Prehabilitation for Abdominal Aortic Aneurysm Repair

Overseen By Marie-Amelie Lucaszewski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Thoracic repair, Ruptured AAA, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

152 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Multimodal Prehabilitation for Abdominal Aortic Aneurysm Repair?

Research shows that preoperative exercise, a component of multimodal prehabilitation, can improve physical fitness and reduce complications after abdominal aortic aneurysm surgery. Supervised exercise programs have been found to enhance cardiorespiratory fitness and improve both short-term and long-term outcomes for these patients. ^{1 2 3 4 5}

Is prehabilitation safe for patients undergoing abdominal aortic aneurysm repair?

Prehabilitation, which includes exercise and other interventions before surgery, is generally considered safe and has shown promise in reducing complications after major surgeries. However, specific high-quality research on its safety for abdominal aortic aneurysm repair is limited, but it is based on successful outcomes in other surgical groups. ^{2 5 6 7 8}

How does the treatment Multimodal Prehabilitation differ from other treatments for abdominal aortic aneurysm repair?

Multimodal Prehabilitation is unique because it combines exercise, nutrition, and psychological interventions before surgery to improve recovery, unlike traditional treatments that focus solely on the surgical procedure itself. This approach aims to enhance overall fitness and resilience, potentially leading to better outcomes and fewer complications after surgery. ^{9 10 11 12 13}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a personalized multimodal prehabilitation program including exercise training, nutritional advice, and psychosocial support to optimize preoperative health status.

6 weeks

Regular sessions (frequency not specified)

Surgery and Immediate Postoperative Care

Participants undergo open abdominal aortic aneurysm repair surgery and receive immediate postoperative care.

Hospital stay up to 6 weeks postoperatively

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of complications, functional capacity, and quality of life.

1 year

Assessments at 6 weeks and 1 year postoperatively

Treatment Details

Interventions

• Multimodal Prehabilitation

Trial Overview 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.

Participant Groups

Group I: Multimodal Prehabilitation Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A 4-week prehabilitation program involving physical therapy, nutritional support, and psychological preparation was safely implemented in 60 out of 106 patients scheduled for major abdominal surgery, with no cardiovascular events reported during the program.

Patients showed significant improvements in physical function (6-minute walking distance increased by 9.3%) and psychological well-being, suggesting that prehabilitation can enhance recovery and quality of life before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation before major abdominal surgery: Evaluation of the impact of a perioperative clinical pathway, a pilot study. Boukili, IE., Flaris, AN., Mercier, F., et al.[2022]

A 4-week intensive rehabilitation program using either interval training with active recovery (ITAR) or conventional training (CT) for patients with intermittent claudication showed high adherence and excellent tolerance, with no adverse events reported.

Both training methods significantly improved maximum walking distance on a graded treadmill, achieving similar results, which suggests that shorter, intensive training programs can be as effective as longer conventional ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. Villemur, B., Thoreau, V., Guinot, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Pre-operative Exercise Therapy in Patients with an Abdominal Aortic Aneurysm: A Systematic Review. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the impact of preoperative exercise for patients with abdominal aortic aneurysm. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A preoperative supervised exercise program potentially improves long-term survival after elective abdominal aortic aneurysm repair. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Content of Pre-habilitative Interventions for Patients Undergoing Repair of Abdominal Aortic Aneurysms and Their Effect on Post-Operative Outcomes: A Systematic Review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Prehabilitation for Vascular Surgery Patients: Challenges and Opportunities. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Prehabilitation exercise therapy before elective abdominal aortic aneurysm repair. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Prehabilitation before major abdominal surgery: Evaluation of the impact of a perioperative clinical pathway, a pilot study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease: A Case Report. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Presurgery exercise-based conditioning interventions (prehabilitation) in adults undergoing lower limb surgery for peripheral arterial disease. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Multimodal Prehabilitation to Improve Quality of Life and Functional Capacity in Peripheral Arterial Disease: A Case Series. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Moderate Exercise Allows for shorter Recovery Time in Critical Limb Ischemia. [2020]