Effect of 3 Years of Exercise on Development of Atrial Fibrillation

This study is currently recruiting participants.
Verified April 2014 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: April 16, 2014
Last verified: April 2014
  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
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: September 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   70 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participating in the "Generation 100" study

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680302

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
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: NCT01680302     History of Changes
Other Study ID Numbers: 2012/978b-2
Study First Received: September 4, 2012
Last Updated: April 16, 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
Prevention
Exercise

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

ClinicalTrials.gov processed this record on April 21, 2014