Living Donor Liver TransplantationPROPELLERNCT05431361
PRehab tO PreparE Living Liver Donors for Enhanced Recovery
A study testing Prehabilitation in people with Living Donor Liver Transplantation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
1. to determine if a Phase III RCT of prehab vs usual care for LLDs is feasible (including rates of recruitment, adherence, adverse events, and attrition); 2. to determine what, if any, intervention or trial modifications are warranted for a Phase III RCT; and, 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fluent in English for the purposes of providing informed consent, completing study-related questionnaires, and understanding intervention and other study requirements
- Have a minimum of 28 days prior to scheduled LDLT
Who cannot join
- They plan to be absent for more than 2 weeks of the intervention period
- Their health status changes during the pre-LDLT procedure which results in the loss of LLD candidacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehab to Prepare Living Liver Donors for Enhanced Recovery
- to determine if a Phase III RCT of prehab vs usual care for LLDs is feasible (including rates of recruitment, adherence, adverse events, and attrition);
- to determine what, if any, intervention or trial modifications are warranted for a Phase III RCT; and,
- to explore estimates of efficacy among donor-centered outcomes (e.g., quality of life, physical function, satisfaction with care) that may form the basis for sample size calculations of a Phase III RCT.
Read the detailed description
Living donor liver transplantation (LDLT) is an established treatment for end-stage liver disease.1 Preserving health and quality of life are priorities of care for living liver donors (LLD) as they receive no direct medical benefit from their donation.1,2 Unfortunately, recent research demonstrates that LLDs experience significant postoperative pain, dysfunction, and adverse psychosocial outcomes that may persist up to several years.3-5 Given the risks and postoperative sequalae associated with LDLT, potential LLDs must undergo a comprehensive and interdisciplinary screening and selection process, including a medical history, laboratory assessments, and physical and psychosocial/psychiatric examinations.1 Yet, despite widely established thresholds for organ donation candidacy, research demonstrates that living liver or kidney donors with lower pre-donation physical and mental health (e.g., higher BMI, fatigue, less physical activity, smoking, mood and anxiety disturbance) are at higher risk for worse physical and mental health, and health-related quality of life up to 12 months after donation.6-8 Moreover, some potential donors may lose donation candidacy for a variety of reasons, including changes in health, increasing anxiety and ambivalence related to the donation, or insufficient support.1,9 Strategies aimed at optimizing the mental and physical health for potential LLDs are therefore appropriate for both the minimization of surgical risks and preservation of candidate pools, but also, are in keeping with the priorities of LDLT - that is, preservation of health and quality of life for LLDs.
Over the last fifteen years, prehabilitation (or 'prehab') has emerged and grown as a feasible, safe, and efficacious strategy to improve preoperative health and contribute to reductions in surgical complications and adverse postoperative outcomes. Prehab has been examined in numerous surgical settings, including oncology10, cardiology11,12, and among solid organ transplant recipients.13-16 Prehab research and clinical application have generally focused on high-risk surgical candidates in the interest of efficient resource allocation given the likelihood for clinically meaningful improvements in outcomes (e.g., reduced surgical complications).17-20 To date, living organ donors have not been targeted recipients of prehab given their relatively low surgical risk due to health screening and selection. However, this is at odds with the philosophy of care for living donors (i.e., to protect against adverse effects) and undervalues the decrement in quality of life that many donors endure. Accordingly, research examining the role and effect of prehab for LLDs has important health and ethical implications.
Given that there have been no studies examining the effect of prehab for LLDs, much uncertainty remains about whether LLDs will enroll, adhere, and be retained in the intervention. Further, while we may surmise what the ideal components of prehab may be for LLDs, this has yet to be examined. Finally, there are no studies assessing the feasibility of conducting a large scale randomized controlled trial (RCT) of prehab for LLDs that could help establish sample sizes, recruitment strategies, and intervention and measurement design elements. Thus, in this trial protocol entitled "PRehab tO PreparE Living Liver Donors for Enhanced Recovery" (PROPELLER), we propose a feasibility RCT of prehab vs usual care for LLDs who are scheduled for LDLT.
