跳至主要内容
临床试验/NCT07270757
NCT07270757招募中不适用

Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: A Randomized Controlled Trial

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Peak Oxygen Uptake at 3 months

研究概览

简要总结

The primary objective of this study is to compare the effects of a preoperative prehabilitation program versus usual care on post-procedural cardiorespiratory function and clinical outcomes in patients undergoing catheter ablation for atrial fibrillation.

详细描述

Background The comprehensive management of atrial fibrillation (AF) has evolved from mere rhythm control to improving patients' symptoms, functional status, and long-term prognosis. While catheter ablation effectively restores sinus rhythm, a significant clinical paradox exists: many patients fail to achieve ideal recovery in objective cardiorespiratory function and subjective quality of life even after technically successful procedures. This gap between "technical success" and "functional recovery" reveals major deficiencies in the current fragmented, procedure-centric management model.

The core of this deficiency lies in the systematic neglect of patients' physiological and psychological reserves during the perioperative period. Studies show that up to 70% of AF patients experience kinesiophobia (fear of movement), which becomes exacerbated during the perioperative period and severely hinders patients' willingness and compliance to participate in rehabilitation. Meanwhile, the high incidence of atrial arrhythmic events during the three-month post-operative "blanking period" not only increases clinical management complexity but also indirectly affects patients' functional recovery through medication adjustments and activity restrictions. These factors together form a "physiological-psychological" vicious cycle that ultimately affects patients' long-term outcomes.

Study Objectives This study aims to evaluate whether a physician-supervised structured preoperative prehabilitation program can serve as an effective integrated strategy to simultaneously improve both hard clinical outcomes and objective functional indicators in AF ablation patients.

Specific objectives include:

To evaluate the improvement effect of prehabilitation on peak oxygen uptake at 3 months post-ablation To evaluate the preventive effect of prehabilitation on atrial arrhythmic events within 90 days post-ablation To evaluate the improvement effect of prehabilitation on patient-reported outcomes (including kinesiophobia, quality of life, etc.)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-70 years
  • Scheduled for first AF ablation
  • NYHA class I-II

排除标准

  • Significant structural heart disease (e.g., severe valvular disease)
  • Contraindications to CPET or exercise training
  • Cognitive impairment preventing cooperation

结局指标

主要结局

Peak Oxygen Uptake at 3 months

时间窗: 3 months post-ablation

Measure: Cardiopulmonary exercise testing

Atrial Arrhythmic Events within 90 days

时间窗: Within 90 days post-ablation

Any atrial arrhythmic events happened within 90 days after the procedure

次要结局

未报告次要终点

研究者

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weizhu Ju

The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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