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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.
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.
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.
Richmond Hospital Cardiac Rehabilitation
Richmond, British Columbia, Canada
NOT_YET_RECRUITINGRichmond Health Services
Richmond, British Columbia, Canada
NOT_YET_RECRUITINGGarratt Wellness Centre
Richmond, British Columbia, Canada
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months and 1 year
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.
Time frame: 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.
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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.
The interval and resistance training program will mirror the supervised exercise.
Richmond Cardiology Clinic
Richmond, British Columbia, Canada
RECRUITINGGordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGLive Well Clinic
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGSt. Paul's Healthy Heart Program
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, 1 year