Training in Atrial Fibrillation - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborators:	St. Olavs Hospital SINTEF Health Research
Information provided by (Responsible Party):	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01325675

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Behavioral: Interval training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Change in burden of atrial fibrillation [ Time Frame: Baseline and 4 weeks after ended intervention period ] [ Designated as safety issue: No ]
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:

Size of left atrium and ventricle [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Atrial and ventricular size will be evaluated by echocardiography and MRI.
Blood samples [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.
Endothelial function [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
FMD
Atrial extrasystoles [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training.
Ablation procedure [ Time Frame: Measured during the ablation procedure (day 1) ] [ Designated as safety issue: No ]
Duration of ablation, number of ablation points, success.
Maximal oxygen uptake [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Atrial and ventricular function [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Atrial and ventricular function measured by MR and echocardiography
Fibrosis [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Fibrosis in left atrium and left ventricle measured by MRI.
Quality of life [ Time Frame: Baseline and after ended intervention period(12 weeks) ] [ Designated as safety issue: No ]
Measured with SF-36, Symtpom and Severitiy Checklist and EHRA score of AF- related symptoms
Burden of atrial fibrillation in the intervention period [ Time Frame: Week 1-4, 5-8 and 9-12 ] [ Designated as safety issue: No ]
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 asssessed to see if exercise changes the amount of fibrillation.

Estimated Enrollment:	50
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Interval training Interval training	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.
No Intervention: Control Live as usual

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325675

Contacts

Contact: Vegard Malmo, MSc	004772829756	vegard.malmo@ntnu.no
Contact: Jan Pål Loennechen, PhD

Locations

Norway
Norwegian University of Science and Technology	Recruiting
Trondheim, Norway, 7491
Contact: Vegard Malmo vegard.malmo@ntnu.no

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

SINTEF Health Research

Investigators

Study Chair:	Jan Paal Loennechen, PhD	St. Olavs Hospital
Study Chair:	Ulrik Wisløff, PhD	Norwegian University of Science and Technology

More Information

No publications provided

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01325675 History of Changes
Other Study ID Numbers:	2010/3345-1(REK)
Study First Received:	March 23, 2011
Last Updated:	February 3, 2012
Health Authority:	Norway: The National Committees for Research Ethics in Norway Norway: Norwegian Social Science Data Services Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Atrial fibrillation
Motor activity

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012