NCT03724383

Atrial Fibrillation Lifestyle Project

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Teddi Orenstein Lyall · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-06
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2018-10-30
• Last updated: 2018-10-30

Locations

7 sites across 1 country: Canada