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Completed

NCT Number: NCT01673139

Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

This is a substudy of "Generation 100". The investigators will follow the persons with atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial fibrillation, symptoms, use of health services or echocardiographic findings.

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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

70 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7491, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Included in the "Generation 100 study"
  • Atrial fibrillation diagnosis verified by ECG

Exclusion criteria

-

Treatment and study plan

Interval exercise

Behavioral

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 3 years.

moderate exercise

Behavioral

Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.

Control

Behavioral

Given information on recommendations for physical activity.

Primary outcomes

  1. Change in burden of atrial fibrillation

    Time frame: At baseline and 3 years

    Burden of atrial fibrillation; measured by Holter monitor and the patient.

Secondary outcomes

  1. Size of left ventricle

    Time frame: At baseline and 3 years

    Echocardiographic measures

  2. Quality of life

    Time frame: At baseline and 3 years

    Measured with SF-36

  3. Endothelial function

    Time frame: At baseline and 3 years

    Diameter of brachial artery measured by ultrasound.

  4. Maximal oxygen uptake

    Time frame: At baseline and 3 years

  5. Atrial extrasystoles

    Time frame: At baseline and 3 years

    Measured with Holter monitor

  6. Number of hospitalisations with atrial fibrillation as main diagnosis

    Time frame: Total number during the 3 year intervention period

  7. Total number of electrical cardioversions

    Time frame: During the 3 years of intervention

    Number of electrical cardioversions because og atrial fibrillation

  8. Change in burden of atrial fibrillation

    Time frame: Baseline and 1 year

    Measured by Holter and the patient.

  9. Size of left atrium

    Time frame: Baseline and 1 year

    Echocardiography

  10. Function of left atrium

    Time frame: At baseline and 3 years

    Echocardiographic measures

  11. Function of left ventricle

    Time frame: At baseline and 3 years

    Echocardiographic measures

  12. Size of left atrium

    Time frame: At baseline and 3 years

    Echocardiographic measures

  13. Symptom burden

    Time frame: At baseline and 3 years

    Measured with Symptom and Severity Checklist.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • SINTEF Health Research
  • St. Olavs Hospital

Registry information

Official study title

Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2012
Registry last updated
Nov 19, 2018

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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