Atrial Fibrillation Lifestyle Project (ALP)

October 26, 2018 updated by: Teddi Orenstein Lyall
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Richmond, British Columbia, Canada, V6X 1A2
        • Not yet recruiting
        • Richmond Hospital Cardiac Rehabilitation
        • Contact:
      • Richmond, British Columbia, Canada, V6Y 3T6
        • Not yet recruiting
        • Richmond Health Services
        • Contact:
      • Richmond, British Columbia, Canada, V7C 3S9
        • Not yet recruiting
        • Garratt Wellness Centre
        • Contact:
          • Phone Number: (604) 204-2007
      • Richmond, British Columbia, Canada, V7C 5L9
        • Recruiting
        • Richmond Cardiology Clinic
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Not yet recruiting
        • Gordon and Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6M 3W6
        • Not yet recruiting
        • Live Well Clinic
        • Contact:
          • Ali Zentner, MD
          • Phone Number: 6042693705
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Not yet recruiting
        • St. Paul's Healthy Heart Program
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. paroxysmal, non-permanent, non-valvular AF. Patients with high burden of AF will be admitted into the study ahead of low burden patients.

    1. 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.
    2. 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.
    3. 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.
  2. 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.
  3. one of hypertension or diabetes

Exclusion Criteria:

  1. Permanent AF
  2. Estimated survival < 2 years
  3. Left ventricular ejection fraction < 40%
  4. Weight > 300 lbs, treadmill cannot hold greater weights
  5. Inability to walk one city block
  6. Severe musculoskeletal or neurological problems making them unable to exercise safely
  7. New York Heart Association class 3-4 heart failure
  8. Severe aortic valve stenosis
  9. Prior mitral valve surgery or severe stenosis or regurgitation
  10. Hypertrophic cardiomyopathy
  11. Patients with illnesses or medications that already cause atrial fibrillation on their own, such as pericarditis, high doses of prednisone, and hyperthyroidism
  12. Any other absolute and relative contraindications to exercise testing
  13. Inability to speak and understand English
  14. In atrial fibrillation at time of baseline testing
  15. Defibrillator present

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants in the control arm will receive standard care.
Experimental: 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.
Behavioral: Risk Factor Management Consult
Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.
Behavioral: Diet Classes
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.
Behavioral: Stress Management Classes
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.
Other: Exercise Classes
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.
Other: Home based exercise program
The interval and resistance training program will mirror the supervised exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months and 1 year
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.
Baseline to 6 months and 1 year
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.
Baseline to 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in number of medications
Time Frame: Baseline and 1 year
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
Time Frame: Baseline, 6 months, 1 year

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
Time Frame: Baseline, 6 months, 1 year

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
Time Frame: Baseline, 6 months, 1 year
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
Time Frame: Baseline, 6 months, 1 year
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
Time Frame: Baseline, 6 months, 1 year

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
Time Frame: Baseline, 6 months, 1 year

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
Time Frame: Baseline, 6 months, 1 year

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)
Time Frame: Baseline, 6 months, 1 year

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
Time Frame: Baseline,1 year

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
Time Frame: Baseline, 1 year

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
Time Frame: Baseline, 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teddi Orenstein Lyall

Collaborators

University of British Columbia
Vancouver Coastal Health Research Institute
Vancouver Coastal Health

Investigators

  • Principal Investigator: Teddi Orenstein Lyall, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18-01441
  • F18-02253 (Other Grant/Funding Number: Vancouver Coastal Health Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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