Testing Prehabilitation Programming for liver cirrhosis
Official title: Online Prehabilitation for Patients Awaiting Liver Transplantation
OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes
- 2 groups
- Sites in Calgary, Edmonton and 4 more cities
- Recruiting
Interventions
- Behavioural therapy
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.
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Recruiting
Kaye Edmonton Clinic
Edmonton, Alberta
- Recruiting
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Toronto General Hospital - Ajmera Transplant Centre
Toronto, Ontario
- Recruiting
McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +≥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
- −Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)
- −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)
- −Unable to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Prehabilitation Programming.
Registry label: A: Prehabilitation Group
Group B receives no study treatment and is followed for comparison.
Registry label: B: Usual Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 177 people.
The study is currently expected to finish around September 2026.
The main measurement is taken over: Week 0.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in time to do 5-sit-to-stands from baselineBaselineYour starting measurements, taken before treatment begins.Read more → — measured over Week 0.
Change in time to do 5-sit-to-stands from baseline — measured over Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05899231 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 0.
The study as a whole is currently expected to finish around 2026-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 177 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.