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

NCT05756283 | Not Yet Recruiting DMC

• 1 other identifier: PREHAAAB Trial
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  CCI will be measured from admission to 6 weeks postoperatively

Secondary Outcomes (27)

• ICU Length of stay

  From admission to 6 weeks postoperatively

• Hospital length of stay

  From admission to 6 weeks postoperatively

• Reinterventions

  from surgery day to 6 week postoperatively

• Readmission

  at 6 weeks and at 1 year postoperatively

• Emergency Room visits

  at 6 weeks and at 1 year postoperatively

Study Arms (2)

Multimodal Prehabilitation

EXPERIMENTAL

Participants in the intervention group will undergo, in addition to the standard of care, 6+/-1 weeks of a personalized multimodal prehabilitation program. The interventions included will be patient-centered, aiming to optimize patients' preoperative health status while enhancing their empowerment and engagement.

Behavioral: Multimodal Prehabilitation

Control group (standard of care)

NO INTERVENTION

Participants in the control group will receive the standard of care. This will include comorbidity optimization, anemia correction and smoking cessation advice if deemed appropriate.

Interventions

Multimodal Prehabilitation BEHAVIORAL

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.

Multimodal Prehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

MUHC-RIMUHC Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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/journal.pone.0339473. eCollection 2025.

  PMID: 41460856 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Motor Activity; Postoperative Complications

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Heather Gill, MD

CONTACT

+1 514.934.1934; heather.gill@mail.mcgill.ca

Marie-Amelie Lucaszewski, PhD

CONTACT

+1 514.934.1934

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 6, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)