Prehabilitation Program for Elective Surgery
(PRIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for adults undergoing major elective surgery. The main questions it aims to answer are:
1. Can researchers successfully recruit and retain participants across multiple sites?
2. Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?
Researchers will compare the prehabilitation program to standard preoperative care to see if the intervention is feasible to implement and whether it may help reduce postoperative complications.
Participants will:
* Be randomly assigned to receive either the prehabilitation program or usual care
* Complete questionnaires and physical assessments before and after the intervention
* (For those in the intervention group) Receive exercise, nutrition, and mindfulness guidance, protein supplements, and use the CloudDX virtual care platform to support their activities
Who Is on the Research Team?
Jordan Leitch, MSc, MD, FRCPC
Principal Investigator
Queen's University
Are You a Good Fit for This Trial?
This trial is for adults scheduled to have major elective surgery. Participants should be able to take part in a home-based program and use virtual care tools. People who cannot safely exercise or follow the program may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prehabilitation
Participants in the intervention group receive a home-based, virtually monitored multimodal prehabilitation program including exercise, nutrition, and mindfulness guidance.
Surgery and Immediate Postoperative Care
Participants undergo their scheduled major elective surgery and receive immediate postoperative care.
Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessments of postoperative complications, mortality, and disability.
What Are the Treatments Tested in This Trial?
Interventions
- Virtually Monitored Home-Based Prehabilitation Program
Trial Overview
The study compares a virtually monitored, home-based prehabilitation program—including exercise, nutrition advice, mindfulness training, and protein supplements—to standard pre-surgery care. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm will receive a home-based, virtually monitored multimodal prehabilitation program. The intervention includes aerobic and strength exercise prescriptions, nutritional counseling, mindfulness breathing exercises, and 36 Premier Protein® shakes. Participants will use the CloudDX® virtual care platform via a provided tablet or their own device to support adherence and track progress.
Participants in this arm will receive standard preoperative care as per current clinical practice. They will not receive any structured prehabilitation components during the study period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Queen's University
Lead Sponsor
Ottawa Hospital Research Institute
Collaborator
Kingston Health Sciences Centre
Collaborator
Hamilton Health Sciences Centre
Collaborator
Canadian Anesthesia Research Foundation
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
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