Aerobic Interval Training in Patients With Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Behavioral: Interval training

• Registration Number: NCT01325675
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-04
• Primary Completion: 2013-08
• Study Completion: 2014-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interval training	Interval training	Interval training

Primary Outcome Measures

Name	Time	Method
Change in burden of atrial fibrillation	Baseline and 4 weeks after ended intervention period	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.

Secondary Outcome Measures

Name	Time	Method
Endothelial function	Baseline and after ended intervention period(12 weeks)	FMD
Atrial extrasystoles	Baseline and after ended intervention period(12 weeks)	Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training.
Ablation procedure	Measured during the ablation procedure (day 1)	Duration of ablation, number of ablation points, success.
Maximal oxygen uptake	Baseline and after ended intervention period(12 weeks)
Atrial and ventricular function	Baseline and after ended intervention period(12 weeks)	Atrial and ventricular function measured by MR and echocardiography
Fibrosis	Baseline and after ended intervention period(12 weeks)	Fibrosis in left atrium and left ventricle measured by MRI.
Quality of life	Baseline and after ended intervention period(12 weeks)	Measured with SF-36, Symptom and Severity Checklist and EHRA score of AF- related symptoms
Burden of atrial fibrillation in the intervention period	Week 1-4, 5-8 and 9-12	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.
Size of left atrium and ventricle	Baseline and after ended intervention period(12 weeks)	Atrial and ventricular size will be evaluated by echocardiography and MRI.
Blood samples	Baseline and after ended intervention period(12 weeks)	Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway