Aerobic Interval Training in Patients With Atrial Fibrillation

January 7, 2016 updated by: Norwegian University of Science and Technology

Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in burden of atrial fibrillation
Time Frame: 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.
Baseline and 4 weeks after ended intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of left atrium and ventricle
Time Frame: Baseline and after ended intervention period(12 weeks)
Atrial and ventricular size will be evaluated by echocardiography and MRI.
Baseline and after ended intervention period(12 weeks)
Blood samples
Time Frame: Baseline and after ended intervention period(12 weeks)
Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.
Baseline and after ended intervention period(12 weeks)
Endothelial function
Time Frame: Baseline and after ended intervention period(12 weeks)
FMD
Baseline and after ended intervention period(12 weeks)
Atrial extrasystoles
Time Frame: Baseline and after ended intervention period(12 weeks)
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
Time Frame: Measured during the ablation procedure (day 1)
Duration of ablation, number of ablation points, success.
Measured during the ablation procedure (day 1)
Maximal oxygen uptake
Time Frame: Baseline and after ended intervention period(12 weeks)
Baseline and after ended intervention period(12 weeks)
Atrial and ventricular function
Time Frame: Baseline and after ended intervention period(12 weeks)
Atrial and ventricular function measured by MR and echocardiography
Baseline and after ended intervention period(12 weeks)
Fibrosis
Time Frame: Baseline and after ended intervention period(12 weeks)
Fibrosis in left atrium and left ventricle measured by MRI.
Baseline and after ended intervention period(12 weeks)
Quality of life
Time Frame: Baseline and after ended intervention period(12 weeks)
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
Time Frame: 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.
Week 1-4, 5-8 and 9-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 23, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/3345-1(REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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