Online Prehabilitation for Patients Awaiting Liver Transplantation (OPAL)

April 7, 2026 updated by: University of Alberta

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multi-centre randomized controlled trial (RCT) will be completed across the six major LT programs in Canada: Vancouver, Edmonton, Calgary, Toronto, London, and Montreal.

Participants involved in this study will be LT transplant candidates with cirrhosis who are receiving care at one of the six participating LT programs.

Participants will be assessed for eligibility, provided informed signed consent, complete baseline testing and then be randomized to the prehabilitation arm or usual care. Participants will be randomized in a 2:1 ratio between groups.

Prehabilitation Arm:

The 12 week prehabilitation program includes exercise, nutrition and psychological components that is accessed through the online digital web platform.

  • The nutrition program includes a nutritional assessment, provision of a daily protein intake target (1.2-1.5 g/kg/day), online group sessions, and follow ups. Participants will also be provided with a clinically tested whey protein powder supplement with dosage based on their malnutrition scoring done at baseline. Follow ups will also be provided based on malnutrition scoring done at baseline.
  • The exercise program includes an exercise assessment, follow along exercise videos, and weekly virtual live exercise sessions. The exercise specialist will advise one of three levels of exercise programming for each participant. Participants will be advised to complete 3 exercise sessions weekly from a combination of virtual group sessions and follow along videos and to participate in planned aerobic activity as much as possible.
  • The weekly acceptance and commitment therapy based educational videos focus on reducing stress and anxiety and improving motivation and adherence.

Control/Usual Care Arm:

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. A short questionnaire will be sent to control participants every 4 weeks to track changes in physical activity.

Post-Transplant follow-up In the subgroup of patients who undergo LT, the same in-person and virtual testing will be carried out at 12 weeks post-transplant (timing may vary due to site clinic flow)

Data Collection Plan

Sample size calculations are based on the primary outcome (the chair stand test: time to complete 5 sit-to-stands) using individual data from our local exercise study in cirrhosis (n=59), plus our sit-to-stand data from our study of 694 patients. After accounting for lack of trial completion, loss to follow up, the total sample size is 177, with 59 participants in the control and 118 in the intervention arm.

  1. Quantitative outcomes: Baseline and primary/secondary/exploratory outcome data will be collected with in-person and/or virtual visits at baseline, week 12 (end of trial) and 12 weeks post-transplant (in the subgroup of patients who undergo LT). Charts will be reviewed for information on death, hospitalization, ambulatory care visits, medications and transplantation for up to 2 years after randomization in all participants. Dietary intake data (24-hour recall) may be collected using third party software.
  2. Qualitative data: Interviews/Focus groups will be conducted at the end of the study in a virtual format. Participation in the interviews/focus groups will be optional.

Types of analyses

  1. Quantitative outcomes: Baseline demographic and clinical characteristics will be compared between groups to identify differences that may exist despite randomization. Continuous variables will be screened for assumptions of normality, and descriptive analyses will be presented for participant demographics, medical and outcome variables. Sex will be used in subgroup analysis of primary and secondary outcomes. It will also be a covariate for exploratory analysis in corresponding models. All analyses will adhere to the intention-to-treat principle.
  2. Qualitative data: Qualitative data will be analyzed inductively following a theoretical thematic approach. Data will be coded, with codes combined into larger categories and theme, with the goal of highlighting participant experiences and acceptability (barriers, facilitators) of the OPAL platform and intervention. Data collection and analysis will occur concurrently in order to enable refinement of interview/focus guide questions and deeper exploration of emerging themes.

Primary outcome: The primary outcome (sit to stand test; time to do 5 sit-to-stands) will be analyzed by linear mixed models with random effects, adjusted for baseline score as a covariate. Sites will be entered as random effects.

