Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F18-02253 | Other Grant/Funding Number | Vancouver Coastal Health Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vancouver Coastal Health | OTHER_GOV |
| Vancouver Coastal Health Research Institute | OTHER |
| University of British Columbia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in the control arm will receive standard care. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk Factor Management Consult | Behavioral | Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met. |
| 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 |
| 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 |
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy RN Booth, MPH | Contact | 6044046343 | amy.booth@vch.ca | |
| Oliver Kostanski, MD | Contact | oliverkostanski@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Teddi Orenstein Lyall, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Hospital Cardiac Rehabilitation | Not yet recruiting | Richmond | British Columbia | V6X 1A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16639472 | Background | Dorian P, Cvitkovic SS, Kerr CR, Crystal E, Gillis AM, Guerra PG, Mitchell LB, Roy D, Skanes AC, Wyse DG. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. Can J Cardiol. 2006 Apr;22(5):383-6. doi: 10.1016/s0828-282x(06)70922-9. | |
| 11028487 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 31, 2022 | |
| Reset | Mar 16, 2023 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2018 | Oct 12, 2018 | Prot_SAP_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 31, 2022 | Mar 16, 2023 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009043 | Motor Activity |
| D012891 | Sleep Apnea Syndromes |
| D009765 | Obesity |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
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.
Not provided
Not provided
The investigators involved in analyzing test results or treating patients are blinded to the participant's study group.
| Diet Classes | Behavioral | 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. |
|
| Stress Management Classes | Behavioral | 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. |
|
| Exercise Classes | Other | 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. |
|
| Home based exercise program | Other | The interval and resistance training program will mirror the supervised exercise. |
|
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 |
| Richmond Health Services | Not yet recruiting | Richmond | British Columbia | V6Y 3T6 | Canada |
|
| Garratt Wellness Centre | Not yet recruiting | Richmond | British Columbia | V7C 3S9 | Canada |
|
| Richmond Cardiology Clinic | Recruiting | Richmond | British Columbia | V7C 5L9 | Canada |
|
| Gordon and Leslie Diamond Health Care Centre | Not yet recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Live Well Clinic | Not yet recruiting | Vancouver | British Columbia | V6M 3W6 | Canada |
|
| St. Paul's Healthy Heart Program | Not yet recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
|
| Dorian P, Jung W, Newman D, Paquette M, Wood K, Ayers GM, Camm J, Akhtar M, Luderitz B. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol. 2000 Oct;36(4):1303-9. doi: 10.1016/s0735-1097(00)00886-x. |
| Background | Hays, R. D.,&Stewart, A. L. (1992). Construct validity of MOS health measures. In A. L. Stewart&J. E. Ware (eds.), Measuring functioning and well-being: The Medical Outcomes Study approach (pp. 325-342), Durham, NC: Duke University Press. |
| 26733609 | Background | Malmo V, Nes BM, Amundsen BH, Tjonna AE, Stoylen A, Rossvoll O, Wisloff U, Loennechen JP. Aerobic Interval Training Reduces the Burden of Atrial Fibrillation in the Short Term: A Randomized Trial. Circulation. 2016 Feb 2;133(5):466-73. doi: 10.1161/CIRCULATIONAHA.115.018220. Epub 2016 Jan 5. |
| 24345399 | Background | Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17. |
| 11343485 | Background | Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370. |
| 24921459 | Background | Guo Y, Tian Y, Wang H, Si Q, Wang Y, Lip GYH. Prevalence, incidence, and lifetime risk of atrial fibrillation in China: new insights into the global burden of atrial fibrillation. Chest. 2015 Jan;147(1):109-119. doi: 10.1378/chest.14-0321. |
| 23084510 | Background | Lee GA, Stub D, Ling H. Atrial fibrillation in the elderly -- not a benign condition. Int Emerg Nurs. 2012 Oct;20(4):221-7. doi: 10.1016/j.ienj.2012.05.003. Epub 2012 Jul 4. |
| 21757483 | Background | Wolowacz SE, Samuel M, Brennan VK, Jasso-Mosqueda JG, Van Gelder IC. The cost of illness of atrial fibrillation: a systematic review of the recent literature. Europace. 2011 Oct;13(10):1375-85. doi: 10.1093/europace/eur194. Epub 2011 Jul 14. |
| 14966048 | Background | Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart. 2004 Mar;90(3):286-92. doi: 10.1136/hrt.2002.008748. |
| 27609430 | Background | Macle L, Cairns J, Leblanc K, Tsang T, Skanes A, Cox JL, Healey JS, Bell A, Pilote L, Andrade JG, Mitchell LB, Atzema C, Gladstone D, Sharma M, Verma S, Connolly S, Dorian P, Parkash R, Talajic M, Nattel S, Verma A; CCS Atrial Fibrillation Guidelines Committee. 2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2016 Oct;32(10):1170-1185. doi: 10.1016/j.cjca.2016.07.591. Epub 2016 Sep 6. |
| 21444879 | Background | Huxley RR, Lopez FL, Folsom AR, Agarwal SK, Loehr LR, Soliman EZ, Maclehose R, Konety S, Alonso A. Absolute and attributable risks of atrial fibrillation in relation to optimal and borderline risk factors: the Atherosclerosis Risk in Communities (ARIC) study. Circulation. 2011 Apr 12;123(14):1501-8. doi: 10.1161/CIRCULATIONAHA.110.009035. Epub 2011 Mar 28. |
| 24599014 | Background | Carlsson AC, Wandell P, Sundquist K, Johansson SE, Sundquist J. Effects of prescribed antihypertensives and other cardiovascular drugs on mortality in patients with atrial fibrillation and hypertension: a cohort study from Sweden. Hypertens Res. 2014 Jun;37(6):553-9. doi: 10.1038/hr.2014.32. Epub 2014 Mar 6. |
| 19808574 | Background | Eshoo S, Ross DL, Thomas L. Impact of mild hypertension on left atrial size and function. Circ Cardiovasc Imaging. 2009 Mar;2(2):93-9. doi: 10.1161/CIRCIMAGING.108.793190. Epub 2009 Jan 26. |
| 11357793 | Background | Tsang TS, Barnes ME, Bailey KR, Leibson CL, Montgomery SC, Takemoto Y, Diamond PM, Marra MA, Gersh BJ, Wiebers DO, Petty GW, Seward JB. Left atrial volume: important risk marker of incident atrial fibrillation in 1655 older men and women. Mayo Clin Proc. 2001 May;76(5):467-75. doi: 10.4065/76.5.467. |
| 14697466 | Background | Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Risks for atrial fibrillation and congestive heart failure in patients >/=65 years of age with abnormal left ventricular diastolic relaxation. Am J Cardiol. 2004 Jan 1;93(1):54-8. doi: 10.1016/j.amjcard.2003.09.012. |
| 12466506 | Background | Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328. |
| 23419659 | Background | Neumann T, Wojcik M, Berkowitsch A, Erkapic D, Zaltsberg S, Greiss H, Pajitnev D, Lehinant S, Schmitt J, Hamm CW, Pitschner HF, Kuniss M. Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success. Europace. 2013 Aug;15(8):1143-9. doi: 10.1093/europace/eut021. Epub 2013 Feb 17. |
| 27590435 | Background | Miyazaki S, Taniguchi H, Kusa S, Nakamura H, Hachiya H, Hirao K, Iesaka Y. Five-year follow-up outcome after catheter ablation of persistent atrial fibrillation using a sequential biatrial linear defragmentation approach: What does atrial fibrillation termination during the procedure imply? Heart Rhythm. 2017 Jan;14(1):34-40. doi: 10.1016/j.hrthm.2016.08.041. Epub 2016 Aug 30. |
| 26113406 | Background | Pathak RK, Elliott A, Middeldorp ME, Meredith M, Mehta AB, Mahajan R, Hendriks JM, Twomey D, Kalman JM, Abhayaratna WP, Lau DH, Sanders P. Impact of CARDIOrespiratory FITness on Arrhythmia Recurrence in Obese Individuals With Atrial Fibrillation: The CARDIO-FIT Study. J Am Coll Cardiol. 2015 Sep 1;66(9):985-96. doi: 10.1016/j.jacc.2015.06.488. Epub 2015 Jun 22. |
| 29049041 | Background | Hong KL, Glover BM. The impact of lifestyle intervention on atrial fibrillation. Curr Opin Cardiol. 2018 Jan;33(1):14-19. doi: 10.1097/HCO.0000000000000470. |
| 28694186 | Background | Elliott AD, Maatman B, Emery MS, Sanders P. The role of exercise in atrial fibrillation prevention and promotion: Finding optimal ranges for health. Heart Rhythm. 2017 Nov;14(11):1713-1720. doi: 10.1016/j.hrthm.2017.07.001. Epub 2017 Jul 8. |
| Background | Jonasson D, Irvine S, Starkey S, Su S, Johal R, Sweeney P, et al. SCREENING FOR OBSTRUCTIVE SLEEP APNEA (OSA) IN ATRIAL FIBRILLATION (AF): WHAT'S THE BEST TEST? Can J Cardiol [Internet]. 2017 Oct 1 [cited 2018 Jan 24];33(10):S195. |
| Background | Froelicher V, Myers J. Exercise and the Heart 5th edition. 5th ed. Pioli SF, editor. Philadelphia: Saunders; 2006. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |