Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 5:51 PM
Study NCT ID:
NCT04034433
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Program for Arteriovenous Fistula Maturation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arteriovenous Fistula (AVF diameter)', 'timeFrame': 'at 6 weeks (after surgery)', 'description': 'Arteriovenous Fistula diameter will be measured by Doppler ultrasound'}], 'secondaryOutcomes': [{'measure': 'Echographic maturation rate', 'timeFrame': 'at 6 weeks (after surgery)', 'description': 'Maturation rate of Arteriovenous Fistula (AVF) by echography defined as blood flow\\>600milliLiters/minute (mL/min), diameter\\>6millimeters (mm) and depth \\<6mm'}, {'measure': 'Clinical maturation rate', 'timeFrame': 'at 6 weeks (after surgery)', 'description': 'Arteriovenous Fistula (AVF) measured by a vein easily palpable, relatively straight, with a uniform sensation of quivering and more than 10centimeters (cm) long.'}, {'measure': 'Arteriovenous Fistula (AVF) localization (arm or forearm)', 'timeFrame': 'at 6 weeks (after surgery)', 'description': "After the patient's examination, the vascular surgeon will choose the future AVF localization"}, {'measure': 'Arteriovenous Fistula (AVF) interventions', 'timeFrame': 'up to 6 weeks', 'description': 'Necessity of performing an intervention (such as angioplasty or thrombolysis or thrombectomy or superficialization) on the Arteriovenous Fistula (AVF)'}, {'measure': 'Emergency hemodialysis on Central Venous Catheter (CVC)', 'timeFrame': 'up to 6 weeks', 'description': 'Necessity of patients on CVC to undergo emergency hemodialysis'}, {'measure': 'Emergency hemodialysis on Arteriovenous Graft (AVG)', 'timeFrame': 'up to 6 weeks', 'description': 'Necessity of patients on AVG to undergo emergency hemodialysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arteriovenous Fistula Diameter', 'Handgrip', 'Program exercise', 'Maturation'], 'conditions': ['Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': 'Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC).\n\nUnfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter.\n\nThe aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* with chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) \\<30 milliLiter/minute (mL/min))\n* with follow-up at the University Hospital of Lyon Sud\n* who choose hemodialysis as renal replacement therapy\n\nExclusion Criteria:\n\n* contraindication for arteriovenous fistula (AVF) surgery\n* refusing AVF creation\n* prior vascular access\n* antecedent of IV substance abuse\n* active cancer\n* inability to perform handgrip exercise\n* physical or mental disability limiting follow-up possibility\n* inclusion in an other interventional study\n* no social welfare'}, 'identificationModule': {'nctId': 'NCT04034433', 'acronym': 'FAVULOUS', 'briefTitle': 'Exercise Program for Arteriovenous Fistula Maturation', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas', 'orgStudyIdInfo': {'id': '69HCL19_0215'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2019-A00767-50'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'interventionNames': ['Procedure: Handgrip exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Handgrip exercise program', 'type': 'PROCEDURE', 'description': 'Handgrip exercise with a rubber ball 4 weeks before the surgery until 4 weeks after the surgery 20 contractions per minute for a total of 20 minutes each day.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia KOPPE, MD', 'role': 'CONTACT', 'email': 'laetitia.koppe@chu-lyon.fr', 'phone': '04.72.67.87.03'}, {'name': 'Solenne PELLETIER, MD', 'role': 'CONTACT'}, {'name': 'Mathilde NOUVIER, MD', 'role': 'CONTACT'}, {'name': 'Elodie CHALENÇON, MD', 'role': 'CONTACT'}, {'name': 'Etienne NOVEL-CATIN, MD', 'role': 'CONTACT'}], 'facility': 'Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Abbas DEEB, PhD', 'role': 'CONTACT', 'email': 'abbas.deeb@chu-lyon.fr', 'phone': '04.72.67.87.03', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Abbas DEEB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}