Secondary/exploratory outcomes: (1) Quantitative outcomes: Similar types of models will be used for continuous secondary/exploratory outcomes. To examine predictors of exercise and nutrition adherence (e.g. COM-B results), generalized linear models with binary outcome will be employed. To evaluate the potential effect of selected demographic variables on outcomes, as an exploratory analysis, models will be adjusted for clinically significant variables (e.g. sex, gender, digital technology proficiency). Results will be primarily descriptive. Exploratory per-protocol analysis will be performed, and the results will be presented if substantial differences are found between this group and the intention-to-treat group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T6G1Z1
        • Recruiting
        • Kaye Edmonton Clinic
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Gordon and Leslie Diamond Health Care Centre
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 0A3
        • Recruiting
        • Toronto General Hospital - Ajmera Transplant Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Recruiting
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in time to do 5-sit-to-stands from baseline
Time Frame: Week 0
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
Time Frame: Week 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life from baseline (CLDQ)
Time Frame: Week 0

The disease-specific Chronic Liver Disease Questionnaire (CLDQ) is validated in cirrhosis.

Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7, with higher scores indicating a minimum frequency of symptoms and hence a better HRQOL.
Week 0
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time Frame: Week 0

The EuroQoL 5-D-5L and visual analog scale (EQ-VAS) are generic tools also validated in LT candidates and recipients.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Week 0
Change in health-related quality of life from baseline (CLDQ)
Time Frame: Week 12

The disease-specific Chronic Liver Disease Questionnaire (CLDQ) is validated in cirrhosis.

Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7, with higher scores indicating a minimum frequency of symptoms and hence a better HRQOL.
Week 12
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time Frame: Week 12

The EuroQoL 5-D-5L and visual analog scale (EQ-VAS) are generic tools also validated in LT candidates and recipients.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Week 12
Changes in virtual physical function testing over time (2-min step test)
Time Frame: Week 12

The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes.

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 12
Qualitative Acceptability Data
Time Frame: Week 12
Inductive analysis of post-trial semi-structured interviews/focus groups with participants
Week 12
Change in liver frailty index from baseline
Time Frame: Week 0

Liver frailty will be assessed with a cirrhosis-specific tool. The in-person LFI which includes grip strength, chair stand and balance testing, or the virtual TeLeFI which includes virtual FTSST, three stance balance test, and selected questions from validated surveys. The LFI is an independent predictor of waitlist mortality and hospitalization.

The LFI score can be calculated using an online calculator (available at http://liverfrailtyindex.ucsf.edu), with patient physical frailty categorized as robust, prefrail, and frail according to their index (index < 3.2, robust; 3.2-4.5, prefrail; and >4.5, frail).

Higher scores mean a worse outcome.
Week 0
Change in liver frailty index from baseline
Time Frame: Week 12

Liver frailty will be assessed with a cirrhosis-specific tool. The in-person LFI which includes grip strength, chair stand and balance testing, or the virtual TeLeFI which includes virtual FTSST, three stance balance test, and selected questions from validated surveys. The LFI is an independent predictor of waitlist mortality and hospitalization.

The LFI score can be calculated using an online calculator (available at http://liverfrailtyindex.ucsf.edu), with patient physical frailty categorized as robust, prefrail, and frail according to their index (index < 3.2, robust; 3.2-4.5, prefrail; and >4.5, frail).

Higher scores mean a worse outcome.
Week 12
Changes in virtual physical function testing over time (2-min step test)
Time Frame: Week 0

The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes.

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 0

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in distance in the 6 minute walk test from baseline
Time Frame: Week 0
6MWT distance correlates with waitlist mortality and QoL and is recommended by the American Society of Transplantation. It is associated with protein intake, activity level and physical function/ frailty.
Week 0
Change in distance in the 6 minute walk test from baseline
Time Frame: Week 12
6MWT distance correlates with waitlist mortality and QoL and is recommended by the American Society of Transplantation. It is associated with protein intake, activity level and physical function/ frailty.
Week 12
Change in covert hepatic encephalopathy from baseline
Time Frame: Week 0
The EncephalApp Stroop (Stroop) test is a reliable, easy-to-use diagnostic test for CHE. It evaluates psychomotor speed and cognitive flexibility.
Week 0
Change in covert hepatic encephalopathy from baseline
Time Frame: Week 12
The EncephalApp Stroop (Stroop) test is a reliable, easy-to-use diagnostic test for CHE. It evaluates psychomotor speed and cognitive flexibility.
Week 12
Change in health-related quality of life from baseline (CLDQ)
Time Frame: Week 8

The disease-specific Chronic Liver Disease Questionnaire (CLDQ) is validated in cirrhosis.

Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7, with higher scores indicating a minimum frequency of symptoms and hence a better HRQOL.
Week 8
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time Frame: Week 8

The EuroQoL 5-D-5L and visual analog scale (EQ-VAS) are generic tools also validated in LT candidates and recipients.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Week 8
Change in 6-item COM-B scale over time during intervention
Time Frame: Week 4
Perceived capability, opportunity, and motivation will be assessed over the trial period to understand how the COM-B impacts adherence. Each item is scaled (0 [strongly disagree] to 7 [strongly agree]) and 3 subscores are computed. A higher score means higher perceived capability, opportunity, and motivation
Week 4
Change in 6-item COM-B scale over time during intervention
Time Frame: Week 8
Perceived capability, opportunity, and motivation will be assessed over the trial period to understand how the COM-B impacts adherence. Each item is scaled (0 [strongly disagree] to 7 [strongly agree]) and 3 subscores are computed. A higher score means higher perceived capability, opportunity, and motivation
Week 8
Change in 6-item COM-B scale over time during intervention
Time Frame: Week 12
Perceived capability, opportunity, and motivation will be assessed over the trial period to understand how the COM-B impacts adherence. Each item is scaled (0 [strongly disagree] to 7 [strongly agree]) and 3 subscores are computed. A higher score means higher perceived capability, opportunity, and motivation.
Week 12
Change in sarcopenia from baseline
Time Frame: Week 0
Calf circumference is a simple measure for appendicular skeletal muscle and predicting sarcopenia
Week 0
Change in sarcopenia from baseline
Time Frame: Week 12
Calf circumference is a simple measure for appendicular skeletal muscle and predicting sarcopenia
Week 12
Changes in virtual physical function testing over time (Single leg balance test)
Time Frame: Week 8

The single leg balance test is used to assess static postural and balance control. The test assesses the length of time the subject can maintain their balance

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 8
Changes in virtual physical function testing over time (2-min step test)
Time Frame: Week 8

The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes.

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 8
Changes in virtual physical function testing over time (Single leg balance test)
Time Frame: Week 12

The single leg balance test is used to assess static postural and balance control. The test assesses the length of time the subject can maintain their balance

