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?

This trial explores whether a home-based program focused on exercise, nutrition, and mindfulness can effectively prepare patients for major surgeries. Researchers aim to determine if participants will adhere to the program and if it could potentially reduce post-surgery complications. Participants will either follow this new virtually monitored home-based prehabilitation program or continue with standard pre-surgery care to compare outcomes. This trial suits adults scheduled for major elective surgeries, such as those involving the chest, abdomen, or bones, who have more than three weeks before their surgery date. As an unphased trial, it offers a unique opportunity to contribute to innovative pre-surgery care research that could enhance recovery and outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for adults undergoing major elective surgery?

Research has shown that home-based prehabilitation programs, monitored virtually, are generally easy for participants to handle. These programs include exercise, nutrition advice, and mindfulness activities, and studies have found no major safety issues. For example, one study on a similar program reported no significant negative effects, indicating safety for most people.

Other research has demonstrated that home-based prehabilitation is safe for frail individuals before major surgeries, which is promising for its use with different patient groups. These findings suggest that the program is unlikely to cause harm and may even help people prepare for surgery by improving their physical and mental health.12345

Why are researchers excited about this trial?

Researchers are excited about the virtually monitored home-based prehabilitation program because it offers a comprehensive approach to preparing for elective surgery, unlike the standard preoperative care that often lacks structured prehabilitation. This program is unique because it combines aerobic and strength exercises, nutritional counseling, and mindfulness breathing exercises, all while being supported virtually through the CloudDX® platform. Additionally, the inclusion of 36 Premier Protein® shakes provides a nutritional boost that is not typically part of standard care. This holistic and tech-enabled approach could enhance recovery and surgical outcomes, making it a promising alternative to traditional preoperative preparations.

What evidence suggests that this prehabilitation program is effective for elective surgery?

Research has shown that home-based prehabilitation programs, monitored remotely, can be effective. In this trial, participants in the Prehabilitation Program arm will receive a home-based, virtually monitored multimodal prehabilitation program. This program includes exercises, nutrition, and mindfulness activities to prepare individuals physically for surgery. One study found that remote prehabilitation was practical and improved patients' physical readiness before surgery. Another study demonstrated that these programs can help reduce complications after surgery. This evidence suggests that a home-based prehabilitation program could improve surgical outcomes by better preparing patients before their operations.14567

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+

Citations

a multicentre, pragmatic pilot randomised trial - PMC

A pragmatic, multicentre randomised trial of virtually supported, home-based prehabilitation is required to evaluate effectiveness in generalisable settings ...

Feasibility of a virtual multimodal prehabilitation ...

A technology-assisted prehabilitation program delivered remotely is feasible and could lead to physical benefits for a surgical cancer population.

Prehabilitation Program for Elective Surgery (PRIME Trial)

The study compares a virtually monitored, home-based prehabilitation program—including exercise, nutrition advice, mindfulness training, and ...

Remote Monitoring Model for the Preoperative ...

This article presents a review of the literature and the development of a model that can remotely monitor physical activities during the prehabilitation period.

NCT07590141 | Prehabilitation Before Major Surgery

This study proposes a virtually monitored, home-based multimodal prehabilitation program designed to balance feasibility, adherence, and ...

Prehabilitation Before Major Surgery - ClinicalTrials.Veeva

The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for ...

Multi-Component Prehabilitation Program for High-Risk ...

The purpose of this feasibility pilot study is to understand how a prehabilitation program for older adults with frailty can best be ...