Atrial Fibrillation Lifestyle Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Changes in Quality of Life on SF36
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators involved in analyzing test results or treating patients are blinded to the participant's study group.
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Participants in the control arm will receive standard care.
Intervention
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.
干预措施: Risk Factor Management Consult (Behavioral)
Intervention
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.
干预措施: Diet Classes (Behavioral)
Intervention
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.
干预措施: Stress Management Classes (Behavioral)
Intervention
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.
干预措施: Exercise Classes (Other)
Intervention
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.
干预措施: Home based exercise program (Other)
结局指标
主要结局
Changes in Quality of Life on SF36
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Changes in number of medications(Baseline and 1 year)
- Systolic and Diastolic Blood Pressure(Baseline, 6 months, 1 year)
- Hemoglobin A1C(Baseline, 6 months, 1 year)
- Body Mass Index(Baseline, 6 months, 1 year)
- Waist Circumference(Baseline, 6 months, 1 year)
- Relative Fat Mass(Baseline, 6 months, 1 year)
- Low density lipoprotein(Baseline, 6 months, 1 year)
- Apnea hypopnea index(Baseline, 6 months, 1 year)
- Metabolic equivalents (METs)(Baseline, 6 months, 1 year)
- Left Atrial Volume Index(Baseline,1 year)
- Diastolic Function Grade(Baseline, 1 year)
- Left Atrial Pressure(Baseline, 1 year)
研究者
Teddi Orenstein Lyall
Cardiologist, VCH-Richmond and Clinical Assistant Professor, Department of Medicine, University of British Columbia
University of British Columbia