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 12
Number of participants who died during the 12 week trial
Time Frame: Week 12
Death will be collected through chart review
Week 12
Number of hospitalizations and ambulatory clinic visits during the 12 week trial
Time Frame: Week 12
Hospitalizations and ambulatory clinic visits will be collected through chart review
Week 12
Number of participants who were transplanted during the 12 week trial
Time Frame: Week 12
Data on transplantations occurring during the trial will be collected through chart review
Week 12
Number of participants who died during the 2 years post-study completion
Time Frame: 2 years post-study completion
Death will be collected through chart review. Consent will be obtained to extend this to 2 years of extended follow-up for all participants and to link to administrative data-repositories for follow-on research.
2 years post-study completion
Number of hospitalizations and ambulatory clinic visits during the 2 years post-study completion
Time Frame: 2 years post-study completion
Hospitalizations and ambulatory clinic visits will be collected through chart review. Consent will be obtained to extend this to 2 years of extended follow-up for all participants and to link to administrative data-repositories for follow-on research.
2 years post-study completion
Number of participants who were transplanted during the 2 years post-study completion
Time Frame: 2 years post-study completion
Data on transplantations occurring during the trial will be collected through chart review. Consent will be obtained to extend this to 2 years of extended follow-up for all participants and to link to administrative data-repositories for follow-on research.
2 years post-study completion
Economic Evaluation
Time Frame: Week 12
Healthcare access and hospital usage will be collected through patient survey.
Week 12
Total Length of stay at time of transplant
Time Frame: Post-transplant up to 3 months of the trial data collection period
In participants transplanted within 3 months of the end of the trial data collection period, we will ascertain total length of stay at time of transplant
Post-transplant up to 3 months of the trial data collection period
Intensive care unit length of stay at time of post transplant
Time Frame: Post-transplant up to 3 months of the trial data collection period
In participants transplanted within 3 months of the end of the trial data collection period, we will ascertain intensive care unit length of stay
Post-transplant up to 3 months of the trial data collection period
Days of mechanical ventilation at time of post transplant
Time Frame: Post-transplant up to 3 months of the trial data collection period
In participants transplanted within 3 months of the end of the trial data collection period, we will ascertain days of mechanical ventilation
Post-transplant up to 3 months of the trial data collection period
Discharge location from hospital at time of transplant
Time Frame: Post-transplant up to 3 months of the trial data collection period
In participants transplanted within 3 months of the end of the trial data collection period, we will ascertain discharge home from hospital (versus rehabilitation, nursing home or other institutional location)
Post-transplant up to 3 months of the trial data collection period
Readmissions within 30 days at time of transplant
Time Frame: Post-transplant up to 3 months of the trial data collection period
In participants transplanted within 3 months of the end of the trial data collection period, we will ascertain any readmissions within 30 days.
Post-transplant up to 3 months of the trial data collection period
Malnutrition
Time Frame: Week 0

The Patient-Generated Subjective Global Assessment (PG-SGA) is an instrument for assessment of nutrition status in patients with cancer and other diseases. It contains both a patient and a practitioner section. A higher score means worse outcomes.

The numerical PG-SGA score provides professionals with clearer guidelines as to the level of medical nutrition therapy needed in a given case, while the A, B, or C rating provides an overall picture of a patient's current status. (A = well nourished, B = moderately malnourished or suspected malnutrition and C = severely malnourished).
Week 0
Adverse events
Time Frame: Week 12
Major: death or hospitalization for an event occurring during or up to 3 h after exercise; cardiovascular events (stroke, myocardial infarction); permanent disability; angina, syncope, arrhythmia; variceal bleeding. Minor: hypoglycemia, hyper- or hypotension requiring medical attention, musculoskeletal injury or fall.
Week 12
Changes in health care provider support from baseline
Time Frame: Week 0
Chart review will record days of enteral or parenteral nutrition provided during hospitalization or as an outpatient and will also record exposure to the number of non-intervention digital platform based exercise sessions attended through to end of extended follow-up.
Week 0
Changes in physical activity levels from baseline
Time Frame: Week 0
Participants will be asked to journal about the amount of exercise they take part in over the course of the 12 week trial and for as long as possible into the extended follow-up period as they are willing to.
Week 0
Changes in health care provider support from baseline
Time Frame: Week 4
Chart review will record days of enteral or parenteral nutrition provided during hospitalization or as an outpatient and will also record exposure to the number of non-intervention digital platform based exercise sessions attended through to end of extended follow-up.
Week 4
Changes in physical activity levels from baseline
Time Frame: Week 4
Participants will be asked to journal about the amount of exercise they take part in over the course of the 12 week trial and for as long as possible into the extended follow-up period as they are willing to.
Week 4
Changes in health care provider support from baseline
Time Frame: Week 8
Chart review will record days of enteral or parenteral nutrition provided during hospitalization or as an outpatient and will also record exposure to the number of non-intervention digital platform based exercise sessions attended through to end of extended follow-up.
Week 8
Changes in physical activity levels from baseline
Time Frame: Week 8
Participants will be asked to journal about the amount of exercise they take part in over the course of the 12 week trial and for as long as possible into the extended follow-up period as they are willing to.
Week 8
Changes in health care provider support from baseline
Time Frame: Week 12
Chart review will record days of enteral or parenteral nutrition provided during hospitalization or as an outpatient and will also record exposure to the number of non-intervention digital platform based exercise sessions attended through to end of extended follow-up.
Week 12
Changes in physical activity levels from baseline
Time Frame: Week 12
Participants will be asked to journal about the amount of exercise they take part in over the course of the 12 week trial and for as long as possible into the extended follow-up period as they are willing to.
Week 12
Changes in functional status from baseline
Time Frame: Week 0
The TeLeFI assesses frailty and functional status virtually via phone and/or video capability without specialized equipment to identify patients who may be at risk of frailty as defined by the in-person LFI
Week 0
Changes in functional status from baseline
Time Frame: Week 8
The TeLeFI assesses frailty and functional status virtually via phone and/or video capability without specialized equipment to identify patients who may be at risk of frailty as defined by the in-person LFI
Week 8
Changes in functional status from baseline
Time Frame: Week 12
The TeLeFI assesses frailty and functional status virtually via phone and/or video capability without specialized equipment to identify patients who may be at risk of frailty as defined by the in-person LFI
Week 12
Change in time to do 5-sit-to-stands from baseline
Time Frame: Week 8

