- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155346
Prehab for Surgery
Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Facility-based prehabilitation (FBP)
Exercise
Nutrition
Stress management and behavioural support
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referral and Enrollment Data
Time Frame: Baseline
|
|
Baseline
|
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.
|
Baseline to surgery
|
Intervention adherence and fidelity
Time Frame: Baseline to surgery
|
|
Baseline to surgery
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
30-day postoperatively
|
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.
|
Baseline to surgery
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
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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).
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 90-days postoperatively
|
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.
|
Up to 90-days postoperatively
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
|
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.
|
Baseline and 1 week prior to surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Santa Mina, PhD, University of Toronto
- Principal Investigator: Ian Randall, MD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-5573
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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