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NCT Number: NCT07270757

Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.)

Study Design This is a prospective, single-center, assessor-blinded randomized controlled trial. We plan to enroll 100 eligible patients who will be randomly allocated in a 1:1 ratio to either the prehabilitation group or the usual care group.

Interventions

The prehabilitation group will receive a 4-week structured program before ablation, including:

Individualized exercise training: Prescription based on cardiopulmonary exercise test results, including aerobic exercise (40%-60% of heart rate reserve) and resistance training Psychological and educational intervention: Structured education based on cognitive behavioral therapy principles, focusing on addressing kinesiophobia The usual care group will receive only standard preoperative education without structured rehabilitation.

Assessment and Follow-up Main assessment timepoints include baseline, 3 months post-ablation, and 6 months post-ablation.

Primary endpoints: Peak oxygen uptake, incidence of atrial arrhythmic events Secondary endpoints: Other cardiorespiratory parameters, patient-reported outcomes, clinical events Safety indicators: Adverse events, program adherence Statistical Methods Intention-to-treat analysis will be applied. Continuous variables will be analyzed using ANCOVA, categorical variables using chi-square test, and time-to-event data using Kaplan-Meier survival analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-70 years
  • Scheduled for first AF ablation
  • NYHA class I-II
  • LVEF ≥ 50%

Exclusion criteria

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

Treatment and study plan

4-week structured prehabilitation program (exercise training + psychological education)

Other

The prehabilitation group will receive a 4-week structured program before ablation, including:

Individualized exercise training: Prescription based on cardiopulmonary exercise test results, including aerobic exercise (40%-60% of heart rate reserve) and resistance training

Psychological and educational intervention: Structured education based on cognitive behavioral therapy principles, focusing on addressing kinesiophobia

Delivery mode: Hybrid (supervised in-hospital sessions + monitored home-based sessions)

The usual care group will receive only standard preoperative education without structured rehabilitation.

Primary outcomes

  1. Peak Oxygen Uptake at 3 months

    Time frame: 3 months post-ablation

    Measure: Cardiopulmonary exercise testing

  2. Atrial Arrhythmic Events within 90 days

    Time frame: Within 90 days post-ablation

    Any atrial arrhythmic events happened within 90 days after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Kexin Wang

CONTACT

[email protected]

+8618018223427

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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