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Atrial FibrillationNEXAFNCT05164718

The Norwegian Exercise in Atrial Fibrillation Trial

A study testing Supervised home-based exercise in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atrial fibrillation (AF) patients suffer a high symptom burden and reduced quality of life (QoL), high hospitalization rates and few effective treatment options. They have a high burden of cardiovascular risk factors and events. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Supervised home-based exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesNorway
Study dates
4 Feb 2022to 17 Sep 2025
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Diagnosed with paroxysmal or persistent AF in hospital registries
  • In sinus rhythm at baseline screening
  • Report <75 minutes per week of vigorous and/or <150 minutes of moderate intensity exercise the last three months
  • Use a smartphone

Who cannot join

  • Permanent AF or persistent AF with at least one continuous episode lasting ≥3 months the last year
  • AF as a complication of acute coronary syndromes, cardiothoracic surgery or infections
  • Planned ablation procedure next 12 months or ablated last 6 months without known recurrence
  • Unstable coronary heart disease
  • De-compensated heart failure
  • Left ventricular ejection fraction <40%
Show all 16Show fewer
  • At least moderate to severe mitral or aortic pathology, or aortic aneurysms clinically incompatible with safe exercise
  • Moderate to severe chronic obstructive pulmonary disease (GOLD group C+D)
  • Ongoing severe cancer or active cancer treatment
  • Pacemaker or ICD
  • Pregnancy
  • Alcohol or drug abuse
  • Cognitive or serious psychiatric disease that may impede protocol compliance
  • Physical impairments or diseases hindering exercise or making exercise contraindicated
  • Resident of nursing home or other institution
  • Participation in conflicting research studies (i.e. lifestyle interventions)

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Vestre Viken HF

    Drammen

  • University Hospital of North Norway

    Tromsø

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

Official title: The Norwegian Exercise in Atrial Fibrillation Trial - An Open-label, Multicenter Randomized Controlled Trial Comparing an eHealth-based Exercise Intervention With Usual Care After 12 Months Follow-up

Atrial fibrillation (AF) patients suffer a high symptom burden and reduced quality of life (QoL), high hospitalization rates and few effective treatment options. They have a high burden of cardiovascular risk factors and events. Lifestyle changes and exercise is a cornerstone of management in most chronic cardiac conditions and holds promise in AF, but the evidence is sparse and specific guidelines for exercise do not exist for AF patients. NEXAF is a large-scale multicenter randomized trial to determine the feasibility and effects of exercise on patient-reported and clinical outcomes. All patients will undergo continuous rhythm monitoring, enabling assessment of duration, frequency and total time of AF episodes. The overall aim of the study is to provide documentation for clinical exercise recommendations in AF. The objectives are to examine the effects of a 1-year exercise intervention in AF patients on (i) QoL and symptom burden, (ii) time-in-AF, and peak oxygen uptake, cardiac structure and function, cardiovascular risk factors and use of healthcare resources.

Read the detailed description

A pre-planned substudy will examine the immediate (24-h to 7 days) effects of vigorous exercise on AF-burden in a subgroup of participants from each arm. Two main outcomes are prespecified: (i) mean time-in-AF measured by an insertable cardiac monitor (ICM) 24 hours after maximal exercise testing at baseline and follow-up compared to mean of the last week before exercise test. (ii) Normal cardiac biomarker response for Troponin and NT-proBNP to acute exercise (0h, 3h, 24h post exercise). Secondary outcomes are mean time-in-AF the consecutive week and post-exercise heart rate variability and number of atrial and ventricular extra systoles at the same time points. Further, changes in post-exercise responses after the intervention (12 months) and the effect on clinical outcomes will be examined.

Being tested
Supervised home-based exercise, Usual care
Keywords
Exercise therapy
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised home-based exerciseBehavioural

    150-300 minutes of moderate intensity activity (55-75% of maximum heart rate in sinus rhythm or RPE 12-13 on the Borg Scale) or 75-150 minutes of vigorous intensity activity (75-90% of maximum heart rate or 14-16 on the Borg Scale) per week, or an equivalent combination of both, according to current general recommendations, including also those with established CVD. To maximize the potential for improvements in cardiorespiratory fitness, we encourage that at least 40-60 minutes per week (i.e. 2 sessions á 20-30 minutes) should be of vigorous intensity.

