Online Prehabilitation for Patients Awaiting Liver Transplantation

NCT05899231 | Recruiting

• 1 other identifier: Pro00125367
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 6

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

Liver Disease; Cirrhosis, Liver; Liver Transplant Surgery

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in time to do 5-sit-to-stands from baseline

  A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform

  Week 0

• Change in time to do 5-sit-to-stands from baseline

  A time to complete 5 chair stands of \>15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform

  Week 12

Secondary Outcomes (9)

• Change in liver frailty index from baseline

  Week 0

• Change in liver frailty index from baseline

  Week 12

• Changes in virtual physical function testing over time (2-min step test)

  Week 0

• Changes in virtual physical function testing over time (2-min step test)

  Week 12

• Change in health-related quality of life from baseline (CLDQ)

  Week 0

Other Outcomes (47)

• Change in time to do 5-sit-to-stands from baseline

  Week 8

• Change in sarcopenia from baseline

  Week 0

• Change in sarcopenia from baseline

  Week 12

Study Arms (2)

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.

Behavioral: Prehabilitation Programming

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.

Interventions

Prehabilitation Programming BEHAVIORAL

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.

Prehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (6)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Kaye Edmonton Clinic

Edmonton, Alberta, T6G1Z1, Canada

RECRUITING

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Toronto General Hospital - Ajmera Transplant Centre

Toronto, Ontario, M5G 0A3, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases; Frailty; Motor Activity; Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Puneeta Tandon

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puneeta Tandon

CONTACT

780-492-9844; ptandon@ualberta.ca

Margaret McNeely

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 12, 2023
• Study Start: July 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)