Prehabilitation Program for Surgical Patients

Overseen By Ian Randall, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a prehabilitation program can help people handle surgery better and recover faster. Participants will engage in exercise, nutritional optimization, and psychoeducation (stress management activities) either at a facility or at home. The goal is to identify the best way to integrate these activities into regular medical care. Individuals scheduled for surgery at the University Health Network, who speak English, and are considered higher-risk for surgery might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to innovative approaches in surgical care.

Will I have to stop taking my current medications?

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 surgical patients?

A previous study found that a program called multimodal prehabilitation, which includes exercise, nutrition, and stress management, was safe and well-tolerated by patients. Research shows that these activities can enhance a patient's physical, nutritional, and mental health before surgery. Another study confirmed that exercise programs before surgery are both practical and safe for patients.

For home-based prehabilitation, a review found that this approach also lowers the risk of complications after surgery. Although the evidence is not as strong, it still suggests positive effects on recovery. Home-based programs have shown improvements in physical and mental health.

Overall, both facility-based and home-based prehabilitation methods are safe and helpful. These programs prepare patients for surgery by increasing their strength and mental readiness, without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it evaluates the impact of prehabilitation programs on surgical patients, which is a relatively new approach compared to traditional post-surgery care. Unlike standard care that begins rehabilitation after surgery, these programs start before the procedure, aiming to strengthen the body and mind ahead of time. The facility-based and home-based prehabilitation arms include a unique combination of supervised or unsupervised exercises, personalized nutritional plans with protein supplementation, and psychoeducation for stress management. This proactive approach could potentially improve surgical outcomes and recovery times, providing patients with a more comprehensive preparation that isn't typically offered in conventional care.

What evidence suggests that this prehabilitation program is effective for surgical patients?

Research has shown that prehabilitation before surgery can reduce complications and shorten hospital stays. In this trial, participants will join different treatment arms. For those in the facility-based prehabilitation (FBP) arm, studies have found that supervised exercise can more effectively aid recovery. Many participants complete these programs successfully, indicating they are both engaging and beneficial.

Participants in the home-based prehabilitation (HBP) arm will also experience promising benefits. Studies report that home-based prehabilitation significantly reduces the risk of complications after surgery. Many patients adhere to home-based programs, demonstrating high commitment. Both facility and home-based approaches in this trial aim to improve fitness, nutrition, and mental well-being, leading to better outcomes after surgery. ^{2 3 5 6 7}

Who Is on the Research Team?

Daniel Santa Mina, PhD

Principal Investigator

University of Toronto

Ian Randall, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for English-speaking patients scheduled for surgery at the University Health Network who have been referred by their surgeon because they're considered high-risk, frail, or deconditioned. The surgeon must believe prehabilitation could help them.

Inclusion Criteria

Fluent in English

I am scheduled for surgery at the University Health Network.

Referred by their surgeon with indication for prehabilitation as per the surgeon's clinical impression (i.e. higher-than-average risk candidate; marginal candidate for surgery due to limited physiologic reserve; frail; deconditioned; or other reason with explanation).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a prehabilitation program including exercise, nutrition, and stress management to prepare for surgery

Baseline to surgery

3 supervised exercise sessions per week (facility-based) or 3 unsupervised sessions (home-based)

Surgery

Participants undergo their scheduled surgical procedure

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

90 days

Assessments at 30 and 90 days postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Exercise, Nutritional Optimization, and Psychoeducation

Trial Overview The study tests a prehabilitation program that includes exercise, nutrition guidance, and psychological support to improve recovery from surgery. Participants can choose between facility-based or home-based programs and will be evaluated before and after surgery.

How Is the Trial Designed?

Group I: Home-based prehabilitation (HBP) Experimental Treatment 1 Intervention

Exercise * Three unsupervised, home-based exercise training sessions of aerobic and resistance exercises. Includes continuous moderate-intensity aerobic training and whole-body resistance exercises (60 min/session) * Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery * Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist Nutrition * Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a Registered Dietitian (60 min/session) * Participants will also receive 20g of protein supplementation daily Stress management and behavioural support * Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a psychologist (60 min/session)

Group II: Facility-based prehabilitation (FBP) Experimental Treatment 1 Intervention

Exercise * Three supervised exercise training sessions of aerobic and resistance exercises. Includes high-intensity interval aerobic training and whole-body resistance exercises (60 min/session) * Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery * Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist Nutrition * Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a Registered Dietitian (60 min/session) * Participants will also receive 20g of protein supplementation daily Stress management and behavioural support * Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a psychologist (60 min/session)

Group III: Usual Care Active Control 1 Intervention

\- This group will receive no additional intervention from the routine care.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

MSH-UHN AMO Innovation Fund

Collaborator

Trials

3

Recruited

240+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144543/

Prehabilitation: Impact on Postoperative Outcomes - PMC A recent systematic review reported that the efficacy of exercise prehabilitation was greater in programs with more than 1 supervised exercise ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04155346

Study Details | NCT04155346 | Prehab for Surgery Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324007601

Review Article Real-life effectiveness of prehabilitation to ... Observational studies in a real-life setting showed that prehabilitation can reduce postoperative complications and LoS.

4. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03626-3

The role of exercise-based prehabilitation in enhancing ... The acceptance and completion rates of prehabilitation were commendably high at 61% (95% CI: 47–75%) and 90% (95% CI: 87–93%), respectively, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11947603/

a systematic review and meta-analysis of randomised trials Conclusions. Home-based prehabilitation reduced the proportion of patients with postoperative complications, but with low certainty of evidence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059351/

Prehabilitation, making patients fit for surgery – a new ... Multimodal prehabilitation before surgery increases the patients' physical, nutritional, and mental status before surgery.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ... Details the outcomes of various prehabilitation studies, including their population characteristics, intervention types, and outcome measurements. Key ...