An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.
Abdominal aortic aneurysms (AAA) are asymptomatic until they rupture, which carries an 80- 90% mortality. Therefore, AAA are surgically repaired when they reach 5.0 cm in women and 5.5cm in men. Despite advances to surgical technique and peri-operative care, open surgical repair still carries a high incidence of post-operative complications of 30-40%, and a long recovery period. This is largely because the surgery itself is major abdominal surgery, and these patients often have significant comorbidities and low functional status. Multimodal prehabilitation (MP) is a concept that uses the preoperative timeframe (between diagnosis and surgery) to optimize physical, nutritional, and emotional wellbeing to improve a patient's functional status and ability to withstand the stress of surgery. To date, there is no study evaluating the effect of MP on post-operative complications following open AAA repair. The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA repair compared to standard of care. This trial will also assess the effect of MP on functional capacity, hospital length of stay, 30-day mortality and health related quality of life, as well as to assess cost effectiveness, adherence, and fidelity to the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
EXERCISE * Supervised exercise * High intensity interval training * Strength exercise * Home-based exercise / promotion of physical activity * Low-moderate intensity aerobic training * Inspiratory muscle training * Low-moderate intensity strength training NUTRITION: nutrition education and optimization. Intake of 0.4g/kg of whey isolate after every supervised training. PSYCHOSOCIAL: mindfulness, cognitive reframing and coping strategies.
MUHC-RIMUHC Royal Victoria Hospital
Montreal, Quebec, Canada
Postoperative complications measured by the Comprehensive Complication Index (CCI)
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
Time frame: CCI will be measured from admission to 6 weeks postoperatively
ICU Length of stay
Intensive Care Unit length of stay
Time frame: From admission to 6 weeks postoperatively
Hospital length of stay
Days from admission to discharge from the hospital
Time frame: From admission to 6 weeks postoperatively
Reinterventions
Need for surgical reintervention due to surgical complications
Time frame: from surgery day to 6 week postoperatively
Readmission
Readmission to the hospital
Time frame: at 6 weeks and at 1 year postoperatively
Emergency Room visits
Visits to the emergency room with or without admission to the hospital
Time frame: at 6 weeks and at 1 year postoperatively
6-Minute Walk Test
6-minute walk test
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
VO2 peak
Oxygen consumption at peak exercise
Time frame: Measured at baseline and preoperatively
VO2 AT
Oxygen consumption at anaerobic Threshold
Time frame: Measured at baseline and preoperatively
VE/VCO2
Minute ventilation/carbon dioxide production
Time frame: Measured at baseline and preoperatively
Yale physical activity survey (YPAS)
Questionnaire of daily physical activity
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
SF36
Quality of life questionnaire
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Depression
Depression measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no depression)- 21 (maximal depression)
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Anxiety
Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety)
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Patient Generated Subjective Global Assessment (PG-SGA)
Malnutrition assessment tool
Time frame: Measured at baseline, preoperatively
Compliance to intervention
Compliance to the different components of the intervention, measured by attendance to supervised sessions (%), adherence to nutritional counseling and supplementation (%), adherence to home-based exercise (%) and adherence to the psychosocial sessions (%)
Time frame: Measured from baseline to preoperatively
Fidelity to exercise intervention
Real training wattage and kg vs expected
Time frame: Measured from baseline to preoperatively
Height
measurement of height in meters
Time frame: Measured at baseline and preoperatively
Weight
measurement of Weight in kg
Time frame: Measured at baseline and preoperatively
Body Mass Index (BMI)
Measurement of body mass index (weight and height will be combined to report BMI in kg/m\^2)
Time frame: Measured at baseline and preoperatively
Body Fat percentage
Measurement of body fat percentage using Bioelectrical Impedance Analysis
Time frame: Measured at baseline and preoperatively
Fat Free Mass (FFM)
Measurement of body fa free mass in kg, using Bioelectrical Impedance Analysis
Time frame: Measured at baseline and preoperatively
Muscle Mass
Measurement of muscle mass in kg, using Bioelectrical Impedance Analysis
Time frame: Measured at baseline and preoperatively
Phase angle
Measurement of phase angle, using Bioelectrical Impedance Analysis
Time frame: Measured at baseline and preoperatively
Satisfaction and acceptability
Intervention satisfaction and acceptability questionnaire
Time frame: Preoperative assessment
Incidents of adverse events (prehabilitation safety and tolerability)
Incidence of adverse events and severe adverse events during prehabilitation program
Time frame: Measured from Baseline to Preoperatively
Quality adjusted life years
Quality adjusted life years derived from SF36 data (SF6D)
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Prehabilitation cost-effectiveness
Measurement of prehabilitation cost-effectiveness using data from SF6D, prehabilitation costs and hospitalization related costs.
Time frame: Measured at 1 year postoperatively
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