Effect of 3 Years of Exercise on Development of Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014