Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom.
Centre for Healthcare & Communities, Coventry University, Coventry, United Kingdom.
PLoS One. 2024 Oct 3;19(10):e0310951. doi: 10.1371/journal.pone.0310951. eCollection 2024.
Atrial fibrillation (AF) is associated with significant morbidity/mortality. AF-ablation is an increasingly used treatment. Currently, first-time AF-ablation success is 40-80% at 1-year, depending on individual factors. There is growing evidence for improved outcomes through management of AF risk-factors/comorbidities via patient education/exercise-rehabilitation. There are no studies assessing combined prehabilitation/rehabilitation in this cohort. The aim of this randomised controlled trial is to assess efficacy of comprehensive prehabilitation/rehabilitation and combining supervised exercise-training with AF risk-factor modification/education compared with standard care in people undergoing first-time AF ablation.
This single-centre pragmatic randomised controlled trial will recruit 106 adults with paroxysmal/persistent AF listed for first-time AF-ablation. Participants will be randomised 1:1 to cardiac prehabilitation/rehabilitation/education (CREED AF) intervention or standard care. Both groups will undergo AF-ablation at 8-weeks post-randomisation as per usual care. The CREED AF intervention will involve 6-weeks of prehabilitation (before AF-ablation) followed by 6-weeks rehabilitation (after AF-ablation) consisting of risk factor education/modification and supervised exercise training. Standard care will include a single 30-minute session of risk-factor education. Outcomes will be measured at baseline, 10-weeks and 12-months post AF-ablation, by researchers blinded to treatment allocation. The primary outcome is cardiorespiratory-fitness (peak oxygen uptake, VO2peak) assessed using cardiopulmonary exercise testing (CPET) at 10-weeks post-ablation. Secondary outcomes include health-related quality of life, AF recurrence/burden assessed by 7-day Holter-monitor, requirement for repeat AF-ablation, study defined major adverse cardiovascular events, and cost-effectiveness (incremental cost per quality-adjusted life year (QALY)).
This study will assess clinical-efficacy/cost-effectiveness of comprehensive prehabilitation/rehabilitation/patient-education for people undergoing first time AF-ablation. Results will inform clinical care and design of future multi-centre clinical trials.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.
心房颤动（AF）与显著的发病率/死亡率相关。AF 消融术是一种越来越常用的治疗方法。目前，根据个体因素的不同，首次 AF 消融术的 1 年成功率为 40-80%。通过对患者进行教育/运动康复来管理 AF 风险因素/合并症，有越来越多的证据表明可以改善结果。目前还没有研究评估这一队列中综合康复/康复的作用。本随机对照试验的目的是评估全面康复/康复以及将监督运动训练与 AF 风险因素修正/教育相结合，与首次 AF 消融术标准护理相比，在接受首次 AF 消融术的人群中的疗效。
这项单中心实用随机对照试验将招募 106 名接受阵发性/持续性 AF 消融术的成人。参与者将按 1:1 随机分为心脏康复/教育（CREED AF）干预组或标准护理组。两组均将在随机分组后 8 周内进行 AF 消融术，如常规护理。CREED AF 干预措施将包括 6 周的预康复（在 AF 消融术之前）和 6 周的康复（在 AF 消融术之后），包括风险因素教育/修正和监督运动训练。标准护理将包括一次 30 分钟的风险因素教育。研究人员将在 AF 消融后 10 周和 12 个月时对研究对象进行盲法评估，以评估研究对象的心肺适能（峰值摄氧量，VO2peak）。次要结果包括使用心肺运动试验（CPET）评估的健康相关生活质量、AF 复发/负担（通过 7 天动态心电图监测评估）、重复 AF 消融术的需求、研究定义的主要心血管不良事件以及成本效益（每增加一个质量调整生命年（QALY）的增量成本）。
这项研究将评估对首次接受 AF 消融术的患者进行全面康复/教育/患者教育的临床疗效/成本效益。结果将为临床护理提供信息，并为未来的多中心临床试验设计提供信息。
网址：https://www.clinicaltrials.gov；唯一标识符：NCT06042231。登记日期：2023 年 9 月 18 日。
