Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05033327
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2020-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chair Sit-to-Stand', 'timeFrame': '12 weeks', 'description': 'The change in time required to complete 5x sit-to-stands from baseline to end of study.'}, {'measure': 'Thigh Muscle Measures', 'timeFrame': '12 weeks', 'description': 'The change in thigh muscle thickness and echogenicity from baseline to end of study.'}], 'primaryOutcomes': [{'measure': 'Participant Retention/Adherence', 'timeFrame': '12 weeks', 'description': 'The number of participants who complete the 12-week nutrition and exercise program and meet 70% of the nutrition and exercise goals.'}], 'secondaryOutcomes': [{'measure': '6-MWT', 'timeFrame': '12 weeks', 'description': 'The change in distance walked in 6 minutes.'}, {'measure': 'Program Satisfaction', 'timeFrame': '12 weeks', 'description': 'Self-reported satisfaction with the nutrition and exercise program.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis, Liver', 'Hepatic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '29964066', 'type': 'BACKGROUND', 'citation': 'Tandon P, Ismond KP, Riess K, Duarte-Rojo A, Al-Judaibi B, Dunn MA, Holman J, Howes N, Haykowsky MJF, Josbeno DA, McNeely M. Exercise in cirrhosis: Translating evidence and experience to practice. J Hepatol. 2018 Nov;69(5):1164-1177. doi: 10.1016/j.jhep.2018.06.017. Epub 2018 Jun 30.'}, {'pmid': '29738109', 'type': 'BACKGROUND', 'citation': 'Eslamparast T, Montano-Loza AJ, Raman M, Tandon P. Sarcopenic obesity in cirrhosis-The confluence of 2 prognostic titans. Liver Int. 2018 Oct;38(10):1706-1717. doi: 10.1111/liv.13876. Epub 2018 May 25.'}, {'pmid': '29072825', 'type': 'BACKGROUND', 'citation': 'Mazurak VC, Tandon P, Montano-Loza AJ. Nutrition and the transplant candidate. Liver Transpl. 2017 Nov;23(11):1451-1464. doi: 10.1002/lt.24848.'}, {'pmid': '28361840', 'type': 'BACKGROUND', 'citation': 'Ney M, Gramlich L, Mathiesen V, Bailey RJ, Haykowsky M, Ma M, Abraldes JG, Tandon P. Patient-perceived barriers to lifestyle interventions in cirrhosis. Saudi J Gastroenterol. 2017 Mar-Apr;23(2):97-104. doi: 10.4103/1319-3767.203357.'}, {'pmid': '27539029', 'type': 'BACKGROUND', 'citation': 'Ney M, Haykowsky MJ, Vandermeer B, Shah A, Ow M, Tandon P. Systematic review: pre- and post-operative prognostic value of cardiopulmonary exercise testing in liver transplant candidates. Aliment Pharmacol Ther. 2016 Oct;44(8):796-806. doi: 10.1111/apt.13771. Epub 2016 Aug 19.'}, {'pmid': '24768811', 'type': 'BACKGROUND', 'citation': 'Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.'}], 'seeAlsoLinks': [{'url': 'http://www.wellnesstoolbox.ca', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': 'The personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. The pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.', 'detailedDescription': "Patients living with chronic disease are at-risk for frailty because of their potentially sedentary lifestyle and/or symptoms. Supervised exercise programs are useful for improving or maintaining physical capacity as measured by common physical function measures. However, accessibility is limited due to scheduling, transportation, employment, and residential location. Unsupervised, self-directed home-based programs have had limited success due to absence of peer support and accountability.\n\nAn alternative is an app-based program that offers interactive engagement with study staff and accountability. Further, follow-along videos and tracking for both nutrition and exercise can be completed at the patient's convenience.\n\nA 12-week pilot study with patients living with cirrhosis will assess the acceptability of the programming. The hypothesis is that study participants will find the customization of the app and interaction with the study staff acceptable as measured by completion rates (primary study endpoint). Secondary outcomes include change in measures (0-12 weeks) for the 6-minute walk test (6MWT), thigh muscle thickness, and chair sit-to-stands. At the end of the study, participants will also complete a program satisfaction survey (developed in-house).\n\nInterviews with participants, caregivers, and study staff, conducted via videoconference at 4-6 weeks and end of study, will be descriptively analysed to identify feasibility, acceptability, and perceived utility of the program. Analyses will also identify areas for program improvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (aged 18 years and older)\n* diagnosis of cirrhosis (MELD\\<25) according to biopsy, imaging, elastography, or other\n* fulfill the guideline-based prophylaxis in place for high risk gastroesophageal varices\n* able to communicate (e.g., speak, read, and write) in English\n* provide informed written consent for self\n\nExclusion Criteria:\n\n* hepatocellular carcinoma (HCC) outside of the Edmonton liver transplant criteria\n* previous myocardial infarction\n* EF \\<50%\n* ischemia on stress testing\n* oxygen saturation \\<95%\n* non-HCC malignancy\n* end-stage renal disease.\n* at the discretion of the healthcare team if a participant can participate in the pilot study'}, 'identificationModule': {'nctId': 'NCT05033327', 'briefTitle': 'Feasibility of an App-based Nutrition & Exercise Program in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'The Acceptability of an App-based, Interactive, Personalized Nutrition and Exercise Program to Support Self-management in Cirrhosis: a Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00087451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nutrition and Exercise App', 'description': 'The exercise and nutrition app intervention will be provided to study participants. The app offers self-directed and supervised (virtual) programming to support nutrition and exercise self-management. Each participant follows a program that has been tailored to their overall health, physical function, and needs.', 'interventionNames': ['Behavioral: Nutrition and Exercise app']}], 'interventions': [{'name': 'Nutrition and Exercise app', 'type': 'BEHAVIORAL', 'otherNames': ['Heal-Me'], 'description': 'Personalized, home-based, interactive therapy app', 'armGroupLabels': ['Nutrition and Exercise App']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Puneeta Tandon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian National Transplant Research Program', 'class': 'OTHER'}, {'name': 'Nutricia Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}