Skip to content

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07270757
Enrollment
100
Registered
2025-12-08
Start date
2025-02-01
Completion date
2026-03-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation, Cardiac rehabilitation

Brief summary

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.

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.

Interventions

OTHER4-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.

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peak Oxygen Uptake at 3 months3 months post-ablationMeasure: Cardiopulmonary exercise testing
Atrial Arrhythmic Events within 90 daysWithin 90 days post-ablationAny atrial arrhythmic events happened within 90 days after the procedure

Countries

China

Contacts

Primary ContactKexin Wang
840507356@qq.com+8618018223427

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026