Recruiting

Prehabilitation

Sponsor:

University of Alberta

Code:

NCT05899231

Conditions

Cirrhosis, Liver

Liver Transplant Surgery

Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation Programming

Study Details

Brief summary:

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.

The 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.

The 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.

Conditions

Cirrhosis, Liver

Liver Transplant Surgery

Liver Disease

Study ID

NCT05899231

Start date

Jul 12, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

≥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.

Exclusion Criteria:

  • Listed for living related donor transplantation with expected time on the wait list <12 weeks, or model for end-stage liver disease (MELD-Na) Score >26 (Justification: time to transplant is very short)
  • Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)
  • Unable to provide informed consent
  • Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
  • Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit)
  • Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure
  • Transplant indication is cholangiocarcinoma.

Study Design

Enrollment

177 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prehabilitation Group

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.

no intervention: Usual Care

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.

Interventions

Prehabilitation Programming

12-weeks of online prehabilitation programming including:

1.12 weeks of nutrition programming focused on achieving a guideline- based protein intake of 1.2-1.5 g/kg/day. 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.

2.10 weeks of exercise programming focused on completion of 3 full- body resistance/aerobic exercise sessions weekly (1 or 2 virtual group classes as per patient preference + 1 or 2 pre-recorded home exercise videos).

3.12 weeks of acceptance and commitment therapy based educational videos and online activities focused on reducing stress and anxiety and improving motivation and adherence.

Primary outcome measure

  • Change in time to do 5-sit-to-stands from baseline [ Time Frame: Week 0 ]
  • Change in time to do 5-sit-to-stands from baseline [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Puneeta Tandon

780-492-9844ptandon@ualberta.ca

Margaret McNeely

780-248-1531margie.mcneely@ualberta.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Kaye Edmonton Clinic

Recruiting

Edmonton, Alberta, Canada, T6G1Z1

Contacts

Puneeta Tandon, MD

780-492-9844ptandon@ualberta.ca

Gordon and Leslie Diamond Health Care Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Toronto General Hospital - Ajmera Transplant Centre

Recruiting

Toronto, Ontario, Canada, M5G 0A3

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A3J1

More Information

Sponsor

University of Alberta

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • frailty
  • transplant
  • nutrition
  • exercise
  • ehealth
  • application
  • wellness
  • prehabilitation
  • sarcopenia
  • malnutrition
  • physical function
  • digital
  • virtual
  • online

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-08.