Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT04265235
Status:
TERMINATED
Last Update Posted:
2020-07-08
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm Exercise Intervention study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'COVID pandemic. Recruited 31 out of target 40 patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-05', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PBC-40 Quality of Life for Primary Biliary Cirrhosis', 'timeFrame': '12 weeks', 'description': 'PBC-40 is a quality of life questionnaire (validated) with the domains of cognitive, social, emotional and overall symptom burden. 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact)'}], 'secondaryOutcomes': [{'measure': 'Health Anxiety Depression Score (HADS)', 'timeFrame': '12 weeks', 'description': 'Questionnaire - out of 24. higher score means worse depression and anxiety'}, {'measure': 'hand grips strength (kg)', 'timeFrame': '12 weeks', 'description': 'measures of muscle strength'}, {'measure': 'liver frailty index', 'timeFrame': '12 weeks', 'description': 'index based on hand grip strength, chair stands, balance. higher the value the more frail.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Fatigue', 'Liver'], 'conditions': ['Primary Biliary Cholangitis']}, 'referencesModule': {'references': [{'pmid': '39640219', 'type': 'DERIVED', 'citation': 'Freer A, Williams FR, Durman S, Hayden J, Armstrong MJ, Trivedi PJ. A home-based exercise programme attenuates fatigue in primary biliary cholangitis: Results from the EXCITED clinical trial. JHEP Rep. 2024 Sep 6;6(12):101210. doi: 10.1016/j.jhepr.2024.101210. eCollection 2024 Dec.'}, {'pmid': '33707216', 'type': 'DERIVED', 'citation': 'Freer A, Williams F, Durman S, Hayden J, Trivedi PJ, Armstrong MJ. Home-based exercise in patients with refractory fatigue associated with primary biliary cholangitis: a protocol for the EXerCise Intervention in cholesTatic LivEr Disease (EXCITED) feasibility trial. BMJ Open Gastroenterol. 2021 Mar;8(1):e000579. doi: 10.1136/bmjgast-2020-000579.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, single centre, single-arm, pilot study investigating the safety and efficacy of a 12-week remotely-monitored home-based exercise program in patients with refractory fatigue (based on PBC-40 Quality of Life measure) secondary to Primary Biliary Cirrhosis.', 'detailedDescription': 'Recruitment from the research nurse-led PBC clinic: Eligibility screen followed by recruitment letters being sent to patients.\n\nThe outpatient clinic review by the liver specialist physiotherapist (week 0):\n\nPatients will undergo a baseline assessment of quality of life, anthropometry, functional capacity (with validated tools including the incremental shuttle walk test and short performance battery test) and exercise tolerance. At the same visit, patients will be prescribed and trained to perform the individualised Home-based Exercise Program. Patients will be provided with an accelerometer to assess daily step count and a symptoms/side effects diary.\n\nSix weeks of telephone support (weeks 0-6):\n\nPatients will be telephoned weekly over a period of 6 weeks, in order to evaluate compliance with therapy and any difficulties encountered. At each phone call, the daily step count and the intensity of the resistance-exercises will be adjusted to the patients ability.\n\nThe outpatient clinic review by the liver specialist physiotherapist (week 6 +/- 5 days): Reassessment of baseline parameters of quality of life, functionality and exercise tolerance; and modification of step count targets and resistance-exercise intervention as needed.\n\nThe outpatient clinic review by the liver specialist physiotherapist (week 12 +/- 5 days): Reassessment of baseline parameters of quality of life, functionality and exercise tolerance; and modification of step count targets and resistance-exercise intervention as needed.\n\nValidate the efficacy of exercise intervention: Given that the goal is to improve fatigue-related symptoms and thus patient quality of life, the investigators will determine the interim efficacy and longevity of intervention using a multi-modal patient-reported outcome approach. This will principally be through changes in validated quality of life (QoL) scoring measures at baseline and during sequential study visits; including the fatigue domain of the PBC-40 QoL measure (primary outcome measure), in addition to the relevant PBC-40 domains of cognitive, social, emotional and overall symptom burden; the Hospital Anxiety and Depression Scale (HADS); Epworth Sleepiness Scale to assess daytime somnolence; Patient-Reported Outcomes Measurement Information System Health Assessment Questionnaire (PROMIS-HAQ®) to assess functional status, and the Cognitive Failure questionnaire (COGFAIL) to determine cognitive functionality.\n\nAll data will be collated onto a standardised clinical case record form. Outcomes will be audited after 6 months to determine whether the intervention has proven beneficial to patients, and whether improvements in functional status correlate with changes in fatigue and QoL scores'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years Old\n* A confirmed diagnosis of PBC through clinical observation as per guidance of BSG/ EASL\n* Fatigue Impact Scale \\>40\n* Access to a SMART Phone or Computer\n\nExclusion Criteria:\n\n* Decompensated PBC with the following clinical signs:\n* Moderate Ascites\n* A Bilirubin of \\>50\n* Variceal Bleed \\< 6 Months\n* Encephalopathic\n* Refractory Pruritis (Judged by PI)\n* Cardiovascular Instability (Judged by PI)\n* Untreated Vitamin Deficiency\n* Untreated hypothyroidism\n* Untreated Coeliac Disease\n* WHO Performance Status \\> 3\n* History of Unexplained Falls'}, 'identificationModule': {'nctId': 'NCT04265235', 'acronym': 'EXCITED', 'briefTitle': 'EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study', 'orgStudyIdInfo': {'id': 'RRK6589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based Exercise Program', 'description': '12-weeks, remotely monitored home-based exercise program consisting or aerobic and resistance exercise', 'interventionNames': ['Other: Home-based exercise program']}], 'interventions': [{'name': 'Home-based exercise program', 'type': 'OTHER', 'description': "see 'arm' section", 'armGroupLabels': ['Home-based Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B152TH', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Liver Unit, University Hospital Birminghmam', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Birmingham NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Intercept Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Liver and Transplant Medicine, Honorary Clinical research Fellow and Principal Investigator', 'investigatorFullName': 'Matthew Armstrong', 'investigatorAffiliation': 'University of Birmingham'}}}}