Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

This study is currently recruiting participants.
Verified January 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: January 27, 2014
Last verified: January 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
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: January 27, 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 April 16, 2014