Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients
NCT ID: NCT07270757
Last Updated: 2025-12-08
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-02-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Prehabilitation Group
Structured Prehabilitation Program for 4 weeks before ablation
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.
Usual Care Group
Standard Preoperative Care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for first AF ablation
3. NYHA class I-II
4. LVEF ≥ 50%
Exclusion Criteria
2. Contraindications to CPET or exercise training
3. Cognitive impairment preventing cooperation
18 Years
70 Years
ALL
No
Sponsors
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Nanjing Medical University
OTHER
Responsible Party
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Weizhu Ju
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital with Nanjing Medical University
Nanjing, Please Select, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-SR-429
Identifier Type: -
Identifier Source: org_study_id
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