Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 26, 2025
CompletedFirst Posted
Study publicly available on registry
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedDecember 8, 2025
October 1, 2025
1 year
November 26, 2025
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Prehabilitation Group
EXPERIMENTALStructured Prehabilitation Program for 4 weeks before ablation
Usual Care Group
NO INTERVENTIONStandard Preoperative Care
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 Delivery mode: Hybrid (supervised in-hospital sessions + monitored home-based sessions) The usual care group will receive only standard preoperative education without structured rehabilitation.
Eligibility Criteria
You may qualify if:
- Aged 18-70 years
- Scheduled for first AF ablation
- NYHA class I-II
- LVEF ≥ 50%
You may not qualify if:
- Significant structural heart disease (e.g., severe valvular disease)
- Contraindications to CPET or exercise training
- Cognitive impairment preventing cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Please Select, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The First Affiliated Hospital with Nanjing Medical University
Study Record Dates
First Submitted
November 26, 2025
First Posted
December 8, 2025
Study Start
February 1, 2025
Primary Completion
February 1, 2026
Study Completion
March 1, 2026
Last Updated
December 8, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share