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Prehabilitation for Liver Transplant Donors (PROPELLER Trial)
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Plan to be absent for more than 2 weeks of the intervention period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a prehab program can help living liver donors by improving their health before surgery. The program includes exercises, nutritional advice, and mental health support. The goal is to reduce pain and improve recovery after they donate their liver.
Who is the study for?
This trial is for English-speaking individuals scheduled for a living liver donation (LLD) with at least 28 days before their procedure. It's not suitable for those who'll be away for more than two weeks during the study or if their health status changes, making them ineligible to donate.
What is being tested?
The study is testing 'prehabilitation'—a preparatory care program—to see if it can improve recovery after liver donation. The goal is to check how feasible this approach is by looking at participant recruitment, adherence to the program, adverse events, and dropout rates.
What are the potential side effects?
Since this trial involves a prehabilitation program rather than medication, side effects may include discomfort or fatigue from physical exercises included in the regimen. However, specific side effects will depend on the details of the prehabilitation activities.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I will not be away for more than 2 weeks during the treatment period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility Outcomes
Secondary study objectives
Hospital readmission
Post operative length of stay (LOS)
Surgical and post-operative complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PrehabilitationExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 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.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
503,142 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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