- Conditions
- Living Donor Liver Transplantation
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Also called Prehab
A Registered Kinesiologist (RKin) will provide the exercise prescription, consisting of 4-5 days of aerobic exercise training and 2-3 days of resistance exercise training of major muscle groups, during a remotely delivered familiarization session using Microsoft Teams. The 60-minute remote program introduction will include a description and demonstration of all of the exercises that will follow the baseline assessment. Patients will be prescribed an individualized exercise program considering: (1) their exercise preferences, (2) their current physical capacity, (3) previous medical history, and (4) presence of underlying comorbidities, mobility, and skeletal fragility concerns [NOTE: the location/impact of a tumour is not applicable for PROPELLER as it was in REB#5901, and is thus not included here]. The participant will have an opportunity to execute the exercises in the remote presence of the RKin who will provide corrective feedback where applicable.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | PREHAB participants will receive a multimodal intervention comprising of exercise, nutrition, and psycho/behavioural/educational support provided by an interprofessional prehab team comprising kinesiologists, dietitians, psychologists, and a previous LLD study partner. To facilitate overall compliance and appropriate adaptation to the home-based intervention components, participants will receive printed material, and a study coordinator will communicate weekly with patients to provide encouragement, monitor adherence, and clarify any questions or concerns. Receives: Other: Prehabilitation |
| Usual Care | No intervention | Usual care participants will be instructed to resume typical lifestyle behaviours until the date of the surgery. To standardize exposure to publicly available resources, usual care participants will receive the 24-Hour Movement Guidelines for Adults,33 Canada's Food Guide,27 a list of stress management resources (website, apps, free reading material), and reference to the Smoker's Helpline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes
- Recruitment success will be measured by the proportion of participants who are randomized divided by the number of identified eligible LLDs. Reasons for non-participation will be collected. The feasibility target is 40%. ii. Adherence will be collected on participants attendance and completion of the interventions prescribed iii. The frequency of drop-out during program participation will be documented including reasons for drop-out. The feasibility target for attrition is equal to or less than 15%. iv. The amount of missing data will be quantified and reported as a feasibility outcome. Data missingness will be reported as the proportion of each outcome measure that is incomplete and per timepoint.
- Any safety or adverse events related to the prehabilitation intervention or study testing will be reported during weekly telephone calls with participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.36
Measured: 12 Weeks
Secondary outcomes (3)
Post operative length of stay (LOS)
Postoperative LOS will be recorded from the participant medical record in days from the time of surgery until hospital discharge, abstracted from the medical record.
ii. Surgical and post-operative complications Complications, including mortality, will be abstracted from the medical record and follow the Clavien-Dindo classification.37 38
iii. Hospital Readmission Any health event that requires readmission will also be documented. This will be recorded during hospitalization and up to 12 weeks postoperatively, derived from the medical record.
Measured: 12 Weeks
Surgical and post-operative complications
Complications, including mortality, will be abstracted from the medical record and follow the Clavien-Dindo classification.
Measured: 12 Weeks
Hospital readmission
Any health event that requires readmission will also be documented. This will be recorded during hospitalization and up to 12 weeks postoperatively, derived from the medical record.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start4 Aug 2022
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 2:1 (intervention:control)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Santa Mina, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431361
- Sponsor's protocol ID
- 22-5022
- Acronym
- PROPELLER
- Status last verified
- Mar 2026
- First submitted
- 15 Jun 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehab to Prepare Living Liver Donors for Enhanced Recovery
- ClinicalTrials.gov ID
- NCT05431361
- Acronym / sponsor ID
- PROPELLER / 22-5022
- Conditions
- Living Donor Liver Transplantation
- Keywords
- Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 24 Jun 2022 (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.
- to determine if a Phase III RCT of prehab vs usual care for LLDs is feasible (including rates of recruitment, adherence, adverse events, and attrition);
- to determine what, if any, intervention or trial modifications are warranted for a Phase III RCT; and,
- to explore estimates of efficacy among donor-centered outcomes (e.g., quality of life, physical function, satisfaction with care) that may form the basis for sample size calculations of a Phase III RCT.
Detailed description
Living donor liver transplantation (LDLT) is an established treatment for end-stage liver disease.1 Preserving health and quality of life are priorities of care for living liver donors (LLD) as they receive no direct medical benefit from their donation.1,2 Unfortunately, recent research demonstrates that LLDs experience significant postoperative pain, dysfunction, and adverse psychosocial outcomes that may persist up to several years.3-5 Given the risks and postoperative sequalae associated with LDLT, potential LLDs must undergo a comprehensive and interdisciplinary screening and selection process, including a medical history, laboratory assessments, and physical and psychosocial/psychiatric examinations.1 Yet, despite widely established thresholds for organ donation candidacy, research demonstrates that living liver or kidney donors with lower pre-donation physical and mental health (e.g., higher BMI, fatigue, less physical activity, smoking, mood and anxiety disturbance) are at higher risk for worse physical and mental health, and health-related quality of life up to 12 months after donation.6-8 Moreover, some potential donors may lose donation candidacy for a variety of reasons, including changes in health, increasing anxiety and ambivalence related to the donation, or insufficient support.1,9 Strategies aimed at optimizing the mental and physical health for potential LLDs are therefore appropriate for both the minimization of surgical risks and preservation of candidate pools, but also, are in keeping with the priorities of LDLT - that is, preservation of health and quality of life for LLDs.
