OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
Other Locations
Canada
Foothills Medical Centre
RECRUITING
Calgary
Kaye Edmonton Clinic
RECRUITING
Edmonton
London Health Sciences Centre
RECRUITING
London
McGill University Health Centre
RECRUITING
Montreal
Toronto General Hospital - Ajmera Transplant Centre
RECRUITING
Toronto
Gordon and Leslie Diamond Health Care Centre
RECRUITING
Vancouver
Contact Information
Primary
Puneeta Tandon
ptandon@ualberta.ca
780-492-9844
Backup
Margaret McNeely
margie.mcneely@ualberta.ca
780-248-1531
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2026-03
Participants
Target number of participants: 177
Treatments
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.
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov

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