Cirrhosis, LiverOPALNCT05899231
Online Prehabilitation for Patients Awaiting Liver Transplantation
A study testing Prehabilitation Programming in people with Cirrhosis, Liver and Liver Transplant Surgery, run by University of Alberta at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Liver Transplant Surgery, Liver Disease
- What is being tested?
- Prehabilitation Programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 6 sitesCanada
- Study dates
- 12 Jul 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Kaye Edmonton Clinic
Edmonton, Alberta, T6G1Z1
London Health Sciences Centre
London, Ontario, N6A 5W9
McGill University Health Centre
Montreal, Quebec, H4A3J1
Toronto General Hospital - Ajmera Transplant Centre
Toronto, Ontario, M5G 0A3
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the 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.
- 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.
- 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
- 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.
- 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.
- Conditions
- Cirrhosis, Liver, Liver Transplant Surgery, Liver Disease
- Being tested
- Prehabilitation Programming
- Keywords
- frailty, transplant, nutrition, exercise, ehealth, application, wellness, prehabilitation, sarcopenia, malnutrition, physical function, digital, virtual, online
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Frailty, Motor Activity, Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgrammingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 12
Secondary outcomes (9)
Change in liver frailty index from baseline
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.
Measured: Week 0
Change in liver frailty index from baseline
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.
Measured: Week 12
Changes in virtual physical function testing over time (2-min step test)
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
Measured: Week 0
Changes in virtual physical function testing over time (2-min step test)
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
Measured: Week 12
Change in health-related quality of life from baseline (CLDQ)
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.
Measured: Week 0
Change in health-related quality of life from baseline (CLDQ)
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.
Measured: Week 12
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
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.
Measured: Week 0
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
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.
Measured: Week 12
Qualitative Acceptability Data
Inductive analysis of post-trial semi-structured interviews/focus groups with participants
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start12 Jul 2023
- Primary completion28 Aug 2026
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Puneeta Tandon, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899231
- Sponsor's protocol ID
- Pro00125367
- Acronym
- OPAL
- Status last verified
- Nov 2026
- First submitted
- 15 May 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes
- ClinicalTrials.gov ID
- NCT05899231
- Acronym / sponsor ID
- OPAL / Pro00125367
- Conditions
- Cirrhosis, Liver, Liver Transplant Surgery, Liver Disease
- Keywords
- frailty, transplant, nutrition, exercise, ehealth, application, wellness, prehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Group | Experimental | Behavioral: Prehabilitation ProgrammingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation Programming12-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. | Behavioural | Prehabilitation Group |
Primary outcome
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
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
9 secondary outcomes
Change in liver frailty index from baseline
Time frame: Week 0
Change in liver frailty index from baseline
Time frame: Week 12
Changes in virtual physical function testing over time (2-min step test)
Time frame: Week 0
Changes in virtual physical function testing over time (2-min step test)
Time frame: Week 12
Change in health-related quality of life from baseline (CLDQ)
Time frame: Week 0
Change in health-related quality of life from baseline (CLDQ)
Time frame: Week 12
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time frame: Week 0
Change in health-related quality of life from baseline (EQ5D5L and EQVAS)
Time frame: Week 12
Qualitative Acceptability Data
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puneeta Tandon principal investigator
University of Alberta
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Programming in people with Cirrhosis, Liver and Liver Transplant Surgery, run by University of Alberta at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to do 5-sit-to-stands from baseline (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.