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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

PROPELLER Trial Summary

This trial is to see if it's feasible to do a Phase III trial of pre-habilitation (getting in shape before surgery) vs. usual care for people with limb-length discrepancies (LLDs), and to explore if the trial needs any modifications.

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.Check my eligibility

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.See study design

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.

PROPELLER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility Outcomes

Secondary outcome measures

Hospital readmission

Post operative length of stay (LOS)

Surgical and post-operative complications

PROPELLER 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,475 Previous Clinical Trials

485,060 Total Patients Enrolled

Media Library

Prehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05431361 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently being administered the study treatment?

"Affirmative. Clinicaltrials.gov reveals that this research is actively seeking participants, having been posted on May 4th 2022 and updated December 1st 2022. Thirty enrollees are needed across one centre for the study to begin collecting data."

Answered by AI

Are there still openings available for participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively recruiting participants; the trial was initially made public on May 4th 2022 and has recently been updated on December 1st of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRehab tO PreparE Living Liver Donors for Enhanced Recovery

Daniel Santa Mina 2022. "PRehab tO PreparE Living Liver Donors for Enhanced Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05431361.

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