Back to resultsEffect of 3 Years of Exercise in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interval exercise
Moderate exercise
Control
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Exercise
Eligibility Criteria
Inclusion Criteria:
- Included in the "Generation 100 study"
- Atrial fibrillation diagnosis verified by ECG
Exclusion Criteria:
-
Sites / Locations
- Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Moderate exercise
Control
Interval exercise
Arm Description
Moderate exercise
Control group
interval exercise
Outcomes
Primary Outcome Measures
Change in burden of atrial fibrillation
Burden of atrial fibrillation; measured by Holter monitor and the patient.
Secondary Outcome Measures
Size of left ventricle
Echocardiographic measures
Quality of life
Measured with SF-36
Endothelial function
Diameter of brachial artery measured by ultrasound.
Maximal oxygen uptake
Atrial extrasystoles
Measured with Holter monitor
Number of hospitalisations with atrial fibrillation as main diagnosis
Total number of electrical cardioversions
Number of electrical cardioversions because og atrial fibrillation
Change in burden of atrial fibrillation
Measured by Holter and the patient.
Size of left atrium
Echocardiography
Function of left atrium
Echocardiographic measures
Function of left ventricle
Echocardiographic measures
Size of left atrium
Echocardiographic measures
Symptom burden
Measured with Symptom and Severity Checklist.
Full Information
NCT ID
NCT01673139
First Posted
August 22, 2012
Last Updated
November 16, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research
1. Study Identification
Unique Protocol Identification Number
NCT01673139
Brief Title
Effect of 3 Years of Exercise in Patients With Atrial Fibrillation
Official Title
Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate exercise
Arm Type
Experimental
Arm Description
Moderate exercise
Arm Title
Control
Arm Type
Experimental
Arm Description
Control group
Arm Title
Interval exercise
Arm Type
Experimental
Arm Description
interval exercise
Intervention Type
Behavioral
Intervention Name(s)
Interval exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate exercise
Intervention Description
Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Given information on recommendations for physical activity.
Primary Outcome Measure Information:
Title
Change in burden of atrial fibrillation
Description
Burden of atrial fibrillation; measured by Holter monitor and the patient.
Time Frame
At baseline and 3 years
Secondary Outcome Measure Information:
Title
Size of left ventricle
Description
Echocardiographic measures
Time Frame
At baseline and 3 years
Title
Quality of life
Description
Measured with SF-36
Time Frame
At baseline and 3 years
Title
Endothelial function
Description
Diameter of brachial artery measured by ultrasound.
Time Frame
At baseline and 3 years
Title
Maximal oxygen uptake
Time Frame
At baseline and 3 years
Title
Atrial extrasystoles
Description
Measured with Holter monitor
Time Frame
At baseline and 3 years
Title
Number of hospitalisations with atrial fibrillation as main diagnosis
Time Frame
Total number during the 3 year intervention period
Title
Total number of electrical cardioversions
Description
Number of electrical cardioversions because og atrial fibrillation
Time Frame
During the 3 years of intervention
Title
Change in burden of atrial fibrillation
Description
Measured by Holter and the patient.
Time Frame
Baseline and 1 year
Title
Size of left atrium
Description
Echocardiography
Time Frame
Baseline and 1 year
Title
Function of left atrium
Description
Echocardiographic measures
Time Frame
At baseline and 3 years
Title
Function of left ventricle
Description
Echocardiographic measures
Time Frame
At baseline and 3 years
Title
Size of left atrium
Description
Echocardiographic measures
Time Frame
At baseline and 3 years
Title
Symptom burden
Description
Measured with Symptom and Severity Checklist.
Time Frame
At baseline and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included in the "Generation 100 study"
Atrial fibrillation diagnosis verified by ECG
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Paal Loennechen, PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7491
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Effect of 3 Years of Exercise in Patients With Atrial Fibrillation
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