Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-20 @ 11:06 PM
Study NCT ID:
NCT05375292
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2022-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, interventional, randomized, controlled, open study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional WHODAS 2.0 score', 'timeFrame': 'T0 : Right after the open surgery for AAA', 'description': 'the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities'}, {'measure': 'functional WHODAS 2.0 score', 'timeFrame': '3 months after the open surgery for AAA', 'description': 'the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aaa', 'prehabilitation', 'quality of life', 'physical therapy', 'open surgery'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.', 'detailedDescription': "Open surgery of abdominal aortic aneurysms (AAA) is the reference treatment in a large number of cases. This is a heavy procedure performed in patients around 70 years of age.\n\nIn post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients.\n\nThe goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living.\n\nThe pre-habilitation protocol includes 3 parts :\n\n1. Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism\n2. Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently\n3. Cardio-respiratory endurance.\n\nFor the experimental group:\n\nInitial visit with adaptive rehabilitation physician, 6-8 weeks prior to surgery:\n\n* Clinical examination with Wood classification - limits and restrictions.\n* Assessment of environmental resources\n* Definition pre-habilitation protocol and post-operative rehabilitation pathway\n* application of the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician.\n\nFor the control group:\n\nSupport without pre-approval with application of other common practices of the service.\n\nFollow up of both groups:\n\nPost-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).\n\nMail-out of World Health Organisation Disability Assessment Schedule (WHODAS) 2.0, Euro Qol (EQ)-5D-5L and DIJON questionnaires at 3 and 6 months post-operative."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Supra renal/Juxta-renal/Sub renal) treated with conventional surgery.\n* Surgical indication of aneurysm by size (50-55mm)\n\nExclusion Criteria:\n\n\\- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.'}, 'identificationModule': {'nctId': 'NCT05375292', 'acronym': 'EPOP-AORTA', 'briefTitle': 'Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm', 'orgStudyIdInfo': {'id': 'RC31/21/0618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREHABILITATION GROUP', 'description': "Initial visit with the adaptive rehabilitation physician, 6-8 weeks prior to surgery:\n\n* Clinical examination with Wood classification description of impairments, activity limits and participation restrictions.\n* Assessment of environmental resources\n* Definition with the patient of the extended ambulatory pre-habilitation protocol, identification with the post-operative rehabilitation pathway,\n* Provide the patient with a follow-up workbook of the personalized pre-approval protocol and, if the patient's condition requires it, orders for physiotherapy.\n\nThen apply the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician.\n\n\\- Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).\n\nMail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.", 'interventionNames': ['Other: PREHABILITATION']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL GROUP', 'description': 'Support without pre-approval with application of other common practices of the service.\n\nPost-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).\n\nMail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.'}], 'interventions': [{'name': 'PREHABILITATION', 'type': 'OTHER', 'description': 'Customized program made by the physical therapist based on the first visit.\n\nIt includes 3 parts :\n\n1. Nutrition advices that ensures adequate caloric and protein intake to support muscle anabolism\n2. Muscle building over a few sessions with a physiotherapist to learn exercises and then independently redo them\n3. Cardio-respiratory endurance exercises.', 'armGroupLabels': ['PREHABILITATION GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien Hostalrich, MD', 'role': 'CONTACT', 'email': 'hostalrich.a@chu-toulouse.fr', 'phone': '0561322620'}], 'facility': 'Uh Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Aurélien Hostalrich, MD', 'role': 'CONTACT', 'email': 'hostalrich.a@chu-toulouse.fr', 'phone': '05 61 32 26 20'}, {'name': 'Virgile Pinelli, MD', 'role': 'CONTACT', 'email': 'pinelli.v@chu-toulouse.fr', 'phone': '05 61 32 26 20'}], 'overallOfficials': [{'name': 'Aurélien Hostalrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}