Aerobic Interval Training in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of aerobic interval training in patients with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial fibrillation and symptoms are reduced.

Detailed Description
-----------------
Long term endurance sport practice is associated with a higher incidence of atrial fibrillation. Moderate/light physical activity seems to be associated with a lower incidence. The underlying mechanisms are uncertain. In order to examine the effect of training in this population, the investigators will perform a randomised controlled study with aerobic interval training in patients with paroxysmal/persistent atrial fibrillation.

Official Title
-----------------
Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Behavioral: Interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training. Exclusion Criteria: Performing high intensity training (pulse >90% of max) for more than 2 times a week. Moderate intensity training more than 30 min, more than 3 times a week Previous open heart surgery EF <40% Significant aorta stenosis Mitral insufficiency, >gr. 2 Pacemaker Earlier coronary intervention and not complete revascularization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interval training<br>Interval training | Behavioral: Interval training<br>* Aerobic interval training will be performed with 4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 12 weeks.<br>|
| No Intervention: Control<br>Live as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in burden of atrial fibrillation | Burden of atrial fibrillation(number of episodes, duration(percent of the day)) continually measured, and reported by the patient. Analysed for the patients in total, with sub analysis in the groups of paroxysmal and persistent AF and in those with a low burden of atrial fibrillation vs. those with a larger burden. | Baseline and 4 weeks after ended intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of left atrium and ventricle | Atrial and ventricular size will be evaluated by echocardiography and MRI. | Baseline and after ended intervention period(12 weeks) | 
| Blood samples | Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured. | Baseline and after ended intervention period(12 weeks) | 
| Endothelial function | FMD | Baseline and after ended intervention period(12 weeks) | 
| Atrial extrasystoles | Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training. | Baseline and after ended intervention period(12 weeks) | 
| Ablation procedure | Duration of ablation, number of ablation points, success. | Measured during the ablation procedure (day 1) | 
| Maximal oxygen uptake |  | Baseline and after ended intervention period(12 weeks) | 
| Atrial and ventricular function | Atrial and ventricular function measured by MR and echocardiography | Baseline and after ended intervention period(12 weeks) | 
| Fibrosis | Fibrosis in left atrium and left ventricle measured by MRI. | Baseline and after ended intervention period(12 weeks) | 
| Quality of life | Measured with SF-36, Symptom and Severity Checklist and EHRA score of AF- related symptoms | Baseline and after ended intervention period(12 weeks) | 
| Burden of atrial fibrillation in the intervention period | The intervention period is divided into 3 periods of 4 weeks each. The mean burden of atrial fibrillation(percent of time with atrial fibrillation) and number of episodes in each of those periods will be assessed to see if exercise changes the amount of fibrillation. | Week 1-4, 5-8 and 9-12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Motor activity