Atrial Fibrillation Lifestyle Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Atrial Fibrillation Lifestyle Project

Conditions
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Atrial Fibrillation Paroxysmal

Intervention / Treatment
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* Behavioral: Risk Factor Management Consult
* Behavioral: Diet Classes
* Behavioral: Stress Management Classes
* Other: Exercise Classes
* Other: Home based exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paroxysmal, non-permanent, non-valvular AF. Patients with high burden of AF will be admitted into the study ahead of low burden patients. 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. 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. 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. 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. one of hypertension or diabetes Exclusion Criteria: Permanent AF Estimated survival < 2 years Left ventricular ejection fraction < 40% Weight > 300 lbs, treadmill cannot hold greater weights Inability to walk one city block Severe musculoskeletal or neurological problems making them unable to exercise safely New York Heart Association class 3-4 heart failure Severe aortic valve stenosis Prior mitral valve surgery or severe stenosis or regurgitation Hypertrophic cardiomyopathy Patients with illnesses or medications that already cause atrial fibrillation on their own, such as pericarditis, high doses of prednisone, and hyperthyroidism Any other absolute and relative contraindications to exercise testing Inability to speak and understand English In atrial fibrillation at time of baseline testing Defibrillator present

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel-group randomized controlled trial. Consecutive patients meeting eligibility criteria that are seen for routine cardiology follow-up will be invited to participate in this study. Patients who accept the possibility of diet counseling and exercise program will be randomized and stratified to 'control arm' versus 'intervention arm.' The final study results will be reported after completion of one-year follow up. We will also carry out a mid-study data analysis at six-months. Forty patients will be randomized to control arm and 40 patients randomized to the intervention arm. Intervention will include Phase 1, a six month program including three months of diet counseling combined with home exercise, followed by three months (starting at week 13) of an in-hospital, Cardiac rehabilitation exercise program. Phase 2 of the intervention will include six months of home-based maintenance exercise and diet (starting at week 25). The entire intervention period will be one year.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in the control arm will receive standard care. | |
| Experimental: Intervention<br>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. | Behavioral: Risk Factor Management Consult<br>* Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.<br>Behavioral: Diet Classes<br>* Group nutrition sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention) delivered by a registered dietitian.<br>Behavioral: Stress Management Classes<br>* Group sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention). Techniques taught will include awareness, coping, and relaxation strategies.<br>Other: Exercise Classes<br>* Group sessions delivered two times per week (1 hr each), over 3 month period (months 3-6). Classes will include high intensity interval training, resistance training.<br>Other: Home based exercise program<br>* The interval and resistance training program will mirror the supervised exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in frequency of atrial fibrillation | The frequency of AF will be measured with 48-hour Holter monitor recording, looking at percent of time in AF. | Baseline to 6 months and 1 year | 
| Changes in severity of atrial fibrillation | Assessed using the Canadian Cardiovascular Society Severity in Atrial Fibrillation Scale (CCS-SAF), and the Atrial Fibrillation Symptom Severity Scale (AFSS). The CCS-SAF categorizes severity of atrial fibrillation from Class 0 to Class 4, with 0 being asymptomatic and 4 being severe. On the AFSS, individual symptoms attributable to AF are scored on a five-point Likert scale, such that the total AFSS severity score ranges from 0 to 35, with higher scores indicating increased AFSS. These two scales will be used simultaneously to inform the severity of Atrial Fibrillation. | Baseline to 6 months and 1 year | 
