Prehabilitation Program for Elective Surgery

(PRIME Trial)

Not yet recruiting at 2 trial locations
RP
DD
Overseen ByDeborah DuMerton
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Queen's University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

JL

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

More than 3 weeks from the date of scheduled operation
I am scheduled for major surgery inside my chest, abdomen, or bones.
I am 18 years old or older.

Exclusion Criteria

Patients who are pregnant
Presence of physical, cognitive, or psychological impairment
I am not able or willing to sign a consent form.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants in the intervention group receive a home-based, virtually monitored multimodal prehabilitation program including exercise, nutrition, and mindfulness guidance.

3 weeks
Virtual monitoring via CloudDX platform

Surgery and Immediate Postoperative Care

Participants undergo their scheduled major elective surgery and receive immediate postoperative care.

1 week

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of postoperative complications, mortality, and disability.

30 days
In-person and virtual assessments

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

Group I: Prehabilitation ProgramExperimental Treatment1 Intervention
Group II: Preoperative Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials
382
Recruited
122,000+

Ottawa Hospital Research Institute

Collaborator

Trials
585
Recruited
3,283,000+

Kingston Health Sciences Centre

Collaborator

Trials
32
Recruited
34,400+

Hamilton Health Sciences Centre

Collaborator

Trials
1
Recruited
2,000+

Canadian Anesthesia Research Foundation

Collaborator

Trials
1
Recruited
150+

St. Joseph's Healthcare Hamilton

Collaborator

Trials
203
Recruited
26,900+