Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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:
NCT01673139
First received: August 22, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Behavioral: Interval exercise
Behavioral: Moderate exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in burden of atrial fibrillation [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Burden of atrial fibrillation; measured by Holter monitor and the patient.


Secondary Outcome Measures:
  • Size of left ventricle [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Echocardiographic measures

  • Quality of life [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Measured with SF-36

  • Endothelial function [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Diameter of brachial artery measured by ultrasound.

  • Maximal oxygen uptake [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
  • Atrial extrasystoles [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Measured with Holter monitor

  • Number of hospitalisations with atrial fibrillation as main diagnosis [ Time Frame: Total number during the 3 year intervention period ] [ Designated as safety issue: No ]
  • Total number of electrical cardioversions [ Time Frame: During the 3 years of intervention ] [ Designated as safety issue: No ]
    Number of electrical cardioversions because og atrial fibrillation

  • Change in burden of atrial fibrillation [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Measured by Holter and the patient.

  • Size of left atrium [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Echocardiography

  • Function of left atrium [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Echocardiographic measures

  • Function of left ventricle [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Echocardiographic measures

  • Size of left atrium [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Echocardiographic measures

  • Symptom burden [ Time Frame: At baseline and 3 years ] [ Designated as safety issue: No ]
    Measured with Symptom and Severity Checklist.


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: January 2026
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate exercise
Moderate exercise
Behavioral: Moderate exercise
Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
Experimental: Control
Control group
Behavioral: Control
Given information on recommendations for physical activity.
Experimental: Interval exercise
interval exercise
Behavioral: Interval exercise
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.

  Eligibility

Ages Eligible for Study:   70 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673139

Contacts
Contact: Vegard Malmo 004772829756 vegard.malmo@ntnu.no

Locations
Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway, 7491
Sub-Investigator: Vegard Malmo         
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
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01673139     History of Changes
Other Study ID Numbers: 2012/978b
Study First Received: August 22, 2012
Last Updated: July 28, 2014
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
Exercise

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014