Prehab for Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04155346 |
Recruitment Status :
Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : June 8, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Surgical Patients Preoperative Care | Behavioral: Exercise, nutritional optimization, and psychoeducation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Effectiveness-Implementation hybrid model |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients |
Actual Study Start Date : | November 1, 2019 |
Actual Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | June 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Facility-based prehabilitation (FBP)
Exercise
Nutrition
Stress management and behavioural support
|
Behavioral: Exercise, nutritional optimization, and psychoeducation
Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model |
Experimental: Home-based prehabilitation (HBP)
Exercise
Nutrition
Stress management and behavioural support
|
Behavioral: Exercise, nutritional optimization, and psychoeducation
Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model |
No Intervention: Usual Care
- This group will receive no additional intervention from the routine care.
|
- Referral and Enrollment Data [ Time Frame: Baseline ]
- 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.
- Window of opportunity [ Time Frame: Baseline to surgery ]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.
- Intervention adherence and fidelity [ Time Frame: Baseline to surgery ]
- 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.
- Study retention [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]- 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.
- Barriers and facilitators [ Time Frame: 30-day postoperatively ]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.
- Safety and adverse events [ Time Frame: Baseline to surgery ]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.
- Economic feasibility (hospital perspective) [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]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.
- Economic feasibility (patient perspective) [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]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).
- Hospital length of stay [ Time Frame: Up to 90-days postoperatively ]Postoperative length of stay will be recorded from the patient's medical record. This will be calculated from the date of surgery until to the date of discharge from the hospital and recorded in hours.
- Postoperative complications and mortality [ Time Frame: Up to 90-days postoperatively ]Complications, including mortality, will follow the Clavien-Dindo classification. Any health event that requires readmission will also be documented.
- Changes in aerobic functional capacity [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]Aerobic functional capacity will be measured using the Six-Minute Walk Test (6MWT). Total distance travelled for 6 minutes will be recorded. Measured only in participants of prehabilitation.
- Changes in musculoskeletal functional capacity [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]Musculoskeletal functional capacity will be assessed via grip strength. Peak isometric force generated for both arms will be recorded in kg-force. Measured only in participants of prehabilitation.
- Changes in body composition [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]Body composition will be measured via bioelectric impedance analysis using mBCA 514 (Seca, Hamburg, Germany). Body fat percentage, fat and fat free mass, impedance, resistance, and phase angle will be recorded. Measured only in participants of prehabilitation.
- Changes in HRQOL [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]HRQOL will be measured by Short Form-12 Health Survey (SF-12) and the EuroQol-5 Dimension (EQ5D). Measured only in participants of prehabilitation.
- Changes in depression [ Time Frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively ]Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Measured only in participants of prehabilitation.
- Changes in diet [ Time Frame: Baseline and 1 week prior to surgery ]Changes in diet and healthy eating practices will be measured by the 3-day diet record. Measured only in participants of prehabilitation.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155346
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Daniel Santa Mina, PhD | University of Toronto | |
Principal Investigator: | Ian Randall, MD | University Health Network, Toronto |
Responsible Party: | Daniel Santa Mina, PhD, Assistant Professor, University of Toronto |
ClinicalTrials.gov Identifier: | NCT04155346 |
Other Study ID Numbers: |
19-5573 |
First Posted: | November 7, 2019 Key Record Dates |
Last Update Posted: | June 8, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Exercise Nutrition Psychology Prehabilitation |