Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments interval exercise, moderate exercise, control
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date September 2012
End date August 2018
Trial size 150 participants
Trial identifier NCT01673139, 2012/978b

Summary

This is a substudy of "Generation 100". The investigators will follow the persons with atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial fibrillation, symptoms, use of health services or echocardiographic findings.

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)
Moderate exercise
moderate exercise
Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
(Experimental)
Control group
control
Given information on recommendations for physical activity.
(Experimental)
interval exercise
interval exercise
4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.

Primary Outcomes

Measure
Change in burden of atrial fibrillation
time frame: At baseline and 3 years

Secondary Outcomes

Measure
Size of left ventricle
time frame: At baseline and 3 years
Quality of life
time frame: At baseline and 3 years
Endothelial function
time frame: At baseline and 3 years
Maximal oxygen uptake
time frame: At baseline and 3 years
Atrial extrasystoles
time frame: At baseline and 3 years
Number of hospitalisations with atrial fibrillation as main diagnosis
time frame: Total number during the 3 year intervention period
Total number of electrical cardioversions
time frame: During the 3 years of intervention
Change in burden of atrial fibrillation
time frame: Baseline and 1 year
Size of left atrium
time frame: Baseline and 1 year
Function of left atrium
time frame: At baseline and 3 years
Function of left ventricle
time frame: At baseline and 3 years
Size of left atrium
time frame: At baseline and 3 years
Symptom burden
time frame: At baseline and 3 years

Eligibility Criteria

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

Inclusion Criteria: - Included in the "Generation 100 study" - Atrial fibrillation diagnosis verified by ECG Exclusion Criteria:

Additional Information

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