  • Usual careOther

    Standard management according to usual practice at the respective participating centers, including medical therapy as per guidelines. Prior to randomization all will be provided an ICM (Confirm RX™). The UC group will receive information about general PA recommendations as per guidelines at study enrollment. No further supervision is given.

Study groups in NCT05164718
Study groupRoleWhat they receive
Exercise groupExperimentalNot described
Receives: Behavioral: Supervised home-based exercise
Control groupOtherNot described
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in health-related quality of life and symptoms

    Overall score (0-100) of the 20-item Atrial Fibrillation Effect and Quality of Life (AFEQT) questionnaire. The subscale scores on symptoms, daily activities, and treatment concern, respectively, and the overall score at 6 months, will aid to interpretation as secondary endpoints. Two questions regarding satisfaction with health care providers and treatment are not included in the overall score and will not be collected.

    Measured: 12 months

  2. Total time-in-AF(%)

    Measured by implantable loop recorder over 12 months

    Measured: 12 months

Secondary outcomes (9)

  1. Frequency and duration of AF episodes

    Number of recorded AF episodes during follow-up will be calculated from the continuous ILR measurement over the 12 months. We will analyze between group differences (exercise vs. conventional management) in number of continuous AF episodes ≥6min, ≥60min, ≥24h and ≥7 days, respectively, as well as differences in median episode duration.

    Measured: 12 months

  2. Frequency and severity of atrial fibrillation symptoms

    Measured by the 16-item AF symptoms and severity checklist. Total score on frequency and severity, respectively, and a subscore of AF-specific symptoms will be analyzed.

    Measured: 6 and 12 months

  3. Change in peak oxygen uptake (VO2peak)

    Measured by ergospirometry pre- and post-intervention

    Measured: 12 months

  4. Change in physical and mental dimensions of health

    The 12 item RAND-12 questionnaire corresponding to eight principal physical and mental health domains. Summarized into two scores; "Physical Health Summary Measure (PCS-physical component score)" and "Mental Health Summary Measure (MCS-mental component score). The EQ-VAS score will ask the patients to simply rate their current health status on a 0-100 scale ranging from "the best health you can imagine" to "the worst health you can imagine".

    Measured: 6 months and 12 months

  5. Change in cardiovascular risk factors

    Sum of z-scores of waist, blood pressure, HDL-cholesterol, triglycerides and glucose.

    Measured: 12 months

  6. Changes in cardiac volume and dimensions

    Echocardiographic indices of left atrial end-systolic volume (crude and indexed to body surface area), left ventricular end-diastolic volume and left atrial end-systolic to left ventricular end-diastolic volume ratio

    Measured: 12 months

  7. Incident mortality, cardiovascular events, cardioversions, ablations and total hospitalization

    Information about hospitalizations and the discharge diagnoses will be collected by journal review

    Measured: 12 months

  8. Safety outcome parameters

    Death or unplanned hospitalization summarized per treatment group.

    Measured: 12 months

  9. Physical activity level and adherence

    Self-reported physical activity (PA) will be measured by questionnaire consisting of 3 items (frequency, duration and intensity of regular exercise) in both groups at baseline, 6- and 12 months. Responses of frequency (exercise sessions per week) will be combined with duration of exercise (minutes per session) to estimate weekly minutes of exercise. Minutes of exercise will then be combined with reported intensity (light, moderate, vigorous) to calculate exercise volume and evaluate adherence to the intervention (numbers above and below recommended volume).

    Measured: 6 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start4 Feb 2022
  3. Primary completion4 Jul 2025
  4. Study completion17 Sep 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164718
Sponsor's protocol ID
213848
Other IDs
90538300, 315578, 22568
Acronym
NEXAF
Status last verified
Jul 2026
First submitted
18 Nov 2021
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nes BM, Letnes JM, Johnson KE, Sellevold AB, Byrkjeland R, Brown FP, Follestad T, Dalen H, Wisloff U, Lochen ML, Tveit A, Morseth B, Myrstad M, Loennechen JP; NEXAF consortium; The NEXAF consortium. Effects of 1-year exercise in patients with atrial fibrillation: study protocol for the Norwegian Exercise in Atrial Fibrillation (NEXAF) randomised controlled trial. Open Heart. 2025 Mar 22;12(1):e003077. doi: 10.1136/openhrt-2024-003077.

    PubMed 40122568

Questions about this trial

What is this clinical trial studying?

A study testing Supervised home-based exercise in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 3 sites 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 5 inclusion and 16 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 health-related quality of life and symptoms (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05164718, 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 Jul 2026.

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