PRehab tO PreparE Living Liver Donors for Enhanced Recovery

NCT05431361 | Completed

• 1 other identifier: 22-5022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.to determine what, if any, intervention or trial modifications are warranted for a Phase III RCT; and,
3. 3.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.

Conditions

Living Donor Liver Transplantation

Keywords

Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Feasibility Outcomes

  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

  12 Weeks

Secondary Outcomes (3)

• Post operative length of stay (LOS)

  12 Weeks

• Surgical and post-operative complications

  12 Weeks

• Hospital readmission

  12 Weeks

Study Arms (2)

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.

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.

Interventions

Prehabilitation OTHER

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.

Also known as: Prehab

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Model Details: randomized 2:1 (intervention:control)

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 24, 2022
• Study Start: August 4, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)