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Effect of 3 Years of Exercise on Development of Atrial Fibrillation

This study is currently recruiting participants.
Verified September 2012 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01680302
First received: September 4, 2012
Last updated: September 25, 2012
Last verified: September 2012
History of Changes

September 4, 2012
September 25, 2012
September 2012
December 2015   (final data collection date for primary outcome measure)
Number of persons who develop atrial fibrillation during the 3 year intervention period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
People who already have the diagnosis before randomisation will not be counted.
Same as current
Complete list of historical versions of study NCT01680302 on ClinicalTrials.gov Archive Site
Number of persons who develop atrial fibrillation during the 6 years after randomisation [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of 3 Years of Exercise on Development of Atrial Fibrillation
Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy

This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised do moderate intensity, high intensity 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Behavioral: High intensity exercise
  • Behavioral: Moderate intensity exercise
  • Behavioral: Control
    Advised to follow current guidelines for physical activity, but exercise on their own.
  • Experimental: High intensity exercise
    High intensity exercise(Borg 16) in intervals.
    Intervention: Behavioral: High intensity exercise
  • Experimental: Moderate intensity exercise
    Moderate intensity exercise 3 times a week.
    Intervention: Behavioral: Moderate intensity exercise
  • Experimental: Control group
    Exercise on their own. Follow current guidelines.
    Intervention: Behavioral: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
December 2025
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participating in the "Generation 100" study

Exclusion Criteria:

-
Both
70 Years to 75 Years
Yes
Contact: Vegard Malmo 004772829756 vegard.malmo@ntnu.no
Norway
 
NCT01680302
2012/978b-2
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Study Chair: Jan Paal Loennechen, PhD St. Olavs Hospital
Norwegian University of Science and Technology
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP