Aerobic Interval Training in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325675
• Other study ID #: 2010/3345-1(REK)
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: January 7, 2016
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Interval training
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.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Malmo V, Nes BM, Amundsen BH, Tjonna AE, Stoylen A, Rossvoll O, Wisloff U, Loennechen JP. Aerobic Interval Training Reduces the Burden of Atrial Fibrillation in the Short Term: A Randomized Trial. Circulation. 2016 Feb 2;133(5):466-73. doi: 10.1161/CIRCUL — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	Blood samples	Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.	Baseline and after ended intervention period(12 weeks)	No
Secondary	Endothelial function	FMD	Baseline and after ended intervention period(12 weeks)	No
Secondary	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)	No
Secondary	Ablation procedure	Duration of ablation, number of ablation points, success.	Measured during the ablation procedure (day 1)	No
Secondary	Maximal oxygen uptake		Baseline and after ended intervention period(12 weeks)	No
Secondary	Atrial and ventricular function	Atrial and ventricular function measured by MR and echocardiography	Baseline and after ended intervention period(12 weeks)	No
Secondary	Fibrosis	Fibrosis in left atrium and left ventricle measured by MRI.	Baseline and after ended intervention period(12 weeks)	No
Secondary	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)	No
Secondary	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	No