The Norwegian Exercise in Atrial Fibrillation Trial (NEXAF)

Norwegian University of Science and Technology

Status

Active, not recruiting

Conditions

Atrial Fibrillation

Treatments

Behavioral: Supervised home-based exercise

Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT05164718

213848

90538300 (Other Grant/Funding Number)

22568 (Other Grant/Funding Number)

315578 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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)