Recruiting

Atrial Fibrillation

Sponsor:

Teddi Orenstein Lyall

Code:

NCT03724383

Conditions

Atrial Fibrillation Paroxysmal

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Risk Factor Management Consult

Diet Classes

Stress Management Classes

Exercise Classes

Home based exercise program

Study Details

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

Study ID

NCT03724383

Start date

Sep 6, 2018

Status verified date

Oct, 2018

Completion date

Apr, 2020

Anticipated

Primary completion date

Apr, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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.

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.

Home based exercise program

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

Primary outcome measure

  • Changes in frequency of atrial fibrillation [ Time Frame: Baseline to 6 months and 1 year ]
  • Changes in severity of atrial fibrillation [ Time Frame: Baseline to 6 months and 1 year ]
  • Changes in Quality of Life on SF36 [ Time Frame: Baseline to 6 months and 1 year ]

Central Contacts and Locations

Central contacts

Oliver Kostanski, MD

oliverkostanski@gmail.com

Locations

Richmond Cardiology Clinic

Recruiting

Richmond, British Columbia, Canada, V7C 5L9

Contacts

Teddi Orenstein Lyall, MD

6042731555teddi.orenstein@vch.ca

More Information

Sponsor

Teddi Orenstein Lyall

Last update posted

Oct 30, 2018

Last verified

Oct, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Teddi Orenstein Lyall on 2018-10-30.