Prehab for Surgery

NCT ID: NCT04155346

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

There is growing interest in the role of prehabilitation to reduce surgical risk, attenuate surgery-related deconditioning, and facilitate postoperative recovery. Compared to the postoperative setting, initiating health interventions preoperatively is proposed as an important strategy to improve health outcomes because: i) it targets modifiable risk factors for surgical complications; ii) patients may be more physically and/or psychologically capable of affecting change in health status compared to the early postoperative period; iii) wait times prior to surgery may be several weeks thus representing an opportunity to proactively invest in their recovery; and iv) patients may be sensitized to the importance of adverse health behaviours that may have contributed to the need for surgery (i.e. a 'teachable moment'). The potential benefit of prehabilitation extends beyond potential gains in health from baseline to surgery, but also includes the prevention or attenuation of deconditioning that patients experience during the postoperative period. The findings of recent systematic reviews and meta-analyses assessing the benefits of prehabilitation interventions in surgical patients provide support for their efficacy in improving physical fitness, length of stay, surgical complication rates, and health-related quality of life (HRQOL).

While previous interventional studies have demonstrated promising findings, little is known about how feasible it is to integrate prehabilitation into standard of care for people awaiting surgery. This study intends to employ intervention design features previously shown to be feasible and efficacious and employs a hybrid effectiveness-implementation trial design model to assess feasibility of clinical integration.

Conditions

Surgical Patients; Preoperative Care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Facility-based prehabilitation (FBP)

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 Type: EXPERIMENTAL

Exercise, nutritional optimization, and psychoeducation

Intervention Type: BEHAVIORAL

Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model

Home-based prehabilitation (HBP)

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 Type: EXPERIMENTAL

Exercise, nutritional optimization, and psychoeducation

Intervention Type: BEHAVIORAL

Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise, nutritional optimization, and psychoeducation

Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Planned for surgery at the University Health Network
• Fluent in English
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

MSH-UHN AMO Innovation Fund

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Daniel Santa Mina, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Santa Mina, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Ian Randall, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

19-5573

Identifier Type: -

Identifier Source: org_study_id