Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
Study NCT ID:
NCT07270757
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Oxygen Uptake at 3 months', 'timeFrame': '3 months post-ablation', 'description': 'Measure: Cardiopulmonary exercise testing'}, {'measure': 'Atrial Arrhythmic Events within 90 days', 'timeFrame': 'Within 90 days post-ablation', 'description': 'Any atrial arrhythmic events happened within 90 days after the procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Cardiac rehabilitation'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nStudy 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.\n\nSpecific objectives include:\n\nTo 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.)\n\nStudy 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.\n\nInterventions\n\nThe prehabilitation group will receive a 4-week structured program before ablation, including:\n\nIndividualized 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.\n\nAssessment and Follow-up Main assessment timepoints include baseline, 3 months post-ablation, and 6 months post-ablation.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-70 years\n2. Scheduled for first AF ablation\n3. NYHA class I-II\n4. LVEF ≥ 50%\n\nExclusion Criteria:\n\n1. Significant structural heart disease (e.g., severe valvular disease)\n2. Contraindications to CPET or exercise training\n3. Cognitive impairment preventing cooperation'}, 'identificationModule': {'nctId': 'NCT07270757', 'briefTitle': 'Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Atrial Fibrillation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Impact of Pre-Ablation Prehabilitation on Clinical Outcomes and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-SR-429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation Group', 'description': 'Structured Prehabilitation Program for 4 weeks before ablation', 'interventionNames': ['Other: 4-week structured prehabilitation program (exercise training + psychological education)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': 'Standard Preoperative Care'}], 'interventions': [{'name': '4-week structured prehabilitation program (exercise training + psychological education)', 'type': 'OTHER', 'description': 'The prehabilitation group will receive a 4-week structured program before ablation, including:\n\nIndividualized exercise training: Prescription based on cardiopulmonary exercise test results, including aerobic exercise (40%-60% of heart rate reserve) and resistance training\n\nPsychological and educational intervention: Structured education based on cognitive behavioral therapy principles, focusing on addressing kinesiophobia\n\nDelivery mode: Hybrid (supervised in-hospital sessions + monitored home-based sessions)\n\nThe usual care group will receive only standard preoperative education without structured rehabilitation.', 'armGroupLabels': ['Prehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Please Select', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kexin Wang', 'role': 'CONTACT', 'email': '840507356@qq.com', 'phone': '+8618018223427'}, {'name': 'Weizhu Ju', 'role': 'CONTACT', 'email': 'juweizhu@126.com'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Kexin Wang', 'role': 'CONTACT', 'email': '840507356@qq.com', 'phone': '+8618018223427'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital with Nanjing Medical University', 'investigatorFullName': 'Weizhu Ju', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}