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Effect of 3 Years of Exercise on Development of Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680302
First Posted: September 7, 2012
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition Intervention
Atrial Fibrillation Behavioral: High intensity exercise Behavioral: Moderate intensity exercise Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of 3 Years of Exercise on Development of 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:
  • Number of persons who develop atrial fibrillation during the 3 year intervention period [ Time Frame: 3 years ]
    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 [ Time Frame: 6 years ]

Estimated Enrollment: 4000
Study Start Date: September 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High intensity exercise
High intensity exercise(Borg 16) in intervals.
Behavioral: High intensity exercise
Experimental: Moderate intensity exercise
Moderate intensity exercise 3 times a week.
Behavioral: Moderate intensity exercise
Experimental: Control group
Exercise on their own. Follow current guidelines.
Behavioral: Control
Advised to follow current guidelines for physical activity, but exercise on their own.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 75 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participating in the "Generation 100" study

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680302


Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Chair: Jan Paal Loennechen, PhD St. Olavs Hospital
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01680302     History of Changes
Other Study ID Numbers: 2012/978b-2
First Submitted: September 4, 2012
First Posted: September 7, 2012
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Norwegian University of Science and Technology:
Atrial fibrillation
Prevention
Exercise

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