The Norwegian Exercise in Atrial Fibrillation Trial

NCT05164718 | Active Not Recruiting

• 4 other identifiers: 2138489053830031557822568
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

Exercise therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• Total time-in-AF(%)

  Measured by implantable loop recorder over 12 months

  12 months

Secondary Outcomes (9)

• Frequency and duration of AF episodes

  12 months

• Frequency and severity of atrial fibrillation symptoms

  6 and 12 months

• Change in peak oxygen uptake (VO2peak)

  12 months

• Change in physical and mental dimensions of health

  6 months and 12 months

• Change in cardiovascular risk factors

  12 months

Other Outcomes (10)

• Other changes in cardiac structure and function

  12 months

• Change in blood pressure

  12 months

• Change in lipids

  12 months

Study Arms (2)

Exercise group

EXPERIMENTAL

Behavioral: Supervised home-based exercise

Control group

OTHER

Other: Usual care

Interventions

Supervised home-based exercise 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.

Exercise group

Usual care 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.

Control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• UiT The Arctic University of Norway: collaborator
• University Hospital of North Norway: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (3)

Vestre Viken HF

Drammen, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 40122568 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Øystein Risa

  NTNU, Department of Circulation and Medical Imaging

  STUDY DIRECTOR

• Rune Wiseth, md phd

  St Olavs Hospital, Clinic of Cardiology

  STUDY DIRECTOR

• Bjarne M Ness, phd

  NTNU, Department of Circulation and Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants are not blinded to group allocation. Researchers will be blinded to group allocation when performing statistical analyses. At study completion, a de-identified copy of the data will be extracted for statistical analyses. Information on group allocation will be kept at the Clinical research Unit in Mid-Norway and provided to the research team once a blinded interpretation of the results is finalized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 21, 2021
• Study Start: February 4, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

NO (3)