Clinical trial NCT05756283: The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair
Official title: The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Prehabilitation
Exercise
Nutrition
Quality of life
Postoperative Complications
Psychosocial intervention
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-03-06
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications measured by the Comprehensive Complication Index (CCI)
timeFrame: CCI will be measured from admission to 6 weeks postoperatively
Secondary outcomes:
measure: ICU Length of stay
timeFrame: From admission to 6 weeks postoperatively
measure: Hospital length of stay
timeFrame: From admission to 6 weeks postoperatively
measure: Reinterventions
timeFrame: from surgery day to 6 week postoperatively
measure: Readmission
timeFrame: at 6 weeks and at 1 year postoperatively
measure: Emergency Room visits
timeFrame: at 6 weeks and at 1 year postoperatively
measure: 6-Minute Walk Test
timeFrame: Measured at baseline, preoperatively and 6 weeks postoperatively
measure: VO2 peak
timeFrame: Measured at baseline and preoperatively
measure: VO2 AT
timeFrame: Measured at baseline and preoperatively
measure: VE/VCO2
timeFrame: Measured at baseline and preoperatively
measure: Yale physical activity survey (YPAS)
timeFrame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
measure: SF36
timeFrame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
measure: Depression
timeFrame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
measure: Anxiety
timeFrame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
measure: Patient Generated Subjective Global Assessment (PG-SGA)
timeFrame: Measured at baseline, preoperatively
measure: Compliance to intervention
timeFrame: Measured from baseline to preoperatively
measure: Fidelity to exercise intervention
timeFrame: Measured from baseline to preoperatively
measure: Height
timeFrame: Measured at baseline and preoperatively
measure: Weight
timeFrame: Measured at baseline and preoperatively
measure: Body Mass Index (BMI)
timeFrame: Measured at baseline and preoperatively
measure: Body Fat percentage
timeFrame: Measured at baseline and preoperatively
measure: Fat Free Mass (FFM)
timeFrame: Measured at baseline and preoperatively
measure: Muscle Mass
timeFrame: Measured at baseline and preoperatively
measure: Phase angle
timeFrame: Measured at baseline and preoperatively
measure: Satisfaction and acceptability
timeFrame: Preoperative assessment
measure: Incidents of adverse events (prehabilitation safety and tolerability)
timeFrame: Measured from Baseline to Preoperatively
measure: Quality adjusted life years
timeFrame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
measure: Prehabilitation cost-effectiveness
timeFrame: Measured at 1 year postoperatively
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: MUHC-RIMUHC Royal Victoria Hospital
state: Quebec
Study officials:
References:
citation: Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
citation: Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):47-53. doi: 10.1097/SLA.0000000000001609.
citation: Tew GA, Batterham AM, Colling K, Gray J, Kerr K, Kothmann E, Nawaz S, Weston M, Yates D, Danjoux G. Randomized feasibility trial of high-intensity interval training before elective abdominal aortic aneurysm repair. Br J Surg. 2017 Dec;104(13):1791-1801. doi: 10.1002/bjs.10669. Epub 2017 Oct 9.
citation: Fenton C, Tan AR, Abaraogu UO, McCaslin JE. Prehabilitation exercise therapy before elective abdominal aortic aneurysm repair. Cochrane Database Syst Rev. 2021 Jul 8;7(7):CD013662. doi: 10.1002/14651858.CD013662.pub2.
citation: Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902.