Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments high intensity exercise, moderate intensity exercise, control
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date September 2012
End date December 2025
Trial size 4000 participants
Trial identifier NCT01680302, 2012/978b-2

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
High intensity exercise(Borg 16) in intervals.
high intensity exercise
(Experimental)
Moderate intensity exercise 3 times a week.
moderate intensity exercise
(Experimental)
Exercise on their own. Follow current guidelines.
control
Advised to follow current guidelines for physical activity, but exercise on their own.

Primary Outcomes

Measure
Number of persons who develop atrial fibrillation during the 3 year intervention period
time frame: 3 years

Secondary Outcomes

Measure
Number of persons who develop atrial fibrillation during the 6 years after randomisation
time frame: 6 years

Eligibility Criteria

Male or female participants from 70 years up to 75 years old.

Inclusion Criteria: - Participating in the "Generation 100" study Exclusion Criteria:

Additional Information

Official title Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.