Prehabilitation for Abdominal Aortic Aneurysm Repair

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

The PREHAAAB trial is for individuals over 50 awaiting elective surgery for an abdominal aortic aneurysm that's less than 7cm wide. Candidates must be able to consent and communicate in English, French, Spanish, or Catalan. It excludes those with ruptured/symptomatic aneurysms, cognitive issues preventing understanding of the study, severe physical limitations to exercise, certain heart conditions or blood pressure concerns.

Inclusion Criteria

I am over 50 and waiting for open surgery on my abdominal aorta, which is less than 6.9cm wide.

Participants should have the ability to give informed consent

Exclusion Criteria

I am having surgery for an aortic aneurysm in my chest or abdomen.

My abdominal aortic aneurysm is ruptured or causing symptoms.

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

+3 more

Participant Groups

This trial tests a pre-surgery program including exercise training, nutritional advice and supplements, plus psychosocial support for patients with abdominal aortic aneurysms. The goal is to reduce post-surgery complications and speed up recovery while also providing long-term health benefits.

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal PrehabilitationExperimental Treatment1 Intervention

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.

Group II: Control group (standard of care)Active Control1 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.