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The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair

The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05756283
Enrollment
152
Registered
2023-03-06
Start date
2023-09-30
Completion date
2027-09-30
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

Prehabilitation, Exercise, Nutrition, Quality of life, Postoperative Complications, Psychosocial intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMultimodal Prehabilitation

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm. Participants should have the ability to give informed consent.

Exclusion criteria

* Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair. * Participants with ruptured or symptomatic AAA. * Participants with AAA maximal diameter ≥7cm. * Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise. * Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability. * Cognitive impairment that would impede understanding of study procedures, informed consent or study questionnaires or the inability to effectively communicate in English/French/Spanish/Catalan.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complications measured by the Comprehensive Complication Index (CCI)CCI will be measured from admission to 6 weeks postoperativelyThe 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

Secondary

MeasureTime frameDescription
Yale physical activity survey (YPAS)Measured at baseline, preoperatively, 6 weeks and 1 year postoperativelyQuestionnaire of daily physical activity
ICU Length of stayFrom admission to 6 weeks postoperativelyIntensive Care Unit length of stay
Hospital length of stayFrom admission to 6 weeks postoperativelyDays from admission to discharge from the hospital
Reinterventionsfrom surgery day to 6 week postoperativelyNeed for surgical reintervention due to surgical complications
Readmissionat 6 weeks and at 1 year postoperativelyReadmission to the hospital
Emergency Room visitsat 6 weeks and at 1 year postoperativelyVisits to the emergency room with or without admission to the hospital
6-Minute Walk TestMeasured at baseline, preoperatively and 6 weeks postoperatively6-minute walk test
VO2 peakMeasured at baseline and preoperativelyOxygen consumption at peak exercise
VO2 ATMeasured at baseline and preoperativelyOxygen consumption at anaerobic Threshold
VE/VCO2Measured at baseline and preoperativelyMinute ventilation/carbon dioxide production
DepressionMeasured at baseline, preoperatively, 6 weeks and 1 year postoperativelyDepression measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no depression)- 21 (maximal depression)
AnxietyMeasured at baseline, preoperatively, 6 weeks and 1 year postoperativelyAnxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety)
Patient Generated Subjective Global Assessment (PG-SGA)Measured at baseline, preoperativelyMalnutrition assessment tool
SF36Measured at baseline, preoperatively, 6 weeks and 1 year postoperativelyQuality of life questionnaire
Fidelity to exercise interventionMeasured from baseline to preoperativelyReal training wattage and kg vs expected
HeightMeasured at baseline and preoperativelymeasurement of height in meters
WeightMeasured at baseline and preoperativelymeasurement of Weight in kg
Body Mass Index (BMI)Measured at baseline and preoperativelyMeasurement of body mass index (weight and height will be combined to report BMI in kg/m\^2)
Body Fat percentageMeasured at baseline and preoperativelyMeasurement of body fat percentage using Bioelectrical Impedance Analysis
Fat Free Mass (FFM)Measured at baseline and preoperativelyMeasurement of body fa free mass in kg, using Bioelectrical Impedance Analysis
Muscle MassMeasured at baseline and preoperativelyMeasurement of muscle mass in kg, using Bioelectrical Impedance Analysis
Phase angleMeasured at baseline and preoperativelyMeasurement of phase angle, using Bioelectrical Impedance Analysis
Satisfaction and acceptabilityPreoperative assessmentIntervention satisfaction and acceptability questionnaire
Incidents of adverse events (prehabilitation safety and tolerability)Measured from Baseline to PreoperativelyIncidence of adverse events and severe adverse events during prehabilitation program
Quality adjusted life yearsMeasured at baseline, preoperatively, 6 weeks and 1 year postoperativelyQuality adjusted life years derived from SF36 data (SF6D)
Prehabilitation cost-effectivenessMeasured at 1 year postoperativelyMeasurement of prehabilitation cost-effectiveness using data from SF6D, prehabilitation costs and hospitalization related costs.
Compliance to interventionMeasured from baseline to preoperativelyCompliance 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 (%)

Countries

Canada

Contacts

Primary ContactHeather Gill, MD
heather.gill@mail.mcgill.ca+1 514.934.1934
Backup ContactMarie-Amelie Lucaszewski, PhD
+1 514.934.1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026