Atrial Fibrillation ParoxysmalALPNCT03724383
Atrial Fibrillation Lifestyle Project
A study testing Risk Factor Management Consult, Diet Classes and Stress Management Classes in people with Atrial Fibrillation Paroxysmal, run by Teddi Orenstein Lyall at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- Risk Factor Management Consult, Diet Classes and Stress Management Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesCanada
- Study dates
- 6 Sep 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
Oliver Kostanski, MD contact
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
Richmond Hospital Cardiac Rehabilitation
Richmond, British Columbia, V6X 1A2
Andrew Jakubowski, MD, 6042731555, atjakubowski@gmail.com
- Not yet recruiting
Richmond Health Services
Richmond, British Columbia, V6Y 3T6
Christina Salgado, RN, 6042335614, chris.salgado@vch.ca
- Not yet recruiting
Garratt Wellness Centre
Richmond, British Columbia, V7C 3S9
(604) 204-2007
- Recruiting
Richmond Cardiology Clinic
Richmond, British Columbia, V7C 5L9
Teddi Orenstein Lyall, MD, 6042731555, teddi.orenstein@vch.ca
- Not yet recruiting
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
- Not yet recruiting
Live Well Clinic
Vancouver, British Columbia, V6M 3W6
Ali Zentner, MD, 6042693705
- Not yet recruiting
St. Paul's Healthy Heart Program
Vancouver, British Columbia, V6Z 1Y6
Saul Isserow, MD, 6048227955, saul.isserow@vch.ca
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- Risk Factor Management Consult, Diet Classes, Stress Management Classes, Exercise Classes, Home based exercise program
- Keywords
- Non-permanent atrial fibrillation, Non-valvular atrial fibrillation, Nutrition, Diet, Exercise, Physical Activity, Sleep Apnea, Cardiovascular Risk, Obesity, Hypertension, Diabetes, Risk Factor Management
- Medical subject headings
- Atrial Fibrillation, Motor Activity, Sleep Apnea Syndromes, Obesity, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Factor Management ConsultBehavioural
Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.
Diet ClassesBehavioural
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 ClassesBehavioural
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 ClassesOther
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 programOther
The interval and resistance training program will mirror the supervised exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Risk Factor Management Consult; Behavioral: Diet Classes; Behavioral: Stress Management Classes; Other: Exercise Classes; Other: Home based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months and 1 year
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start6 Sep 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teddi Orenstein Lyall
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, Vancouver Coastal Health Research Institute, University of British Columbia
- Responsible party
- Sponsor-investigator, Teddi Orenstein Lyall, University of British Columbia
- Investigators
- Teddi Orenstein Lyall, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724383
- Sponsor's protocol ID
- H18-01441
- Other IDs
- F18-02253
- Acronym
- ALP
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16639472Dorian 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.
PubMed 11028487Hays, 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.
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.
PubMed 26733609Chugh 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.
PubMed 24345399Go 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.
PubMed 11343485Guo 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.
PubMed 24921459Lee 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.
PubMed 23084510Wolowacz 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.
PubMed 21757483Stewart 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.
PubMed 14966048Macle 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.
PubMed 27609430Huxley 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.
PubMed 21444879Carlsson 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.
PubMed 24599014Eshoo 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.
PubMed 19808574Tsang 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.
PubMed 11357793
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Lifestyle Project
- ClinicalTrials.gov ID
- NCT03724383
- Acronym / sponsor ID
- ALP / H18-01441
- Conditions
- Atrial Fibrillation Paroxysmal
- Keywords
- Non-permanent atrial fibrillation, Non-valvular atrial fibrillation, Nutrition, Diet, Exercise, Physical Activity, Sleep Apnea, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Teddi Orenstein LyallUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, Vancouver Coastal Health Research Institute, University of British Columbia
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control arm will receive standard care. |
| Intervention | Experimental | Behavioral: Risk Factor Management Consult, Behavioral: Diet Classes, Behavioral: Stress Management Classes, Other: Exercise Classes, Other: Home based exercise programParticipants 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Factor Management ConsultParticipants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met. | Behavioural | Intervention |
| Diet ClassesGroup 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. | Behavioural | Intervention |
| Stress Management ClassesGroup 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. | Behavioural | Intervention |
| Exercise ClassesGroup 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. | Other | Intervention |
| Home based exercise programThe interval and resistance training program will mirror the supervised exercise. | Other | Intervention |
Primary outcome
Changes in frequency of atrial fibrillation
Time frame: 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
Time frame: 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.
Changes in Quality of Life on SF36
Time frame: 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.
12 secondary outcomes
Changes in number of medications
Time frame: Baseline and 1 year
Systolic and Diastolic Blood Pressure
Time frame: Baseline, 6 months, 1 year
Hemoglobin A1C
Time frame: Baseline, 6 months, 1 year
Body Mass Index
Time frame: Baseline, 6 months, 1 year
Waist Circumference
Time frame: Baseline, 6 months, 1 year
Relative Fat Mass
Time frame: Baseline, 6 months, 1 year
Low density lipoprotein
Time frame: Baseline, 6 months, 1 year
Apnea hypopnea index
Time frame: Baseline, 6 months, 1 year
Metabolic equivalents (METs)
Time frame: Baseline, 6 months, 1 year
Left Atrial Volume Index
Time frame: Baseline,1 year
Diastolic Function Grade
Time frame: Baseline, 1 year
Left Atrial Pressure
Time frame: Baseline, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 16639472Dorian 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.
- Background: PubMed 11028487Dorian 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.
- BackgroundHays, 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: PubMed 26733609Malmo 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.
- Background: PubMed 24345399Chugh 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Kostanski, MD contact
Teddi Orenstein Lyall, MD principal investigator
University of British Columbia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Factor Management Consult, Diet Classes and Stress Management Classes in people with Atrial Fibrillation Paroxysmal, run by Teddi Orenstein Lyall at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy RN Booth, MPH (6044046343, amy.booth@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency of atrial fibrillation (time frame: Baseline to 6 months and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724383, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.