Atrial Fibrillation (AF) and Physical Exercise

NCT01817998 | Completed

• 1 other identifier: H-2-2012-048
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  Further assessments: 2 months after end of training.

  Pre-training (baseline) and after 12 weeks of training (primary endpoint)

Secondary Outcomes (1)

• 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.

  Pre-training (baseline) and one year after end of training (primary endpoint)

Study Arms (2)

High Intensity Endurance Physical Exercise

EXPERIMENTAL

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

Low Intensity Endurance Physical Exercise

ACTIVE COMPARATOR

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

Interventions

Physical Exercise OTHER

Comparison of high versus low intensity physical exercise in patients with atrial fibrillation.

High Intensity Endurance Physical Exercise; Low Intensity Endurance Physical Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• established permanent atrial fibrillation
• language barrier
• severe health conditions making physical exercise impossible or life expectancy shorter than one year

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Sygekassernes Helsefond: collaborator
• Eva og Henry Frænkels Mindefond: collaborator
• Sanofi: collaborator
• Thorkild Steenbecks Legat: collaborator
• Toyota-Fonden: collaborator
• Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation: collaborator

Study Sites (1)

Department of Cardiology, Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Skielboe AK, Bandholm TQ, Hakmann S, Mourier M, Kallemose T, Dixen U. Cardiovascular exercise and burden of arrhythmia in patients with atrial fibrillation - A randomized controlled trial. PLoS One. 2017 Feb 23;12(2):e0170060. doi: 10.1371/journal.pone.0170060. eCollection 2017.

  PMID: 28231325 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ulrik Dixen, Consultant

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

DK (1)