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: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Surgical prehabilitation is the process of enhancing one's physical function and mental capacity to enable him/or her to withstand the stressor of surgery. Prehabilitation can be achieved via optimizing physical fitness, nutrition, and psychological health. Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery. Despite the growing interest in the field of prehabilitation, little is understood about how to implement prehabilitation an integrated clinical service. This study will examine the effect of a prehabilitation program that includes exercise, psychological, and nutritional optimization that emulates clinical integration pathways. Participants of this study will have a choice of participating in facility-based prehabilitation (FBP) or home-based prehabilitation (HBP) depending on their needs/accessibility to the Toronto General Hospital. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 and 90 days postoperatively. A comprehensive assessment of feasibility will also be conducted to better understand facilitators and barriers to clinical integration.

Research Team

Daniel Santa Mina, PhD

Principal Investigator

University of Toronto

Ian Randall, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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).

Treatment Details

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.

Participant Groups

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+