Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673139
• Other study ID #: 2012/978b
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: August 2018

Study information

• Verified date: November 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 75 Years

Eligibility

Inclusion Criteria:

• Included in the "Generation 100 study"

• Atrial fibrillation diagnosis verified by ECG

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• 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.
• Moderate exercise
Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
• Control
Given information on recommendations for physical activity.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in burden of atrial fibrillation	Burden of atrial fibrillation; measured by Holter monitor and the patient.	At baseline and 3 years
Secondary	Size of left ventricle	Echocardiographic measures	At baseline and 3 years
Secondary	Quality of life	Measured with SF-36	At baseline and 3 years
Secondary	Endothelial function	Diameter of brachial artery measured by ultrasound.	At baseline and 3 years
Secondary	Maximal oxygen uptake		At baseline and 3 years
Secondary	Atrial extrasystoles	Measured with Holter monitor	At baseline and 3 years
Secondary	Number of hospitalisations with atrial fibrillation as main diagnosis		Total number during the 3 year intervention period
Secondary	Total number of electrical cardioversions	Number of electrical cardioversions because og atrial fibrillation	During the 3 years of intervention
Secondary	Change in burden of atrial fibrillation	Measured by Holter and the patient.	Baseline and 1 year
Secondary	Size of left atrium	Echocardiography	Baseline and 1 year
Secondary	Function of left atrium	Echocardiographic measures	At baseline and 3 years
Secondary	Function of left ventricle	Echocardiographic measures	At baseline and 3 years
Secondary	Size of left atrium	Echocardiographic measures	At baseline and 3 years
Secondary	Symptom burden	Measured with Symptom and Severity Checklist.	At baseline and 3 years