Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: Moderate exercise; Behavioral: Control; Behavioral: Interval exercise

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Included in the "Generation 100 study"
• Atrial fibrillation diagnosis verified by ECG

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate exercise	Behavioral: Moderate exercise; Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
Experimental: Control; Control group	Behavioral: Control; Given information on recommendations for physical activity.
Experimental: Interval exercise; interval exercise	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in burden of atrial fibrillation	Burden of atrial fibrillation; measured by Holter monitor and the patient.	At baseline and 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; SINTEF Health Research
• Investigators: Study Chair: Jan Paal Loennechen, PhD, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 27, 2012

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2012/978b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No