Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
SINTEF Health Research
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01673139
First received: August 22, 2012
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Atrial Fibrillation
Behavioral: Interval exercise
Behavioral: Moderate exercise
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of 3 Years of Exercise in Patients With 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:
  • Change in burden of atrial fibrillation [ Time Frame: At baseline and 3 years ]
    Burden of atrial fibrillation; measured by Holter monitor and the patient.


Secondary Outcome Measures:
  • Size of left ventricle [ Time Frame: At baseline and 3 years ]
    Echocardiographic measures

  • Quality of life [ Time Frame: At baseline and 3 years ]
    Measured with SF-36

  • Endothelial function [ Time Frame: At baseline and 3 years ]
    Diameter of brachial artery measured by ultrasound.

  • Maximal oxygen uptake [ Time Frame: At baseline and 3 years ]
  • Atrial extrasystoles [ Time Frame: At baseline and 3 years ]
    Measured with Holter monitor

  • 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 ]
    Number of electrical cardioversions because og atrial fibrillation

  • Change in burden of atrial fibrillation [ Time Frame: Baseline and 1 year ]
    Measured by Holter and the patient.

  • Size of left atrium [ Time Frame: Baseline and 1 year ]
    Echocardiography

  • Function of left atrium [ Time Frame: At baseline and 3 years ]
    Echocardiographic measures

  • Function of left ventricle [ Time Frame: At baseline and 3 years ]
    Echocardiographic measures

  • Size of left atrium [ Time Frame: At baseline and 3 years ]
    Echocardiographic measures

  • Symptom burden [ Time Frame: At baseline and 3 years ]
    Measured with Symptom and Severity Checklist.


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: January 2028
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate exercise
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.

  Eligibility

Ages Eligible for Study:   70 Years to 75 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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: NCT01673139

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
SINTEF Health Research
Investigators
Study Chair: Jan Paal Loennechen, PhD St. Olavs Hospital
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01673139     History of Changes
Other Study ID Numbers: 2012/978b
Study First Received: August 22, 2012
Last Updated: September 15, 2016

Keywords provided by Norwegian University of Science and Technology:
Atrial fibrillation
Exercise

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 28, 2017