Over the last fifteen years, prehabilitation (or 'prehab') has emerged and grown as a feasible, safe, and efficacious strategy to improve preoperative health and contribute to reductions in surgical complications and adverse postoperative outcomes. Prehab has been examined in numerous surgical settings, including oncology10, cardiology11,12, and among solid organ transplant recipients.13-16 Prehab research and clinical application have generally focused on high-risk surgical candidates in the interest of efficient resource allocation given the likelihood for clinically meaningful improvements in outcomes (e.g., reduced surgical complications).17-20 To date, living organ donors have not been targeted recipients of prehab given their relatively low surgical risk due to health screening and selection. However, this is at odds with the philosophy of care for living donors (i.e., to protect against adverse effects) and undervalues the decrement in quality of life that many donors endure. Accordingly, research examining the role and effect of prehab for LLDs has important health and ethical implications.
Given that there have been no studies examining the effect of prehab for LLDs, much uncertainty remains about whether LLDs will enroll, adhere, and be retained in the intervention. Further, while we may surmise what the ideal components of prehab may be for LLDs, this has yet to be examined. Finally, there are no studies assessing the feasibility of conducting a large scale randomized controlled trial (RCT) of prehab for LLDs that could help establish sample sizes, recruitment strategies, and intervention and measurement design elements. Thus, in this trial protocol entitled "PRehab tO PreparE Living Liver Donors for Enhanced Recovery" (PROPELLER), we propose a feasibility RCT of prehab vs usual care for LLDs who are scheduled for LDLT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 2:1 (intervention:control)
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: PrehabilitationPREHAB participants will receive a multimodal intervention comprising of exercise, nutrition, and psycho/behavioural/educational support provided by an interprofessional prehab team comprising kinesiologists, dietitians, psychologists, and a previous LLD study partner. To facilitate overall compliance and appropriate adaptation to the home-based intervention components, participants will receive printed material, and a study coordinator will communicate weekly with patients to provide encouragement, monitor adherence, and clarify any questions or concerns. |
| Usual Care | No intervention | –Usual care participants will be instructed to resume typical lifestyle behaviours until the date of the surgery. To standardize exposure to publicly available resources, usual care participants will receive the 24-Hour Movement Guidelines for Adults,33 Canada's Food Guide,27 a list of stress management resources (website, apps, free reading material), and reference to the Smoker's Helpline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fluent in English for the purposes of providing informed consent, completing study-related questionnaires, and understanding intervention and other study requirements
- Have a minimum of 28 days prior to scheduled LDLT
Key exclusion criteria (2 listed)
- They plan to be absent for more than 2 weeks of the intervention period
- Their health status changes during the pre-LDLT procedure which results in the loss of LLD candidacy
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 |
|---|---|---|
| PrehabilitationAlso: PrehabA Registered Kinesiologist (RKin) will provide the exercise prescription, consisting of 4-5 days of aerobic exercise training and 2-3 days of resistance exercise training of major muscle groups, during a remotely delivered familiarization session using Microsoft Teams. The 60-minute remote program introduction will include a description and demonstration of all of the exercises that will follow the baseline assessment. Patients will be prescribed an individualized exercise program considering: (1) their exercise preferences, (2) their current physical capacity, (3) previous medical history, and (4) presence of underlying comorbidities, mobility, and skeletal fragility concerns [NOTE: the location/impact of a tumour is not applicable for PROPELLER as it was in REB#5901, and is thus not included here]. The participant will have an opportunity to execute the exercises in the remote presence of the RKin who will provide corrective feedback where applicable. | Other | Prehabilitation |
Primary outcome
Feasibility Outcomes
Time frame: 12 Weeks
i. Recruitment success will be measured by the proportion of participants who are randomized divided by the number of identified eligible LLDs. Reasons for non-participation will be collected. The feasibility target is 40%. ii. Adherence will be collected on participants attendance and completion of the interventions prescribed iii. The frequency of drop-out during program participation will be documented including reasons for drop-out. The feasibility target for attrition is equal to or less than 15%. iv. The amount of missing data will be quantified and reported as a feasibility outcome. Data missingness will be reported as the proportion of each outcome measure that is incomplete and per timepoint. v. Any safety or adverse events related to the prehabilitation intervention or study testing will be reported during weekly telephone calls with participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.36
3 secondary outcomes
Post operative length of stay (LOS)
Time frame: 12 Weeks
Surgical and post-operative complications
Time frame: 12 Weeks
Hospital readmission
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Living Donor Liver Transplantation, run by University Health Network, Toronto at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility Outcomes (time frame: 12 Weeks). 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 12 Mar 2026.