The Norwegian Exercise in Atrial Fibrillation Trial

NCT ID: NCT05164718

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2025-12-31

Brief 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. 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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise group

Group Type: EXPERIMENTAL

Supervised home-based exercise

Intervention Type: BEHAVIORAL

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.

Control group

Group Type: OTHER

Usual care

Intervention Type: OTHER

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.

Interventions

Supervised home-based exercise

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.

Intervention Type: BEHAVIORAL

Usual care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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%
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øystein Risa

Role: STUDY_DIRECTOR

NTNU, Department of Circulation and Medical Imaging

Rune Wiseth, md phd

Role: STUDY_DIRECTOR

St Olavs Hospital, Clinic of Cardiology

Bjarne M Ness, phd

Role: PRINCIPAL_INVESTIGATOR

NTNU, Department of Circulation and Imaging

Locations

Vestre Viken HF

Drammen, , Norway

University Hospital of North Norway

Tromsø, , Norway

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40122568 (View on PubMed)

Other Identifiers

90538300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

315578

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22568

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

213848

Identifier Type: -

Identifier Source: org_study_id