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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Other: 4-week structured prehabilitation program (exercise training + psychological education)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kexin Wang; Phone Number: +8618018223427; Email: 840507356@qq.com

Study Locations

• China
  • Please Select
    • Nanjing, Please Select, China
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Kexin Wang; Phone Number: +8618018223427; Email: 840507356@qq.com
      • Contact: Weizhu Ju; Email: juweizhu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-70 years
2. Scheduled for first AF ablation
3. NYHA class I-II
4. LVEF ≥ 50%

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation Group; Structured Prehabilitation Program for 4 weeks before ablation	Other: 4-week structured prehabilitation program (exercise training + psychological education); 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.
No Intervention: Usual Care Group; Standard Preoperative Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Oxygen Uptake at 3 months	Measure: Cardiopulmonary exercise testing	3 months post-ablation
Atrial Arrhythmic Events within 90 days	Any atrial arrhythmic events happened within 90 days after the procedure	Within 90 days post-ablation

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2025-SR-429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No