The Norwegian Exercise in Atrial Fibrillation Trial
- Conditions
- Atrial Fibrillation
- Interventions
- Behavioral: Supervised home-based exerciseOther: Usual care
- Registration Number
- NCT05164718
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Supervised home-based exercise - Control group Usual care -
- Primary Outcome Measures
Name Time Method Total time-in-AF(%) 12 months Measured by implantable loop recorder over 12 months
Change in health-related quality of life and symptoms 12 months 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.
- Secondary Outcome Measures
Name Time Method Frequency and duration of AF episodes 12 months 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.
Frequency and severity of atrial fibrillation symptoms 6 and 12 months 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.
Change in peak oxygen uptake (VO2peak) 12 months Measured by ergospirometry pre- and post-intervention
Change in physical and mental dimensions of health 6 months and 12 months 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".
Change in cardiovascular risk factors 12 months Sum of z-scores of waist, blood pressure, HDL-cholesterol, triglycerides and glucose.
Changes in cardiac volume and dimensions 12 months 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
Incident mortality, cardiovascular events, cardioversions, ablations and total hospitalization 12 months Information about hospitalizations and the discharge diagnoses will be collected by journal review
Safety outcome parameters 12 months Death or unplanned hospitalization summarized per treatment group.
Physical activity level and adherence 6 and 12 months. 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).
Trial Locations
- Locations (3)
Vestre Viken HF
🇳🇴Drammen, Norway
University Hospital of North Norway
🇳🇴Tromsø, Norway
St Olavs Hospital
🇳🇴Trondheim, Norway
Vestre Viken HF🇳🇴Drammen, Norway