Description:

Participants in the intervention group will receive risk factor management consultations and take part in 1-hour biweekly diet classes and stress management classes for the first 3 months. This will be followed by 3 months of 1-hour biweekly high intensity interval training exercise classes. At the 6-month time point, participants will be prescribed a home based exercise program and will have the option of participating in weekly group walking sessions. During the final 6 months, participants will use a step/activity tracker to track their steps and heart rate.

Treatment:

Behavioral: Stress Management Classes

Other: Home based exercise program

Behavioral: Risk Factor Management Consult

Other: Exercise Classes

Behavioral: Diet Classes