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Training in Atrial Fibrillation

This study is currently recruiting participants.
Verified November 2012 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
St. Olavs Hospital
SINTEF Health Research
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01325675
First received: March 23, 2011
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  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:

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, Symptom and Severity 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 assessed 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: November 27, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

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 16, 2013