Atrial Fibrillation Clinical Trial
Official title:
Exercise-based Cardiac Rehabilitation for Patients With Atrial Fibrillation Receiving Catheter Ablation
The investigators aim to conduct a pilot randomised controlled trial (RCT) with embedded feasibility study to evaluate an exercise-based cardiac rehabilitation (ExCR) programme when delivered to patients with atrial fibrillation on the waiting list for catheter ablation. Our overall objective is to test the feasibility and acceptability of an evidence-based ExCR intervention prior to evaluation in a future randomized controlled trial (RCT).
A two-arm pilot randomised clinical trial (RCT) with embedded feasibility and process evaluation will be undertaken as a phased programme of work. Patients on a waiting list for catheter ablation will be offered a referral to cardiac rehabilitation. The intervention consists of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions. Phase 1 (n=20) and phase 2 (n=60) will involve two National Health Service (NHS) research sites, Liverpool Heart and Chest NHS Foundation Trust and Wirral Community Health and Care NHS Foundation Trust enrolling patients to assess intervention and study design processes. Primary outcomes are recruitment rate, adherence to the ExCR and loss to follow-up. Semi-structured interviews and focus groups with patients and clinicians will be used to gather data on the acceptability of the intervention and study procedures. Secondary outcome measures will be taken at baseline (preintervention), postintervention and at 6 month follow-up for both phases and will consist of exercise capacity measured by AF burden, AF recurrence, quality of life, exercise capacity, and cardiac structure and function. ;
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