Atrial Fibrillation Lifestyle Project

Not Applicable

• Conditions: Atrial Fibrillation Paroxysmal
• Interventions: Behavioral: Risk Factor Management Consult; Behavioral: Diet Classes; Behavioral: Stress Management Classes; Other: Exercise Classes; Other: Home based exercise program

• Registration Number: NCT03724383
• Lead Sponsor: Teddi Orenstein Lyall

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-06
• Status Verified: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-26
• Last Update Submitted: 2018-10-26
• Study First Posted: 2018-10-30
• Last Update Posted: 2018-10-30
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Risk Factor Management Consult	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.
Intervention	Diet Classes	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.
Intervention	Stress Management Classes	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.
Intervention	Exercise Classes	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.
Intervention	Home based exercise program	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.

Primary Outcome Measures

Name	Time	Method
Changes in Quality of Life on SF36	Baseline to 6 months and 1 year	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.
Changes in frequency of atrial fibrillation	Baseline to 6 months and 1 year	The frequency of AF will be measured with 48-hour Holter monitor recording, looking at percent of time in AF.
Changes in severity of atrial fibrillation	Baseline to 6 months and 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Changes in number of medications	Baseline and 1 year	Total number of all anti-arrhythmic agents, anti-hypertensive agents, diabetes and cholesterol lowering medications will be recorded and compared.
Systolic and Diastolic Blood Pressure	Baseline, 6 months, 1 year	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.
Hemoglobin A1C	Baseline, 6 months, 1 year	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.
Body Mass Index	Baseline, 6 months, 1 year	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.
Waist Circumference	Baseline, 6 months, 1 year	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
Relative Fat Mass	Baseline, 6 months, 1 year	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)
Low density lipoprotein	Baseline, 6 months, 1 year	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.
Apnea hypopnea index	Baseline, 6 months, 1 year	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
Metabolic equivalents (METs)	Baseline, 6 months, 1 year	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.
Left Atrial Volume Index	Baseline,1 year	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
Diastolic Function Grade	Baseline, 1 year	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.
Left Atrial Pressure	Baseline, 1 year	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

Trial Locations

Locations (7)

Richmond Hospital Cardiac Rehabilitation; 🇨🇦 Richmond, British Columbia, Canada

Live Well Clinic; 🇨🇦 Vancouver, British Columbia, Canada

Garratt Wellness Centre; 🇨🇦 Richmond, British Columbia, Canada

Richmond Cardiology Clinic; 🇨🇦 Richmond, British Columbia, Canada

Gordon and Leslie Diamond Health Care Centre; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Healthy Heart Program; 🇨🇦 Vancouver, British Columbia, Canada

Richmond Health Services; 🇨🇦 Richmond, British Columbia, Canada