Back to resultsEffect of 3 Years of Exercise on Development of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity exercise
Moderate intensity exercise
Control
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Prevention, Exercise
Eligibility Criteria
Inclusion Criteria:
- Participating in the "Generation 100" study
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
High intensity exercise
Moderate intensity exercise
Control group
Arm Description
High intensity exercise(Borg 16) in intervals.
Moderate intensity exercise 3 times a week.
Exercise on their own. Follow current guidelines.
Outcomes
Primary Outcome Measures
Number of persons who develop atrial fibrillation during the 3 year intervention period
People who already have the diagnosis before randomisation will not be counted.
Secondary Outcome Measures
Number of persons who develop atrial fibrillation during the 6 years after randomisation
Full Information
NCT ID
NCT01680302
First Posted
September 4, 2012
Last Updated
September 16, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01680302
Brief Title
Effect of 3 Years of Exercise on Development of Atrial Fibrillation
Official Title
Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Prevention, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity exercise
Arm Type
Experimental
Arm Description
High intensity exercise(Borg 16) in intervals.
Arm Title
Moderate intensity exercise
Arm Type
Experimental
Arm Description
Moderate intensity exercise 3 times a week.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Exercise on their own. Follow current guidelines.
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Advised to follow current guidelines for physical activity, but exercise on their own.
Primary Outcome Measure Information:
Title
Number of persons who develop atrial fibrillation during the 3 year intervention period
Description
People who already have the diagnosis before randomisation will not be counted.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of persons who develop atrial fibrillation during the 6 years after randomisation
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participating in the "Generation 100" study
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 on Development of Atrial Fibrillation
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