Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 1:28 PM
Study NCT ID:
NCT02949505
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional capacity - incremental shuttle walk test', 'timeFrame': '12-weeks', 'description': 'incremental shuttle walk test'}, {'measure': 'Functional capacity - short performance battery test', 'timeFrame': '12-weeks'}, {'measure': 'Psychological wellbeing - HADS questionnaire', 'timeFrame': '12-weeks', 'description': 'HADS questionnaire'}, {'measure': 'Quality of Life - EQ-5D questionnaire', 'timeFrame': '12-weeks', 'description': 'EQ-5D questionnaire'}], 'primaryOutcomes': [{'measure': 'Number of participants with intervention-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '12-week', 'description': 'As this is a feasibility/Pilot study the investigators need to assess if any participants have any adverse events related to the home prehabilitation programme and if so, determine the severity and frequency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'liver transplant', 'functional capacity', 'exercise'], 'conditions': ['Liver Cirrhosis', 'Liver Dysfunction']}, 'referencesModule': {'references': [{'pmid': '29358444', 'type': 'DERIVED', 'citation': 'Williams FR, Vallance A, Faulkner T, Towey J, Kyte D, Durman S, Johnson J, Holt A, Perera MT, Ferguson J, Armstrong MJ. Home-based exercise therapy in patients awaiting liver transplantation: protocol for an observational feasibility trial. BMJ Open. 2018 Jan 21;8(1):e019298. doi: 10.1136/bmjopen-2017-019298.'}]}, 'descriptionModule': {'briefSummary': 'A UK prospective, single-centre feasibility study investigating the effects of exercise therapy on functional capacity in patients on the waiting list for liver transplantation. Patients will receive a 12-week home prehabilitation program (daily step program; functional resistance exercise sessions; telephone health call or virtual clinic). The following will be assessed at weeks 0, 6 and 12 weeks: feasibility (recruitment, compliance, safety, patients perception), functional capacity (ISWT, SPBT), psychological wellbeing (HADS questionnaire) and quality of life (EQ-5D)', 'detailedDescription': 'as above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the United Kingdom Liver Transplant criteria for listing\n* Accepted on the liver transplant waiting list for a primary transplant\n* Adults ≥18years who have an indication for a liver transplant\n* Diagnosed with sarcopenia at liver transplant assessment\n\nExclusion Criteria:\n\n* Significant cardiovascular instability including a recent Myocardial infarction, recent Cerebrovascular accident and/or a recent unstable arrhythmia\n* Unstable encephalopathy - open to interpretation by the chief investigator\n* Patient or next of kin non-English speaking\n* Inpatients\n* Refusal or lacks capacity to give informed consent'}, 'identificationModule': {'nctId': 'NCT02949505', 'briefTitle': 'Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'Impact of Exercise Therapy on Functional Capacity in Patients Listed for Liver Transplantation', 'orgStudyIdInfo': {'id': 'QEUHB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': '12-week home prehabilitation program', 'interventionNames': ['Behavioral: Home prehabilitation program']}], 'interventions': [{'name': 'Home prehabilitation program', 'type': 'BEHAVIORAL', 'description': '12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'James Ferguson, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizabeth University Hospital Birmingham'}, {'name': 'Felicity Williams', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Elizabeth University Hospital Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthew Armstrong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Elizabeth Hospital NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Specialist Registrar in Hepatology and Honorary Clinical Fellow', 'investigatorFullName': 'Matthew Armstrong', 'investigatorAffiliation': 'University of Birmingham'}}}}