Clinical trial NCT05164718: The Norwegian Exercise in Atrial Fibrillation Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: UiT The Arctic University of Norway
name: University Hospital of North Norway
name: Vestre Viken Hospital Trust
First posted: 2021-12-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in health-related quality of life and symptoms
timeFrame: 12 months
measure: Total time-in-AF(%)
timeFrame: 12 months
Secondary outcomes:
measure: Frequency and duration of AF episodes
timeFrame: 12 months
measure: Frequency and severity of atrial fibrillation symptoms
timeFrame: 6 and 12 months
measure: Change in peak oxygen uptake (VO2peak)
timeFrame: 12 months
measure: Change in physical and mental dimensions of health
timeFrame: 6 months and 12 months
measure: Change in cardiovascular risk factors
timeFrame: 12 months
measure: Changes in cardiac volume and dimensions
timeFrame: 12 months
measure: Incident mortality, cardiovascular events, cardioversions, ablations and total hospitalization
timeFrame: 12 months
measure: Safety outcome parameters
timeFrame: 12 months
measure: Physical activity level and adherence
timeFrame: 6 and 12 months.
Other outcomes:
measure: Other changes in cardiac structure and function
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: 12 months
measure: Change in lipids
timeFrame: 12 months
measure: Change in body weight
timeFrame: 12 months
measure: Acute biomarker response to high-intensity exercise
timeFrame: 0, 3 and 24 hours, respectively, after maximal exercise test compared to resting values at baseline and 12 months follow-up
measure: Cognitive function parameters
timeFrame: 12 months
measure: Usability
timeFrame: 12 months
measure: Immediate effects of vigorous exercise on time-in-atrial fibrillation
timeFrame: 0-7 days (daily and cumulative) after maximal test pre- and post-intervention
measure: Perceived competence for exercise
timeFrame: 12 months
measure: Self-efficacy for exercise
timeFrame: 12 months
Locations:
city: Drammen
country: Norway
facility: Vestre Viken HF
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: NTNU, Department of Circulation and Medical Imaging
name: Øystein Risa
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Clinic of Cardiology
name: Rune Wiseth, md phd
role: STUDY_DIRECTOR
affiliation: NTNU, Department of Circulation and Imaging
name: Bjarne M Ness, phd
role: PRINCIPAL_INVESTIGATOR
References: