Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT04924595
Status:
UNKNOWN
Last Update Posted:
2021-06-14
First Post:
2021-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention in Liver Transplant Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline "Liver Frailty Index" value at 12 weeks', 'timeFrame': 'After 12-week exercise intervention', 'description': 'A frailty index for patients with cirrhosis, comprised of three performance-based metrics'}, {'measure': 'Change from Baseline "6 Minute Walking Test" value at 12 weeks', 'timeFrame': 'After 12-week exercise intervention', 'description': 'A walking test for patients to evaluate their functional capacity'}], 'secondaryOutcomes': [{'measure': 'VO2max', 'timeFrame': 'Before intervention initiation and after 12-week exercise intervention', 'description': 'Maximum oxygen consumption during incremental exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".\n\nExclusion Criteria:\n\n* Recent (\\<12 months) Acute Myocardial Infraction\n* Recent (\\<12 months) brain strokes\n* Uncontrolled and/or untreated arrythmia\n* Hepatic encephalopathy\n* Bed-bound patient\n* Liver Transplantation\n* Death'}, 'identificationModule': {'nctId': 'NCT04924595', 'briefTitle': 'Exercise Intervention in Liver Transplant Candidates', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation', 'orgStudyIdInfo': {'id': 'AUTh65/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention', 'interventionNames': ['Behavioral: Personalised exercise']}], 'interventions': [{'name': 'Personalised exercise', 'type': 'BEHAVIORAL', 'description': 'Personalised exercise intervention including aerobic and resistance training', 'armGroupLabels': ['Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57001', 'city': 'Thermi', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Laboratory of Sports Medicine', 'geoPoint': {'lat': 40.54712, 'lon': 23.01967}}, {'zip': '54642', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'country': 'Greece', 'facility': 'Surgical Department of Transplantation A.U.Th.', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Ilias M Oikonomou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Associate for the Surgical Department of Transplantation A.U.Th., Postgraduate Student, Medical Doctor', 'investigatorFullName': 'Ilias Marios Oikonomou', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}