Prehab for Surgery

Preoperative Care Clinical Trial

Official title:

Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04155346
• Other study ID #: 19-5573
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Preoperative Care
• Surgical Patients

Intervention

Behavioral:
• Exercise, nutritional optimization, and psychoeducation
Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	MSH-UHN AMO Innovation Fund, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Hospital length of stay	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.	Up to 90-days postoperatively
Secondary	Postoperative complications and mortality	Complications, including mortality, will follow the Clavien-Dindo classification. Any health event that requires readmission will also be documented.	Up to 90-days postoperatively
Secondary	Changes in aerobic functional capacity	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.	Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary	Changes in musculoskeletal functional capacity	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.	Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary	Changes in body composition	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.	Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary	Changes in HRQOL	HRQOL will be measured by Short Form-12 Health Survey (SF-12) and the EuroQol-5 Dimension (EQ5D). Measured only in participants of prehabilitation.	Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary	Changes in depression	Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Measured only in participants of prehabilitation.	Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary	Changes in diet	Changes in diet and healthy eating practices will be measured by the 3-day diet record. Measured only in participants of prehabilitation.	Baseline and 1 week prior to surgery