| Changes in Quality of Life on SF36 | The 36-item Short Form Survey Instrument (SF36) measures quality of life. Each question is scored on a Likert scale with varying ranges (0-3, 0-5, etc.). Using a score conversion toolkit, the score for each question is converted to a value out of 100, such that lower scores indicate lower quality of life and higher scores indicate a higher quality of life. Those scores out of 100 can be added to get a score out of 3600, but the quality of life is most often reported as a percent. | Baseline to 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in number of medications | Total number of all anti-arrhythmic agents, anti-hypertensive agents, diabetes and cholesterol lowering medications will be recorded and compared. | Baseline and 1 year | 
| Systolic and Diastolic Blood Pressure | Measured in mmHg. For a normal reading, your blood pressure needs to show a top number (systolic pressure) that's between 90 and less than 120 and a bottom number (diastolic pressure) that's between 60 and less than 80. | Baseline, 6 months, 1 year | 
| Hemoglobin A1C | The hemoglobin A1c test tells you your average level of blood sugar over the past 2 to 3 months. It's also called HbA1c, glycated hemoglobin test, and glycohemoglobin. It is reported in percentages. | Baseline, 6 months, 1 year | 
| Body Mass Index | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. BMI is universally expressed in units of kg/m^2. | Baseline, 6 months, 1 year | 
| Waist Circumference | Waist circumference is an indicator of health risk associated with excess fat around the waist. A waist circumference of 102 centimetres (40 inches) or more in men, or 88 centimetres (35 inches) or more in women, is associated with health problems such as type 2 diabetes, heart disease and high blood pressure | Baseline, 6 months, 1 year | 
| Relative Fat Mass | Relative Fat Mass (RFM) is a measure for the estimation of overweight or obesity in humans. The ratio or the patient's height and waist measurements in meters is multiplied by 20 before being subtracted from a number (shown in bold below) that adjusts for differences in gender and height: RFM for adult males: 64 - (20 x height in meters divided waist circumference in meters) RFM for adult females:76 - (20 x height in metres divided by waist circumference in meters) | Baseline, 6 months, 1 year | 
| Low density lipoprotein | Low-density lipoprotein (LDL) is one of the body's lipoproteins and an important carrier of cholesterol. LDL is an important marker for the risk of developing heart disease. LDL cholesterol levels should be less than 100 mg/dL. Levels of 100 to 129 mg/dL are acceptable for people with no health issues but may be of more concern for those with heart disease or heart disease risk factors. A reading of 130 to 159 mg/dL is borderline high and 160 to 189 mg/dL is high. | Baseline, 6 months, 1 year | 
| Apnea hypopnea index | The Apnea Hypopnea Index (AHI) is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of obstructive sleep apnea is classified as follows: None/Minimal: AHI < 5 per hour Mild: AHI ≥ 5, but < 15 per hour Moderate: AHI ≥ 15, but < 30 per hour Severe: AHI ≥ 30 per hour | Baseline, 6 months, 1 year | 
| Metabolic equivalents (METs) | Fitness will be classified using metabolic equivalents (METs). One MET is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min. The energy cost of an activity can be determined by dividing the relative oxygen cost of the activity (ml O2/kg/min) x by 3.5. This study will measure metabolic equivalents achieved on exercise stress test. | Baseline, 6 months, 1 year | 
| Left Atrial Volume Index | The Left Atrial Volume Index (LAVI) is the left atrial volume relative to Body Surface Area (BSA), and is reported in mL/m^2. Ranges of LAVI Reference Range 16-28 Mildly Abnormal 29-33 Moderately Abnormal 34-39 Severely Abnormal ≥40 | Baseline,1 year | 
| Diastolic Function Grade | here are four grades of diastolic dysfunction as described below. Echocardiography is the gold standard to diagnose diastolic dysfunction. Grade I (impaired relaxation): This is a normal finding and occurs in nearly 100% of individuals by the age of 60. Grade II (pseudonormal): This is pathological and results in elevated left atrial pressures. Grade III (reversible restrictive): This results in significantly elevated left atrial pressures. Grade IV (fixed restrictive): This indicates a poor prognosis and very elevated left atrial pressures. | Baseline, 1 year | 
| Left Atrial Pressure | Left atrial pressure (LAP) can be estimated by measuring the systolic blood pressure and the maximum mitral regurgitation velocity by spectral Doppler provided that there is no significant gradient across the aortic valve. Left Atrial Pressure is reported in mmHg | Baseline, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-permanent atrial fibrillation, Non-valvular atrial fibrillation, Nutrition, Diet, Exercise, Physical Activity, Sleep Apnea, Cardiovascular Risk, Obesity, Hypertension, Diabetes, Risk Factor Management