Effects of Detraining in Endurance Athletes With Atrial Fibrillation (NEXAF)

December 20, 2022 updated by: Vestre Viken Hospital Trust

Effects of Detraining in Endurance Athletes With Atrial Fibrillation (NEXAF Detraining)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Bærums Verk, Norway
        • Recruiting
        • Vestre Viken Health Trust, Baerum Hospital
        • Contact:
          • Marius Myrstad, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atrial fibrillation burden
Time Frame: Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atrial fibrillation burden
Time Frame: Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Atrial fibrillation burden 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.
Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Atrial fibrillation burden
Time Frame: Measured during week 5-8 of the 16-week intervention period
Atrial fibrillation burden 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.
Measured during week 5-8 of the 16-week intervention period
Atrial fibrillation burden
Time Frame: Measured during week 9-12 of the 16-week intervention period
Atrial fibrillation burden 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.
Measured during week 9-12 of the 16-week intervention period
Cumulative atrial fibrillation burden
Time Frame: Measured during the entire 16-week intervention period
Atrial fibrillation burden 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.
Measured during the entire 16-week intervention period
Atrial fibrillation episode duration
Time Frame: Measured during the 16-week intervention period
Mean duration of atrial fibrillation episodes lasting ≥30sec
Measured during the 16-week intervention period
Atrial fibrillation episodes
Time Frame: Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Measured during the first 4 weeks (week 1-4) of the 16-week intervention period
Atrial fibrillation episodes
Time Frame: Measured during week 5-8 of the 16-week intervention period
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Measured during week 5-8 of the 16-week intervention period
Atrial fibrillation episodes
Time Frame: Measured during week 9-12 of the 16-week intervention period
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Measured during week 9-12 of the 16-week intervention period
Atrial fibrillation episodes
Time Frame: Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Measured during the last 4 weeks (week 13-16) of the 16-week intervention period
Cumulative atrial fibrillation episodes
Time Frame: Measured during the 16-week intervention period
Number of atrial fibrillation episodes lasting ≥30sec, as measured by insertable cardiac monitor
Measured during the 16-week intervention period
Days with atrial fibrillation
Time Frame: Measured during the 16-week intervention period
Days with at least one episode of atrial fibrillation lasting ≥30sec
Measured during the 16-week intervention period
Days without atrial fibrillation
Time Frame: Measured during the 16-week intervention period
Days without atrial fibrillation episodes
Measured during the 16-week intervention period
Relative change in atrial fibrillation burden
Time Frame: Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period
Relative change in atrial fibrillation burden 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
Measured during the 4-week baseline period prior to randomization and during the last 4 weeks of the 16-week intervention period
Relative change in atrial fibrillation burden
Time Frame: Measured during the 4-week baseline period prior to randomization and during the first 4 weeks of the 16-week intervention period
Relative change in atrial fibrillation burden 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
Measured during the 4-week baseline period prior to randomization and during the first 4 weeks of the 16-week intervention period
Relative change in atrial fibrillation burden
Time Frame: Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period
Relative change in atrial fibrillation burden 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
Measured during the 4-week baseline period prior to randomization and during the entire 16-week intervention period
Adherence to prescribed exercise
Time Frame: 16 weeks
Adherence to prescribed exercise (>80% of exercise with ≥85% and ≤75% of maximum heart rate, respectively)
16 weeks
Exercise capacity
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Peak oxygen uptake (VO2peak)
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Atrial volumes
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Right and left atrial volumes measured with echocardiography
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Ventricular volumes
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Right and left ventricular volumes measured with echocardiography
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Atrial function
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Left atrial function measured by strain with echocardiography
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Ventricular function
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Right and left ventricular function measured by strain with echocardiography
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Systolic function
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Left ventricular ejection fraction measured by strain with echocardiography
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Atrial fibrillation symptoms
Time Frame: Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period
Self-reported number of symptomatic atrial fibrillation episodes
Measured by questtionnaire at the baseline study visit and at the final study visit after the 16-week intervention period
Atrial Fibrillation Effect on QualiTy-of-life questionnaire
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period

Measured with the Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT).

Minimum score 0, maximum score 100, higher values indicate better quality of life
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Atrial fibrillation hospitalizations
Time Frame: Throughout study completion, an average of 22 weeks
Number of unplanned hospitalizations due to atrial fibrillation cardioversion or ablation
Throughout study completion, an average of 22 weeks
Modified European Heart Rhythm Association Symptom Scale (mEHRA) symptom classification
Time Frame: Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Modified European Heart Rhythm Association Symptom Scale (mEHRA) questionnaire. The scale ranges from minimum 1 to maxiumum 4, a higher score indicates a worse symptom burden
Measured at the baseline study visit and at the final study visit after the 16-week intervention period
Number of ventricular arrhythmias
Time Frame: Throughout study completion, an average of 22 weeks
Ventricular arrhythmias lasting ≥12 ventricular complexes as measured by continuous monitoring with insertable cardiac monitor
Throughout study completion, an average of 22 weeks
Number of adverse events
Time Frame: Throughout study completion, an average of 22 weeks
Any unfavorable and unintended sign, symptom or illness that develops or worsens during the trial period will be reported as adverse events (AE). A serious adverse event (SAE) is defined as death, any life-threatening event or any inpatient hospitalisation
Throughout study completion, an average of 22 weeks
Cardiovascular risk factors measured by blood pressure
Time Frame: Measured at baseline and after the 16-week intervention period
Measure of blood pressure (mmHg)
Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by blood lipids
Time Frame: Measured at baseline and after the 16-week intervention period
Blood lipids (mmol/L)
Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by weight
Time Frame: Measured at baseline and after the 16-week intervention period
Weight (kg)
Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by BMI
Time Frame: Measured at baseline and after the 16-week intervention period
BMI (weight and height will be combined to report BMI in kg/m^2)
Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by smoking
Time Frame: Measured at baseline and after the 16-week intervention period
Smoking (pack years)
Measured at baseline and after the 16-week intervention period
Cardiovascular risk factors measured by alcohol units
Time Frame: Measured at baseline and after the 16-week intervention period
Alcohol use (units)
Measured at baseline and after the 16-week intervention period
Cardiovascular biomarkers - inflammation markers
Time Frame: Measured at baseline and after the 16-week intervention period
Markers for inflammation markers; interleukines and hrCRP (mg/L)
Measured at baseline and after the 16-week intervention period
Cardiovascular biomarkers - markers for myocardial damage
Time Frame: Measured at baseline and after the 16-week intervention period
Markers for myocardial damage, measured by troponin T (ng/L) and NT-ProBNP (ng/L)
Measured at baseline and after the 16-week intervention period
Immediate effects on arrhythmia burden of high-intensity exercise
Time Frame: 24 hours after after peak exercise testing
Ahrrythmias measured with 24-hour electrocardiogram after peak exercise testing
24 hours after after peak exercise testing
Immediate effects on biomarkers of exercise
Time Frame: At peak exercise during cardiopulmonary exercise testing
Blood sampling at peak exercise for analyses of cardiac Troponins, NT-pro-BNP, interleukins, C-reactive protein
At peak exercise during cardiopulmonary exercise testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vestre Viken Hospital Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitaire Ziekenhuizen KU Leuven
Jessa Hospital
St. Olavs Hospital
University Hospital, Antwerp
Baker Heart and Diabetes Institute
AZ Jan Palfijn Gent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marius Myrstad, |MD, PhD, Vestre Viken Health Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEXAF Detraining

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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