Effects of Detraining in Endurance Athletes With Atrial Fibrillation

NCT04991337 | Unknown

• 1 other identifier: NEXAF Detraining
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

heart

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation burden

  Atrial fibrillation burden (time with atrial fibrillation) as measured by continuous monitoring with insertable cardiac monitor and calculated as the cumulative duration of all atrial fibrillation episodes lasting ≥30sec divided by total duration of monitoring and reported as percentages.

  Measured during the last 4 weeks (week 13-16) of the 16-week intervention period

Secondary Outcomes (38)

• Atrial fibrillation burden

  Measured during the first 4 weeks (week 1-4) of the 16-week intervention period

• Atrial fibrillation burden

  Measured during week 5-8 of the 16-week intervention period

• Atrial fibrillation burden

  Measured during week 9-12 of the 16-week intervention period

• Cumulative atrial fibrillation burden

  Measured during the entire 16-week intervention period

• Atrial fibrillation episode duration

  Measured during the 16-week intervention period

Study Arms (2)

Detraining group

EXPERIMENTAL

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.

Behavioral: Detraining group

Control group

EXPERIMENTAL

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.

Behavioral: Control group

Interventions

Detraining group 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.

Detraining group

Control group 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.

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• St. Olavs Hospital: collaborator
• Baker Heart and Diabetes Institute: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Hospital, Antwerp: collaborator
• AZ Jan Palfijn Gent: collaborator
• Jessa Hospital: collaborator

Study Sites (1)

Vestre Viken Health Trust, Baerum Hospital

Bærums verk, Norway

RECRUITING

Related Publications (3)

• 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.

  PMID: 40764068 DERIVED

• 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.

  PMID: 39762092 DERIVED

• 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.

  PMID: 37073174 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marius Myrstad, |MD, PhD

  Vestre Viken Health trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Myrstad, MD;PhD

CONTACT

+47 92255945; marium@vestreviken.no

Marius Myrstad, MD, PhD

CONTACT

+47 92255945; marium@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: August 5, 2021
• Study Start: January 5, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)