Prehab for Surgery

NCT04155346 | Active Not Recruiting

• 1 other identifier: 19-5573
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Patients; Preoperative Care

Keywords

Exercise; Nutrition; Psychology; Prehabilitation

Outcome Measures

Primary Outcomes (8)

• Referral and Enrollment Data

  * The number of eligible patients per month who consent for surgery will be ascertained via the preadmission clinic databases. * The total number of referrals received from surgeons. * The number of patients that agree to participate in the prehabilitation program. * Demographics, disease characteristics, and treatment type will be captured for prehabilitation participants * Referred patients who decline participation in the study will be compared to all consenting participants using information provided on the referral form * For those who fail screening or decline participation, we will log their demographic and reasons for non-participation.

  Baseline

• Window of opportunity

  The 'prehabilitation window' will be recorded and is operationally defined as the time from program referral to the date of surgery. We will also describe the total preoperative period (time between consent for surgery and date of surgery) and prehabilitation program duration (time from program initiation to surgery). Each of these periods will be recorded in days.

  Baseline to surgery

• Intervention adherence and fidelity

  * Adherence for FBP participants will be recorded via attendance to each in-person session. Fidelity and adherence will be further measured by detailed recording of performance on the aerobic and resistance training components of the exercise sessions. * HBP participants will be contacted weekly via telephone or email for adherence recording by the research coordinator. A logbook will be used to self-report HBP participants' home-based exercise that contains specific fields to capture all session details. * Adherence to stress management and utilization of smoking cessation tools (as required) will be recorded weekly using a logbook within the participant manuals. This includes the number of relaxation sessions per week; compliance with dietary recommendations for dietary behaviours, protein supplementation, and for smokers, the tools used, and the number of times accessed.

  Baseline to surgery

• Study retention

  \- The frequency of drop-out during program participation will be documented including reasons for drop-out. Descriptive statistics for demographic data and reasons will be used to describe program completers and drop-outs.

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

• Barriers and facilitators

  Qualitative content analysis on barriers and facilitators for prehabilitation participation and engagement will be conducted using semi-structured interviews. Both participants of prehabilitation and usual care will be asked to participate in interviews via telephone or in-person. To reach saturation for identifying meta-themes within a heterogenous population, sample of has been suggested 15 for the collection of prevalent and more salient ideas.

  30-day postoperatively

• Safety and adverse events

  Any safety or adverse events related to the prehabilitation intervention will be reported at each in-person session for FBP participants and during weekly telephone calls with HBP participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.

  Baseline to surgery

• Economic feasibility (hospital perspective)

  A cost impact on the perspective of the hospital will be conducted based on primary hospital length of stay, readmission, and readmission length of stay. This will be used to determine cost differences between those that participate in prehabilitation (FBP and HBP) compared to usual care.

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

• Economic feasibility (patient perspective)

  Patient-perspective costing will be measured by a patient-reported cost-diary. This includes: direct healthcare cost (i.e. visits to the general practice, specialists care, unities applied to prescribed medication); direct non-health care costs (i.e. cost of over-the-counter medication, cost of health activities, hours of paid and unpaid household help, transportation, and value of other out-of-pocket expenses, with specifics on exercise-related expenses)l and indirect costs (i.e. number of days absent from work, days lost from housekeeping, and other daily activities).

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

Secondary Outcomes (8)

• Hospital length of stay

  Up to 90-days postoperatively

• Postoperative complications and mortality

  Up to 90-days postoperatively

• Changes in aerobic functional capacity

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

• Changes in musculoskeletal functional capacity

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

• Changes in body composition

  Baseline, 1 week prior to surgery, 30- and 90-day postoperatively

Study Arms (3)

Facility-based prehabilitation (FBP)

EXPERIMENTAL

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)

Behavioral: Exercise, nutritional optimization, and psychoeducation

Home-based prehabilitation (HBP)

EXPERIMENTAL

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)

Behavioral: Exercise, nutritional optimization, and psychoeducation

Usual Care

NO INTERVENTION

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

Interventions

Exercise, nutritional optimization, and psychoeducation BEHAVIORAL

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

Facility-based prehabilitation (FBP); Home-based prehabilitation (HBP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator
• MSH-UHN AMO Innovation Fund: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Daniel Santa Mina, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Ian Randall, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Effectiveness-Implementation hybrid model

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 7, 2019
• Study Start: November 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: December 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CA (1)