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Aerobic Interval Training in Patients With Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Motor activity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training.

Exclusion Criteria:

  • Performing high intensity training (pulse >90% of max) for more than 2 times a week.
  • Moderate intensity training more than 30 min, more than 3 times a week
  • Previous open heart surgery
  • EF <40%
  • Significant aorta stenosis
  • Mitral insufficiency, >gr. 2
  • Pacemaker
  • Earlier coronary intervention and not complete revascularization

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interval training

Control

Arm Description

Interval training

Live as usual

Outcomes

Primary Outcome Measures

Change in burden of atrial fibrillation
Burden of atrial fibrillation(number of episodes, duration(percent of the day)) continually measured, and reported by the patient. Analysed for the patients in total, with sub analysis in the groups of paroxysmal and persistent AF and in those with a low burden of atrial fibrillation vs. those with a larger burden.

Secondary Outcome Measures

Size of left atrium and ventricle
Atrial and ventricular size will be evaluated by echocardiography and MRI.
Blood samples
Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.
Endothelial function
FMD
Atrial extrasystoles
Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training.
Ablation procedure
Duration of ablation, number of ablation points, success.
Maximal oxygen uptake
Atrial and ventricular function
Atrial and ventricular function measured by MR and echocardiography
Fibrosis
Fibrosis in left atrium and left ventricle measured by MRI.
Quality of life
Measured with SF-36, Symptom and Severity Checklist and EHRA score of AF- related symptoms
Burden of atrial fibrillation in the intervention period
The intervention period is divided into 3 periods of 4 weeks each. The mean burden of atrial fibrillation(percent of time with atrial fibrillation) and number of episodes in each of those periods will be assessed to see if exercise changes the amount of fibrillation.

Full Information

First Posted
March 23, 2011
Last Updated
January 7, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT01325675
Brief Title
Aerobic Interval Training in Patients With Atrial Fibrillation
Official Title
Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of aerobic interval training in patients with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial fibrillation and symptoms are reduced.
Detailed Description
Long term endurance sport practice is associated with a higher incidence of atrial fibrillation. Moderate/light physical activity seems to be associated with a lower incidence. The underlying mechanisms are uncertain. In order to examine the effect of training in this population, the investigators will perform a randomised controlled study with aerobic interval training in patients with paroxysmal/persistent atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Motor activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interval training
Arm Type
Experimental
Arm Description
Interval training
Arm Title
Control
Arm Type
No Intervention
Arm Description
Live as usual
Intervention Type
Behavioral
Intervention Name(s)
Interval training
Intervention Description
Aerobic interval training will be performed with 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 12 weeks.
Primary Outcome Measure Information:
Title
Change in burden of atrial fibrillation
Description
Burden of atrial fibrillation(number of episodes, duration(percent of the day)) continually measured, and reported by the patient. Analysed for the patients in total, with sub analysis in the groups of paroxysmal and persistent AF and in those with a low burden of atrial fibrillation vs. those with a larger burden.
Time Frame
Baseline and 4 weeks after ended intervention period
Secondary Outcome Measure Information:
Title
Size of left atrium and ventricle
Description
Atrial and ventricular size will be evaluated by echocardiography and MRI.
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Blood samples
Description
Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Endothelial function
Description
FMD
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Atrial extrasystoles
Description
Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training.
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Ablation procedure
Description
Duration of ablation, number of ablation points, success.
Time Frame
Measured during the ablation procedure (day 1)
Title
Maximal oxygen uptake
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Atrial and ventricular function
Description
Atrial and ventricular function measured by MR and echocardiography
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Fibrosis
Description
Fibrosis in left atrium and left ventricle measured by MRI.
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Quality of life
Description
Measured with SF-36, Symptom and Severity Checklist and EHRA score of AF- related symptoms
Time Frame
Baseline and after ended intervention period(12 weeks)
Title
Burden of atrial fibrillation in the intervention period
Description
The intervention period is divided into 3 periods of 4 weeks each. The mean burden of atrial fibrillation(percent of time with atrial fibrillation) and number of episodes in each of those periods will be assessed to see if exercise changes the amount of fibrillation.
Time Frame
Week 1-4, 5-8 and 9-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training. Exclusion Criteria: Performing high intensity training (pulse >90% of max) for more than 2 times a week. Moderate intensity training more than 30 min, more than 3 times a week Previous open heart surgery EF <40% Significant aorta stenosis Mitral insufficiency, >gr. 2 Pacemaker Earlier coronary intervention and not complete revascularization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Paal Loennechen, PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26733609
Citation
Malmo V, Nes BM, Amundsen BH, Tjonna AE, Stoylen A, Rossvoll O, Wisloff U, Loennechen JP. Aerobic Interval Training Reduces the Burden of Atrial Fibrillation in the Short Term: A Randomized Trial. Circulation. 2016 Feb 2;133(5):466-73. doi: 10.1161/CIRCULATIONAHA.115.018220. Epub 2016 Jan 5.
Results Reference
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Aerobic Interval Training in Patients With Atrial Fibrillation

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