Clinical trial NCT04155346: Prehab for Surgery
Official title: Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Patients
Preoperative Care
Keywords: Exercise
Nutrition
Psychology
Prehabilitation
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: MSH-UHN AMO Innovation Fund
First posted: 2019-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effectiveness-Implementation hybrid model
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Referral and Enrollment Data
timeFrame: Baseline
measure: Window of opportunity
timeFrame: Baseline to surgery
measure: Intervention adherence and fidelity
timeFrame: Baseline to surgery
measure: Study retention
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Barriers and facilitators
timeFrame: 30-day postoperatively
measure: Safety and adverse events
timeFrame: Baseline to surgery
measure: Economic feasibility (hospital perspective)
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Economic feasibility (patient perspective)
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 90-days postoperatively
measure: Postoperative complications and mortality
timeFrame: Up to 90-days postoperatively
measure: Changes in aerobic functional capacity
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Changes in musculoskeletal functional capacity
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Changes in body composition
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Changes in HRQOL
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Changes in depression
timeFrame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
measure: Changes in diet
timeFrame: Baseline and 1 week prior to surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto
name: Daniel Santa Mina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Ian Randall, MD
role: PRINCIPAL_INVESTIGATOR
References: