Atrial Fibrillation Lifestyle Project

NCT03724383 | Unknown DMC

• 2 other identifiers: H18-01441F18-02253
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

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.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

Non-permanent atrial fibrillation; Non-valvular atrial fibrillation; Nutrition; Diet; Exercise; Physical Activity; Sleep Apnea; Cardiovascular Risk; Obesity; Hypertension; Diabetes; Risk Factor Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

Study Arms (2)

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.

Behavioral: Risk Factor Management Consult; Behavioral: Diet Classes; Behavioral: Stress Management Classes; Other: Exercise Classes; Other: Home based exercise program

Interventions

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.

Intervention

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.

Intervention

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.

Intervention

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.

Intervention

Home based exercise program OTHER

The interval and resistance training program will mirror the supervised exercise.

Intervention

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teddi Orenstein Lyall: lead
• Vancouver Coastal Health: collaborator
• Vancouver Coastal Health Research Institute: collaborator
• University of British Columbia: collaborator

Study Sites (7)

Richmond Hospital Cardiac Rehabilitation

Richmond, British Columbia, V6X 1A2, Canada

NOT YET RECRUITING

Richmond Health Services

Richmond, British Columbia, V6Y 3T6, Canada

NOT YET RECRUITING

Garratt Wellness Centre

Richmond, British Columbia, V7C 3S9, Canada

NOT YET RECRUITING

Richmond Cardiology Clinic

Richmond, British Columbia, V7C 5L9, Canada

RECRUITING

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

NOT YET RECRUITING

Live Well Clinic

Vancouver, British Columbia, V6M 3W6, Canada

NOT YET RECRUITING

St. Paul's Healthy Heart Program

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

Related Publications (24)

• 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.

  PMID: 16639472 BACKGROUND

• 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.

  PMID: 11028487 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.

  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.

  PMID: 26733609 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.

  PMID: 24345399 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.

  PMID: 11343485 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.

  PMID: 24921459 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.

  PMID: 23084510 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.

  PMID: 21757483 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.

  PMID: 14966048 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.

  PMID: 27609430 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.

  PMID: 21444879 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.

  PMID: 24599014 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.

  PMID: 19808574 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.

  PMID: 11357793 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.

  PMID: 14697466 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.

  PMID: 12466506 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.

  PMID: 23419659 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.

  PMID: 27590435 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.

  PMID: 26113406 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.

  PMID: 29049041 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.

  PMID: 28694186 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.

  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity; Sleep Apnea Syndromes; Obesity; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Teddi Orenstein Lyall, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy RN Booth, MPH

CONTACT

6044046343; amy.booth@vch.ca

Oliver Kostanski, MD

CONTACT

oliverkostanski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators involved in analyzing test results or treating patients are blinded to the participant's study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist, VCH-Richmond and Clinical Assistant Professor, Department of Medicine, University of British Columbia

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 30, 2018
• Study Start: September 6, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)