Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation

This is a single centre, prospective, randomised controlled trial. The CREED AF study will run from University Hospitals Coventry & Warwickshire (UHCW) NHS Trust. There will be collaboration with Atrium Health, a non-profit exercise rehabilitation centre located in Coventry, UK. Atrium Health was founded by frontline NHS clinical staff to provide people with tailored exercise and education programmes. Patients with AF who are referred for first-time AF ablation at University Hospitals Coventry & Warwickshire NHS Trust will be recruited to the trial. The aim is to explore the effectiveness of a tailored comprehensive cardiac rehabilitation programme (both before and after the planned AF ablation) comprising of an exercise programme and patient education programme incorporating lifestyle behaviour change (CREED AF intervention), compared to standard care (control arm).

The CREED AF intervention will involve a cardiac pre/rehabilitation exercise training programme combined with a patient education programme.

To ensure generalisability for future trials, provisions will be based on current delivery models of cardiac rehabilitation in cardiovascular diseases. A 6-8-week supported programme of 2-3 times weekly exercise will be delivered with an initial individual assessment for each patient randomised to the intervention. Participants will attend a one-to-one appointment with a 'CREED AF practitioner' (specialist cardio-pulmonary clinical exercise physiologist or physiotherapist) for the assessment of medical history, medication, clinical parameters, physical activity history and discussion of participant goals, expectations, fears, and concerns. Patients randomised to the CREED AF intervention will have access to both existing cardio-pulmonary rehabilitation programmes at the Atrium Health Centre, Coventry (i.e., they will exercise alongside people with a range of cardio-pulmonary disorders at already running sessions) AND instructor-led, at home workout sessions that will take place live over a video conferencing software. It is anticipated that participants randomised to the CREED AF intervention will choose to receive a hybrid of the two approaches to reduce travel constraints of getting to and from the Atrium Health Centre, and to work more flexibly around a participant's working/personal life. To maximise accessibility and resource, whilst ensuring benefits are retained, the CREED AF intervention will be delivered as a 'rolling' programme. Participants randomised to the CREED AF intervention can immediately join existing cardio-pulmonary rehabilitation exercise programmes rather than waiting for the recruitment of sufficient numbers to form a discrete group of trial participants.

Cardiac pre/rehabilitation This will be a tailored, individualised exercise programme within pre-specified parameters. Clinical information, data from the exercise assessment, and patient-centred goal setting will be used to devise a safe and effective exercise prescription which can be performed either using pre-existing cardiopulmonary exercise groups at Atrium Health or using the instructor-led online classes that will be available. Exercise guidance, specific to AF, will be delivered on an individual basis during a 1-to-1 familiarisation exercise session in the first week of the programme, and reinforced throughout, by clinical staff. Familiarisation sessions, conducted within the cardiopulmonary rehabilitation programmes will enable participants to build their confidence and there will be optimisation of the exercise prescribed.

The cardiac rehabilitation can be undertaken within existing cardio-pulmonary rehabilitation programmes delivered by NHS clinical staff. Up to 3 times weekly, one hour, exercise sessions for 6-8 weeks before and for 6-8 weeks after AF ablation, with a quantifiable and progressive dose of individualised, multi-modal, aerobic, muscular strength, endurance and 'functional fitness' exercise. Adequate warm-up and cool-down will be incorporated. Intensity can be monitored and adjusted using heart rate (where appropriate), rating of perceived exertion, and dyspnoea scale. There is normally a 1-2-week recovery period after an AF ablation procedure to allow for femoral access site wound healing. Only after the participant has completed this 2-week recovery period will they restart their exercise intervention.