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Completed

NCT Number: NCT01325675

Aerobic Interval Training in Patients With 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7491, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval Training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Blood samples

    Time frame: Baseline and after ended intervention period(12 weeks)

    Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.

  3. Endothelial function

    Time frame: Baseline and after ended intervention period(12 weeks)

    FMD

  4. 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.

  5. Ablation procedure

    Time frame: Measured during the ablation procedure (day 1)

    Duration of ablation, number of ablation points, success.

  6. Maximal oxygen uptake

    Time frame: Baseline and after ended intervention period(12 weeks)

  7. Atrial and ventricular function

    Time frame: Baseline and after ended intervention period(12 weeks)

    Atrial and ventricular function measured by MR and echocardiography

  8. Fibrosis

    Time frame: Baseline and after ended intervention period(12 weeks)

    Fibrosis in left atrium and left ventricle measured by MRI.

  9. 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

  10. 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • SINTEF Health Research
  • St. Olavs Hospital

Registry information

Official study title

Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 30, 2011
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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