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Effects of Detraining in Endurance Athletes With Atrial Fibrillation

NCT ID: NCT04991337

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2024-01-01

Brief Summary

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Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be randomized to an intervention group that will be instructed to refrain from high intensity exercise, and a control group. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients.

Detailed Description

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Atrial fibrillation (AF) affects more than 43 million people worldwide, but specific exercise recommendations do not exist for this group of patients. Despite a lack of evidence, athletes are often advised to reduce exercise intensity (detraining) after being diagnosed with AF. This randomized controlled trial will be the first study that investigates effects of detraining in endurance athletes. Participants will be included at Bærum Hospital, St.Olavs Hospital, Trondheim, Baker Institute, Melbourne, Leuven University Hospital, Antwerp University Hospital, AZ Jan Palfijn Gent and Jessa Hospital Hasselt, Belgium. In total 120 participants will be monitored with a chest-strap heart rate (HR) monitor and sportswatch (exercise intensity), and an Insertable Cardiac Monitor (ICM, AF burden). Participants will be randomized to an intervention group (n=60) that will be instructed to refrain from high intensity exercise (H) \>75% of maximal HR (HRmax)) for a period of 16 Weeks, or a control group (n=60) that will be instructed to perform at least three weekly sessions of high intensity training (HR ≥85% of HRmax. The primary endpoint will be AF burden, as measured by continuous monitoring with ICMs and calculated as the cumulative duration of all AF episodes lasting ≥30sec divided by total duration of monitoring. The study aims to clarify whether detraining might reduce the burden of AF and has the potential to guide development of exercise guidelines for AF patients. The investigators will also study exercise-induced cardiac remodeling, aiming to improve the understanding of underlying pathophysiological mechanisms for AF.

Conditions

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Atrial Fibrillation

Keywords

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heart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm international multicenter open-label randomized (1:1) controlled trial with blinded end-point evaluation.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Open label study and participants are not blinded to group allocation. Researchers and staff are unblinded during all procedures. AF burden will be adjudicated by a blinded endpoint committee and researchers will be blinded to group allocation when performing statistical analyses.

Study Groups

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Detraining group

Will be instructed to avoid high-intensity exercise corresponding to a heart rate \>75% of maximum heart rate, and a total duration of exercise (hours/week) corresponding to \>80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 week.

Group Type EXPERIMENTAL

Detraining group

Intervention Type BEHAVIORAL

Detraining is defined as exercise corresponding to a heart rate ≤75% of maximum heart rate and ≤80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 weeks.

Control group

Will be instructed to perform at least three weekly sessions of high intensity exercise, corresponding to a HR ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual.

Group Type EXPERIMENTAL

Control group

Intervention Type BEHAVIORAL

At least three weekly sessions of high intensity exercise, corresponding to a heart rate ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual.

Interventions

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Detraining group

Detraining is defined as exercise corresponding to a heart rate ≤75% of maximum heart rate and ≤80% of the self-reported average weekly amount of exercise (hours/week) during the past six months, for a period of 16 weeks.

Intervention Type BEHAVIORAL

Control group

At least three weekly sessions of high intensity exercise, corresponding to a heart rate ≥85% of maximum heart rate, and otherwise continue endurance exercise as usual.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Age ≥ 18 years
* Diagnosed with paroxysmal atrial fibrillation (verified by electrocardiogram)
* Report \>5 (running, rowing) or \>8 (cycling, cross-country skiing), weekly hours, respectively, of endurance sport
* At least two anamnestic (self-reported) episodes of atrial fibrillation, of which one during the last six months
* Use a smartphone and agree to connect their sportswatch with a web-based platform for monitoring of exercise

Exclusion Criteria

* Permanent atrial fibrillation
* Cardiac conditions (including valvular heart disease of moderate or greater severity, symptomatic ischemic heart disease)
* Left ventricular ejection fraction \<45%
* Hypertension (\>140/90)
* Diabetes mellitus
* Hyperthyroidism
* Smoking during the last 5 years
* Alcohol intake \>20 alcohol units/week
* Use of illegal or performance enhancing drugs
* Body mass index \>30kg/m2
* Injuries preventing physical exercise
* Pregnancy
* Participation in conflicting intervention research studies
* Planned atrial fibrillation ablation within the next six months
* The individual refuses to have an insertable cardiac monitor, blood samples taken or be part of the detraining group
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Baker Heart and Diabetes Institute

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marius Myrstad, |MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken Health trust

Locations

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Vestre Viken Health Trust, Baerum Hospital

Bærums verk, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Marius Myrstad, MD;PhD

Role: CONTACT

Phone: +47 92255945

Email: [email protected]

Marius Myrstad, MD, PhD

Role: CONTACT

Phone: +47 92255945

Email: [email protected]

Facility Contacts

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Marius Myrstad, MD, PhD

Role: primary

References

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Apelland T, Letnes JM, Janssens K, Claessen G, Tveit A, Sellevold AB, Mitchell A, Willems R, Onarheim S, Enger S, Kizilkilic SE, Miljoen H, Elliott A, Loennechen JP, La Gerche A, Myrstad M; NEXAF Investigators. Arrhythmia burden, symptoms and quality of life in female and male endurance athletes with paroxysmal atrial fibrillation: a multicentre cohort study in Norway, Australia and Belgium. BMJ Open. 2025 Aug 5;15(8):e100496. doi: 10.1136/bmjopen-2025-100496.

Reference Type DERIVED
PMID: 40764068 (View on PubMed)

Apelland T, Sellevold AB, Letnes JM, Onarheim S, Enger S, Tveit A, Delpire B, Claessen G, La Gerche A, Loennechen JP, Berge T, Myrstad M; NEXAF Investigators; NEXAF investigators. Cardiac arrhythmia assessment with patch electrocardiogram versus insertable cardiac monitor: a cohort study in endurance athletes with atrial fibrillation. BMJ Open. 2025 Jan 6;15(1):e093250. doi: 10.1136/bmjopen-2024-093250.

Reference Type DERIVED
PMID: 39762092 (View on PubMed)

Apelland T, Janssens K, Loennechen JP, Claessen G, Sorensen E, Mitchell A, Sellevold AB, Enger S, Onarheim S, Letnes JM, Miljoen H, Tveit A, La Gerche A, Myrstad M; NEXAF investigators. Effects of training adaption in endurance athletes with atrial fibrillation: protocol for a multicentre randomised controlled trial. BMJ Open Sport Exerc Med. 2023 Apr 11;9(2):e001541. doi: 10.1136/bmjsem-2023-001541. eCollection 2023.

Reference Type DERIVED
PMID: 37073174 (View on PubMed)

Other Identifiers

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NEXAF Detraining

Identifier Type: -

Identifier Source: org_study_id