Atrial FibrillationNCT01325675
Aerobic Interval Training in Patients With Atrial Fibrillation
A study testing Interval training in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology
Trondheim, Trondheim, 7491
About this study
Official title: Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Interval training
- Keywords
- Atrial fibrillation, Motor activity
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interval training | Experimental | Interval training Receives: Behavioral: Interval training |
| Control | No intervention | Live as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks after ended intervention period
Secondary outcomes (10)
Size of left atrium and ventricle
Atrial and ventricular size will be evaluated by echocardiography and MRI.
Measured: Baseline and after ended intervention period(12 weeks)
Blood samples
Interleukin-6, pro-BNP, d-dimer and von Willenbrands factor are measured.
Measured: Baseline and after ended intervention period(12 weeks)
Endothelial function
FMD
Measured: Baseline and after ended intervention period(12 weeks)
Atrial extrasystoles
Atrial extrasystoles on 48h Holter monitoring. Will alse be measured in the first week of training.
Measured: Baseline and after ended intervention period(12 weeks)
Ablation procedure
Duration of ablation, number of ablation points, success.
Measured: Measured during the ablation procedure (day 1)
Maximal oxygen uptake
Measured: Baseline and after ended intervention period(12 weeks)
Atrial and ventricular function
Atrial and ventricular function measured by MR and echocardiography
Measured: Baseline and after ended intervention period(12 weeks)
Fibrosis
Fibrosis in left atrium and left ventricle measured by MRI.
Measured: Baseline and after ended intervention period(12 weeks)
Quality of life
Measured with SF-36, Symptom and Severity Checklist and EHRA score of AF- related symptoms
Measured: Baseline and after ended intervention period(12 weeks)
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.
Measured: Week 1-4, 5-8 and 9-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Jan Paal Loennechen, PhD, Study chair, St. Olavs HospitalUlrik Wisløff, PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325675
- Sponsor's protocol ID
- 2010/3345-1(REK)
- Status last verified
- Jan 2016
- First submitted
- 23 Mar 2011
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26733609
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Interval Training in Patients With Paroxysmal or Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01325675
- Acronym / sponsor ID
- 2010/3345-1(REK)
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Motor activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, SINTEF Health Research
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval training | Experimental | Behavioral: Interval trainingInterval training |
| Control | No intervention | –Live as usual |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with paroxysmal or persistent atrial fibrillation, that are able to perform aerobic interval training.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval trainingAerobic 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. | Behavioural | Interval training |
Primary outcome
Change in burden of atrial fibrillation
Time frame: Baseline and 4 weeks after ended intervention period
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.
10 secondary outcomes
Size of left atrium and ventricle
Time frame: Baseline and after ended intervention period(12 weeks)
Blood samples
Time frame: Baseline and after ended intervention period(12 weeks)
Endothelial function
Time frame: Baseline and after ended intervention period(12 weeks)
Atrial extrasystoles
Time frame: Baseline and after ended intervention period(12 weeks)
Ablation procedure
Time frame: Measured during the ablation procedure (day 1)
Maximal oxygen uptake
Time frame: Baseline and after ended intervention period(12 weeks)
Atrial and ventricular function
Time frame: Baseline and after ended intervention period(12 weeks)
Fibrosis
Time frame: Baseline and after ended intervention period(12 weeks)
Quality of life
Time frame: Baseline and after ended intervention period(12 weeks)
Burden of atrial fibrillation in the intervention period
Time frame: Week 1-4, 5-8 and 9-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Results publication: PubMed 26733609Malmo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Paal Loennechen, PhD study chair
St. Olavs Hospital
Ulrik Wisløff, PhD study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval training in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in burden of atrial fibrillation (time frame: Baseline and 4 weeks after ended intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01325675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.