Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000456651
Ethics application status
Approved
Date submitted
28/02/2023
Date registered
3/05/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
3/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise Training After Atrial Fibrillation Ablation
Scientific title
Randomised, Controlled Trial of Exercise Training versus Standard Medical Care on Atrial Fibrillation Recurrence After Ablation in Patients with Symptomatic Atrial Fibrillation
Secondary ID [1] 309093 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
EXIT-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 329164 0
Condition category
Condition code
Cardiovascular 326136 326136 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 326547 326547 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This progressive exercise interventions builds on successful interventions implemented in different settings by members of the investigator team. Specifically, the intervention includes four phases:

Phase 1 (0-3 wks post-ablation, Recovery) will include a remote education component, delivered using online video consultation, that provides guidance on establishing physical activity following an ablation procedure. During these remote consultations, a clinical exercise physiologist will outline the evidence-base regarding exercise training for AF patients and will discuss potential barriers to exercise with the patient. The forms of exercise that are suitable for patients with AF will be discussed. The preferences of each patient regarding modes of exercise will be evaluated. Supervised visits will commence from 3 weeks post-ablation. It is anticipated that two 30-minute consultations will be provided within this phase of the intervention.

Phase 2 (3-12 wks, Base Training) will target a 10-20% weekly increase in aerobic exercise duration progressing to 210 minutes per week and will include fortnightly supervised visits with an exercise physiologist, with each visit lasting approximately 1 hour. Aerobic exercise will be prescribed within the moderate exercise domain (60-80% heart rate reserve [HRR] or rating of perceived exertion of 6-7 out of 10). Examples of home-based aerobic exercise prescribed within this phase may include outdoor walking, cycling on flat terrain, swimming, dancing or group aerobic exercise. Home-based aerobic exercise will be monitored using a heart rate monitor provided to each patient, and a physical activity diary that can be completed each day. During supervised exercise sessions, participants may be recommended treadmill walking, indoor cycling, rowing, or elliptical exercise, with continuous monitoring using heart rate enabled watches. Attendance at each supervised session will be recorded by study investigators.

Phase 3 (12-26 wks, Adaptation) will progressively initiate aerobic interval training activities up to twice per week using a 4x4-min interval structure with a target intensity of 85-90% HRR for each interval. For participants, this means completing four-minute ‘intervals’ at an intensity that requires heavy breathing and an increase in heart rate up to approximately 90% of its maximum, as determined during baseline testing. Participants will repeat these intervals four times, with a three-minute active recovery between each effort. Active recovery may include slow walking or light cycling. Home-based aerobic interval training may be performed on a grass sports pitch, walking trail or hilly area. Supervised visits will remain on a fortnightly frequency. During supervised visits, aerobic interval exercise will be performed on an indoor bike or treadmill. Through phase 3, the target weekly aerobic exercise duration will remain at 210 minutes of moderate to vigorous activity. Attendance at each supervised session will be recorded by study investigators.


Finally, in Phase 4 (26-52 wks, Maintenance) will focus on maintenance of aerobic exercise habits, whilst ensuring appropriate progression in intensity in proportion to adaptation of individual physical capacity. During phase 4, supervised visits of 45-60 minutes will decrease in frequency to monthly. However, scheduled televisits of 15-30 minutes will be planned with a clinical exercise physiologist during the intervening periods to promote adherence and modify/update exercise prescription where required. Throughout the intervention phase, all home-based aerobic exercise will be recorded using commercially available heart rate monitors and physical activity trackers provided to each patient. Tailored, individualised exercise plans will be provided to each patient after completion of each supervised visit. Adherence to the intervention will be assessed through documented exercise recorded on heart rate monitors and attendance records for supervised visits maintain by study staff.
Intervention code [1] 325538 0
Treatment: Other
Comparator / control treatment
Patients in the control arm (standard medical care only) will continue to receive guideline-directed, standard medical care as per current National Heart Foundation/Cardiac Society of Australia and New Zealand clinical guidelines. Principally, this focusses on three pillars of AF management (rate & rhythm control, anticoagulation). In our centre, this includes nurse and physician-led management of AF risk factors. Within this framework, participants in the control arm will attend quarterly consultations of 30-45 minutes with a clinical exercise physiologist to discuss and promote recommended physical activity targets (150 minutes moderate physical activity per week), specific to their condition. Control group sessions will be offered over a 12-month period in parallel with the duration of the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 334008 0
Recurrence of any atrial fibrillation over 30s in duration, detected by implantable loop recorder, routine Holter monitoring or 12-lead electrocardiography.
Timepoint [1] 334008 0
18-month follow-up from date of AF ablation, excluding 3-month blanking period immediately following AF ablation.
Secondary outcome [1] 419054 0
Burden of atrial fibrillation, assessed as percentage of time in AF, measured by implantable loop recorder.
Timepoint [1] 419054 0
30-day period, terminating at 6, 12, 18, 24 and 36-months from date of AF ablation.
Secondary outcome [2] 419055 0
Left atrial maximal and minimal volume, indexed to body surface area, assessed using cardiac magnetic resonance imaging (MRI)
Timepoint [2] 419055 0
12-month post-ablation
Secondary outcome [3] 419056 0
Peak oxygen consumption (VO2peak), assessed with maximal cardiopulmonary exercise testing using a cycle ergometer.
Timepoint [3] 419056 0
12 and 18-month post-ablation
Secondary outcome [4] 419057 0
Atrial fibrillation symptom severity score, assessed using University of Toronto Atrial Fibrillation Symptom Severity Questionnaire (AFSS).
Timepoint [4] 419057 0
12 and 18-months post-ablation
Secondary outcome [5] 419058 0
Left atrial function during exercise, assessed using left atrial emptying fraction (LAEF) assessed using two-dimensional echocardiography during supine cycle exercise.
Timepoint [5] 419058 0
12 and 18-months post ablation
Secondary outcome [6] 419059 0
Cognitive function, assessed with CANTAB software (Motor Screening Task, Paired Associates Learning, Reaction Time and Spatial Working Memory tasks).
Timepoint [6] 419059 0
12 and 18-months post ablation
Secondary outcome [7] 419060 0
Blood Glucose Control, using assessment of serum glycated haemoglobin (HbA1c)
Timepoint [7] 419060 0
12 and 18-months post-ablation
Secondary outcome [8] 419061 0
Blood lipid profile, with point of care assessment of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol and plasma triglycerides.
Timepoint [8] 419061 0
12 and 18-months post ablation
Secondary outcome [9] 419062 0
In-office blood pressure, assessed using an automated sphygmomanometer after 5-mins seated rest.
Timepoint [9] 419062 0
12 and 18-months post ablation
Secondary outcome [10] 420459 0
Left ventricular function assessed during exercise using measures of left ventricular ejection fraction and global longitudinal strain during supine cycle ergometry
Timepoint [10] 420459 0
12 and 18-months post AF ablation
Secondary outcome [11] 420460 0
Assessment of cognitive function using Montreal Cognitive Assessment (MoCA)
Timepoint [11] 420460 0
12 and 18-months post-ablation
Secondary outcome [12] 421494 0
Epicardial fat volume assessed using cardiac magnetic resonance imaging
Timepoint [12] 421494 0
12-months
Secondary outcome [13] 421495 0
Left ventricular volume at end-diastole and end-systole using cardiac magnetic resonance imaging
Timepoint [13] 421495 0
12-months
Secondary outcome [14] 421496 0
Physical activity time (hours per day at moderate physical activity) using accelereometry data from implantable loop recorder
Timepoint [14] 421496 0
One week period at 3, 6, 9, 12, 18, 24 and 36-months post-ablation

Eligibility
Key inclusion criteria
Symptomatic patients with paroxysmal or persistent AF, scheduled for AF ablation, aged between 18 and 80 years (inclusive).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
AF ablation within past 12 months.
Cardiac surgery or myocardial infarction within the past 12 months.
Left ventricular systolic dysfunction (LV Ejection Fraction less than 45%)
Significant cardiac valvulopathy (except functional mitral and tricuspid regurgitation).
Active malignancy, active autoimmune or systemic inflammatory disease; severe renal or hepatic failure.
Unstable ventricular arrhythmias in the preceding 3 months.
Inability to participate in an exercise program due to musculoskeletal disease or other active diseases preventing participating in physical exercise.
Ongoing participation in exercise program >90 minutes per week.
Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained by use of central, computer-generated randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised using computer-generated randomisation sequences with random blocks of 2-6 patients. Randomisation will be stratified by type of AF (paroxysmal or persistent), determined from most recent medical record.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
24/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
226
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313298 0
University
Name [1] 313298 0
University of Adelaide
Country [1] 313298 0
Australia
Funding source category [2] 313299 0
Charities/Societies/Foundations
Name [2] 313299 0
The Hospital Research Foundation
Country [2] 313299 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Faculty of Health & Medical Sciences
University of Adelaide
4 North Terrace
Adelaide
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 315038 0
None
Name [1] 315038 0
N/A
Address [1] 315038 0
N/A
Country [1] 315038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312524 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 312524 0
Ethics committee country [1] 312524 0
Australia
Date submitted for ethics approval [1] 312524 0
27/02/2023
Approval date [1] 312524 0
28/04/2023
Ethics approval number [1] 312524 0
2023/HRE00048

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124970 0
Dr Adrian Elliott
Address 124970 0
Centre for Heart Rhythm Disorders
South Australian Health & Medical Research Institute
2 North Terrace
Adelaide
South Australia, 5000
Country 124970 0
Australia
Phone 124970 0
+61 8 8128 4648
Fax 124970 0
Email 124970 0
[email protected]
Contact person for public queries
Name 124971 0
Jenelle Dziano
Address 124971 0
Centre for Heart Rhythm Disorders
South Australian Health & Medical Research Institute
2 North Terrace
Adelaide
South Australia, 5000
Country 124971 0
Australia
Phone 124971 0
+61 8 8313 9000
Fax 124971 0
Email 124971 0
[email protected]
Contact person for scientific queries
Name 124972 0
Adrian Elliott
Address 124972 0
Centre for Heart Rhythm Disorders
South Australian Health & Medical Research Institute
2 North Terrace
Adelaide
South Australia, 5000
Country 124972 0
Australia
Phone 124972 0
+61 8 8128 4648
Fax 124972 0
Email 124972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18456Study protocol  [email protected]
18457Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.