[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508347":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":104,"collaborators":18,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":18,"enrollmentInfo":116,"targetDuration":18,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prehabilitation Group","EXPERIMENTAL","The prehabilitation group will be provided with access to the online digital web platform which contains the weekly acceptance and commitment therapy based education videos, nutrition intervention, and exercise intervention.",[13],"Behavioral: Prehabilitation Programming",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","This group will receive standard care for LT candidates with cirrhosis and will be provided with standard online exercise, nutrition, and behavioural resources. Control participants will not receive access to the online digital platform.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Prehabilitation Programming","12-weeks of online prehabilitation programming including:\n\n1.12 weeks of nutrition programming focused on achieving a guideline- based protein intake of 1.2-1.5 g\u002Fkg\u002Fday. Participants will participate in a dietitian assessment and 0-2 dietitian follow-ups stratified by risk and 5 virtual group nutrition classes. Participants will be provided with a whey protein powder supplement - dosing stratified by risk.\n\n2.10 weeks of exercise programming focused on completion of 3 full- body resistance\u002Faerobic exercise sessions weekly (1 or 2 virtual group classes as per patient preference + 1 or 2 pre-recorded home exercise videos).\n\n3.12 weeks of acceptance and commitment therapy based educational videos and online activities focused on reducing stress and anxiety and improving motivation and adherence.",[9],[26],{"name":27,"affiliation":5,"role":28},"Puneeta Tandon","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","780-492-9844","ptandon@ualberta.ca",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Margaret McNeely","780-248-1531","margie.mcneely@ualberta.ca",[39,53,65,75,85,94],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":18},"Foothills Medical Centre","RECRUITING","Calgary","Alberta","T2N 2T9","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-114.08529,51.05011,{"lat":51,"lon":50},{"facility":54,"status":41,"city":55,"state":43,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Kaye Edmonton Clinic","Edmonton","T6G1Z1",{"type":48,"coordinates":58},[59,60],-113.46871,53.55014,{"lat":60,"lon":59},[63],{"name":64,"role":31,"phone":32,"phoneExt":18,"email":33},"Puneeta Tandon, MD",{"facility":66,"status":41,"city":67,"state":68,"zip":69,"country":45,"countryCode":46,"cosmosGeoPoint":70,"geoPoint":74,"contacts":18},"Gordon and Leslie Diamond Health Care Centre","Vancouver","British Columbia","V5Z 1M9",{"type":48,"coordinates":71},[72,73],-123.11934,49.24966,{"lat":73,"lon":72},{"facility":76,"status":41,"city":77,"state":78,"zip":79,"country":45,"countryCode":46,"cosmosGeoPoint":80,"geoPoint":84,"contacts":18},"London Health Sciences Centre","London","Ontario","N6A 5W9",{"type":48,"coordinates":81},[82,83],-81.23304,42.98339,{"lat":83,"lon":82},{"facility":86,"status":41,"city":87,"state":78,"zip":88,"country":45,"countryCode":46,"cosmosGeoPoint":89,"geoPoint":93,"contacts":18},"Toronto General Hospital - Ajmera Transplant Centre","Toronto","M5G 0A3",{"type":48,"coordinates":90},[91,92],-79.39864,43.70643,{"lat":92,"lon":91},{"facility":95,"status":41,"city":96,"state":97,"zip":98,"country":45,"countryCode":46,"cosmosGeoPoint":99,"geoPoint":103,"contacts":18},"McGill University Health Centre","Montreal","Quebec","H4A3J1",{"type":48,"coordinates":100},[101,102],-73.58781,45.50884,{"lat":102,"lon":101},{"type":105,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100508347","online-prehabilitation-for-patients-awaiting-liver-transplantation-100508347",false,"NCT05899231","Online Prehabilitation for Patients Awaiting Liver Transplantation","OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes","OPAL","Inclusion Criteria:\n\n≥18 years old with cirrhosis (confirmed with transient elastography by FibroScan, histology, or imaging-based assessment with compatible clinical picture), referred for transplant and are assessed to have a high likelihood of being listed according to a preliminary review by hepatologist or are already listed for LT, are pre-frail or frail on the liver frailty index (LFI) or (added August 30, 2024) pre-frail or frail on the TeLeFI (prefrail LFI 3.2-4.3 and frail LFI ≥4.4), have English or French language proficiency, and own an internet-connected device.\n\nExclusion Criteria:\n\n* Listed for living related donor transplantation with expected time on the wait list \\\u003C12 weeks, or model for end-stage liver disease (MELD-Na) Score \\>26 (Justification: time to transplant is very short)\n* Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)\n* Unable to provide informed consent\n* Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation\n* Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit)\n* Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure\n* Transplant indication is cholangiocarcinoma.","ALL","18 Years",{"count":117,"type":118},177,"ESTIMATED","INTERVENTIONAL",[121],"NA","Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition, exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant.\n\nThe proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 177 patients will be recruited from 6 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care.\n\nThe primary outcome of physical function will be evaluated using the FTSST at baseline and 12 weeks (or last timepoint before transplant) assessed virtually or in-person. Secondary outcomes include liver specific physical frailty, aerobic fitness, health-related quality of life (QoL), participant experience and acceptability. Exploratory outcomes include other virtual and in-person physical function measures, covert hepatic encephalopathy (CHE), sarcopenia, malnutrition, adherence, behaviour factors, clinical and post-transplant outcomes. Results will be compared between the intervention and usual care groups.",[124,125,126],"Cirrhosis, Liver","Liver Transplant Surgery","Liver Disease",[128,129,130,131,132,133,134,135,136,137,138,139,140,141],"frailty","transplant","nutrition","exercise","ehealth","application","wellness","prehabilitation","sarcopenia","malnutrition","physical function","digital","virtual","online","2026-04-07",{"date":144,"type":145},"2026-04-08","ACTUAL",{"date":147,"type":145},"2023-07-12",{"date":149,"type":118},"2026-09",{"name":5,"class":6},6]