Atrial Fibrillation (AF) and Physical Exercise (EXAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hvidovre University Hospital
Sponsor:
Collaborators:
Sygekassernes Helsefond
Eva og Henry Frænkels Mindefond
Sanofi
Thorkild Steenbecks Legat
Toyota-Fonden
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Information provided by (Responsible Party):
Ane Katrine Skielboe, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01817998
First received: March 21, 2013
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

Background and study concept:

Atrial fibrillation is the new global epidemic in cardiology. With improved survival from other cardiovascular diseases and longer living in general, the incidence and prevalence of AF rise dramatically in all developed countries with an estimated life time risk of one in four for all people above the age of 40 years. Similarly in Denmark, the prevalence is estimated to almost double within 2020. It is a fatal arrhythmia with doubled mortality compared to patients with normal sinus rhythm; this primarily caused by an increased risk of stroke and heart failure. In particular stroke is a feared complication with a 70% risk of fatal outcome or lasting handicaps and immense costs for each patient as well as in terms of health costs.

Moreover, many AF patients experience a variety of symptoms and have markedly reduced quality of life. Opposed to heart failure patients and patients who have suffered from a myocardial infarction, AF patients are not offered any sort of rehabilitation when diagnosed.

Pharmacological treatment of the arrhythmia is challenging. Most often, individual and careful risk evaluation including ultrasound of the heart is obligatory to choose optimal treatment strategy and prophylactic anticoagulation. In case a new anti-arrhythmic drug is started to restore and maintain sinus rhythm, hospitalization for at least two days with heart rhythm monitoring is required to detect any possible potentially dangerous or even fatal arrhythmia as a side effect to the treatment. Additionally, the first new oral anti-arrhythmic AF drug introduced for more than twenty-five years proved to be hazardous in a high-risk AF population and is now only used with strict precautions.

To explore the role of alternative treatment strategies and to renew handling of cardiac arrhythmia, we have therefore set out to study the role of physical exercise in AF patients.

Our specific study aims are to examine:

  1. The effect of physical exercise on AF burden
  2. The effect of physical exercise on the risk of cardiovascular hospitalization

Method:

Our study is an interventional, randomized exercise study. 60 patients older than 18 years with ECG-documented AF will be included if written informed consent is obtained. They will be randomized 1:1 to moderate-severe (80-85% of max capacity) or low intensity (50% of max capacity) training. Exclusion criteria are language barrier, illness inherent with an expected survival shorter than a year, other reasons preventing the patient from training, revealed serious cardiac disease during pre-tests, AF ablation within one year, permanent AF.

Both groups are first participating in a nurse-led educational and care program. The program is built on two individual consultations and one team consultation with focus on education in AF.

The patients will be thoroughly examined before randomization and after ended training period with special ultrasound of the heart, ECG-monitored test of maximal oxygen uptake on ergometer bicycle, 24 hours measurement of blood pressure and pulse, and blood samples. They will all be taught to use home ECG recorders, a new handheld device. The patients will send ECG's twice daily and if the experience cardiac symptoms for 5 months (during exercise and two months after).

When randomized the patients will be divided in teams of ten and trained on separate teams, so the physiotherapist closely can guide the patients in training at the correct intensity level.

Measurements:

During and after physical exercise the burden of atrial fibrillation is measured by tele-ECG i.e. number of ECGs with atrial fibrillation divided by total number of ECGs. ECG reporting begins after four weeks of physical exercise and continues 2 months after last training session.

Recording of hospitalization begins after randomization and continues one year after last training session. All hospitalizations caused by AF or related to the AF disease (relapse of AF, heart failure, stroke, new anti-arrhythmic medication, elective electrical cardioversion, complications to anticoagulation, pacemaker implantation) are recorded. Also, total days in hospital are registered.

The AF population is growing on a global scale and the disease attracts immense interest on all international cardiology congresses. New knowledge of the effect of training for the general population as well as the effect in the setting of established disease could have paramount effect for prognosis, quality of life, and health costs as pharmacological treatment is AF still holds challenges.


Condition Intervention
Atrial Fibrillation
Other: Physical Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Physical Exercise in Patients With Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Change from baseline in burden of atrial fibrillation at 12 weeks measured by tele-ECG i.e. number og ECGs with atrial fibrillation divided by total number of ECGs [ Time Frame: Pre-training (baseline) and after 12 weeks of training (primary endpoint) ] [ Designated as safety issue: No ]
    Further assessments: 2 months after end of training.


Secondary Outcome Measures:
  • Change from baseline in hospitalization related to atrial fibrillation at one year after end of training measured by number of admissions/contacts registered in the patients records. [ Time Frame: Pre-training (baseline) and one year after end of training (primary endpoint) ] [ Designated as safety issue: No ]
    Hospitalization or contact to emergency rooms registered in the patients records caused by atrial fibrillation, heart failure, stroke, atrial fibrillation, ablation, side effects to atrial fibrillation medication, and pacemaker implantation.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Endurance Physical Exercise
High Intensity endurance physical exercise, intensity measured on Borg Scale with progression from Borg 10-13 (50% of maximum) to 17-18 (80 % of maximum). One hour of exercise twice weekly for 12 weeks supervised by physiotherapists.
Other: Physical Exercise
Comparison of high versus low intensity physical exercise in patients with atrial fibrillation.
Active Comparator: Low Intensity Endurance Physical Exercise
Low Intensity endurance physical exercise, intensity measured on Borg Scale, Borg 10-13 (50% of maximum) with no progression in intensity. One hour of exercise twice weekly for 12 weeks supervised by physiotherapists.
Other: Physical Exercise
Comparison of high versus low intensity physical exercise in patients with atrial fibrillation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • paroxysmal or persistent atrial fibrillation documented on ECG
  • male and female of age 18 and above
  • written concent

Exclusion Criteria:

  • established permanent atrial fibrillation
  • language barrier
  • severe health conditions making physical exercise impossible or life expectancy shorter than one year
  • signs of severe cardiac disease during inclusion tests
  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: NCT01817998

Contacts
Contact: Ane Katrine Skielboe, MD +45-40630928 a.k.skielboe@gmail.com
Contact: Ulrik Dixen, Consultant +45-38622804 ulrik.dixen@regionh.dk

Locations
Denmark
Department of Cardiology, Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Denmark, 2650
Contact: Ane Katrine Skielboe, MD    +45-40630928    a.k.skielboe@gmail.com   
Contact: Ulrik Dixen, Consultant    +45-38622804    ulrik.dixen@regionh.dk   
Principal Investigator: Ane Katrine Skielboe, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Sygekassernes Helsefond
Eva og Henry Frænkels Mindefond
Sanofi
Thorkild Steenbecks Legat
Toyota-Fonden
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Investigators
Principal Investigator: Ulrik Dixen, Consultant Copenhagen University Hospital, Hvidovre
  More Information

No publications provided

Responsible Party: Ane Katrine Skielboe, MD, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01817998     History of Changes
Other Study ID Numbers: H-2-2012-048
Study First Received: March 21, 2013
Last Updated: March 25, 2013
Health Authority: Denmark: Local Ethical Committee, Copenhagen

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

ClinicalTrials.gov processed this record on October 19, 2014