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

Overview

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

• Behavioral Multimodal 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.

Primary outcome measures

• Postoperative complications measured by the Comprehensive Complication Index (CCI) [Time frame: CCI will be measured from admission to 6 weeks postoperatively]

Secondary outcome measures (12)

• ICU Length of stay [Time frame: From admission to 6 weeks postoperatively]
• Hospital length of stay [Time frame: From admission to 6 weeks postoperatively]
• Reinterventions [Time frame: from surgery day to 6 week postoperatively]
• Readmission [Time frame: at 6 weeks and at 1 year postoperatively]
• Emergency Room visits [Time frame: at 6 weeks and at 1 year postoperatively]
• 6-Minute Walk Test [Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively]
• VO2 peak [Time frame: Measured at baseline and preoperatively]
• VO2 AT [Time frame: Measured at baseline and preoperatively]
• VE/VCO2 [Time frame: Measured at baseline and preoperatively]
• Yale physical activity survey (YPAS) [Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively]
• SF36 [Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively]
• Depression [Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• MUHC-RIMUHC Royal Victoria Hospital — Montreal

Publications

• 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. PMID 28489682
• 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. PMID 26756766
• 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. PMID 28990651
• 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. PMID 34236703
• 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. PMID 30272585
• Coca-Martinez M, Doonan RJ, Gillis C, Mackenzie K, Obrand DI, Bayne JP, Steinmetz OK, Girsowicz E, Lopez-Baamonde M, Jessula S, Yugueros X, Martinez-Palli G, Gill HL. The PREHAAAB Trial: Multimodal prehabilitation for patients awaiting open abdominal aortic aneurysm repair - A study protocol for an international randomized controlled trial. PLoS One. 2025 Dec 29;20(12):e0339473. doi: 10.1371/journ PMID 41460856

Identifiers

NCT: NCT05756283 · PREHAAAB Trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