NCT01325675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

March 23, 2011

Last Update Submit

January 7, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationMotor activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 4 weeks after ended intervention period

Secondary Outcomes (10)

  • Size of left atrium and ventricle

    Baseline and after ended intervention period(12 weeks)

  • Blood samples

    Baseline and after ended intervention period(12 weeks)

  • Endothelial function

    Baseline and after ended intervention period(12 weeks)

  • Atrial extrasystoles

    Baseline and after ended intervention period(12 weeks)

  • Ablation procedure

    Measured during the ablation procedure (day 1)

  • +5 more secondary outcomes

Study Arms (2)

Interval training

EXPERIMENTAL

Interval training

Behavioral: Interval training

Control

NO INTERVENTION

Live as usual

Interventions

Interval trainingBEHAVIORAL

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.

Interval training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Trondheim, 7491, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26733609RESULT

MeSH Terms

Conditions

Atrial FibrillationMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jan Paal Loennechen, PhD

    St. Olavs Hospital

    STUDY CHAIR

  • Ulrik Wisløff, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 30, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

NO(1)