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

Completed at week 8 to account for the possibility of transplantation or loss-to-follow-up before the end of the 12 weeks.
Week 8
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time Frame: Post-transplant (12 weeks after transplant date)

The EuroQoL 5-D-5L and visual analog scale (EQ-VAS) are generic tools also validated in LT candidates and recipients.

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Post-transplant (12 weeks after transplant date)
Change in health-related quality of life from baseline (CLDQ)
Time Frame: Post-transplant (12 weeks after transplant date)

The disease-specific Chronic Liver Disease Questionnaire (CLDQ) is validated in cirrhosis.

Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7, with higher scores indicating a minimum frequency of symptoms and hence a better HRQOL.
Post-transplant (12 weeks after transplant date)
Changes in virtual physical function testing over time (Single leg balance test)
Time Frame: Week 0

The single leg balance test is used to assess static postural and balance control. The test assesses the length of time the subject can maintain their balance

The literature supports good correlation of this virtual measure when compared to in-person testing
Week 0
Changes in virtual physical function testing over time (Single leg balance test)
Time Frame: Post-transplant (12 weeks after transplant date)

The single leg balance test is used to assess static postural and balance control. The test assesses the length of time the subject can maintain their balance

The literature supports good correlation of this virtual measure when compared to in-person testing
Post-transplant (12 weeks after transplant date)
Changes in virtual physical function testing over time (2-min step test)
Time Frame: Post-transplant (12 weeks after transplant date)

The 2-min step test is used to assess aerobic endurance and functional fitness. The subject marches in place for two minutes.

The literature supports good correlation of this virtual measure when compared to in-person testing
Post-transplant (12 weeks after transplant date)
Malnutrition
Time Frame: Week 12

The Patient-Generated Subjective Global Assessment (PG-SGA) is an instrument for assessment of nutrition status in patients with cancer and other diseases. It contains both a patient and a practitioner section. A higher score means worse outcomes.

The numerical PG-SGA score provides professionals with clearer guidelines as to the level of medical nutrition therapy needed in a given case, while the A, B, or C rating provides an overall picture of a patient's current status. (A = well nourished, B = moderately malnourished or suspected malnutrition and C = severely malnourished).
Week 12
Adherence to prehabilitation program goals
Time Frame: Week 12
(i) 70% adherence to target protein intake and protein powder supplementation (assessed by dietary intake, nutrition check ins, platform metrics and monthly nutrition questionnaires), (ii) 70% adherence to exercise sessions (assessed by attendance, check ins, platform metrics) excluding study weeks with interruptions to programming due to health related issues (e.g. transplant dry runs, hospital admissions as these are common in patients awaiting LT)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Puneeta Tandon, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00125367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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Locations

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