Prehabilitation for Abdominal Aortic Aneurysm Repair

Not yet recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pre-surgery program for individuals with abdominal aortic aneurysms, a condition where a major artery in the abdomen enlarges dangerously. The program, called Multimodal Prehabilitation, includes exercise, nutrition advice, and emotional support to aid faster recovery with fewer complications post-surgery. It targets individuals awaiting elective aneurysm repair surgery who can actively engage in exercise and lifestyle changes. Participants will either receive standard care or participate in the new program to determine if it leads to better health outcomes and cost savings. As an unphased trial, this study allows patients to contribute to innovative care strategies that may enhance recovery and improve quality of life.

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 prior data suggests that this prehabilitation program is safe for patients undergoing abdominal aortic aneurysm repair?

Research has shown that preparing for surgery with exercise, good nutrition, and mental health support is generally safe. One study found this approach safe and feasible for individuals awaiting aneurysm repair surgery. Another review confirmed that most patients could complete these programs without major issues.

These findings suggest that this preparation method is well-tolerated, offering a promising way to enhance health before surgery. This could lead to fewer post-surgery complications and a quicker recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about multimodal prehabilitation for abdominal aortic aneurysm repair because it goes beyond the standard care of comorbidity optimization, anemia correction, and smoking cessation advice. This approach is unique in that it includes a personalized 6-week program designed to boost patients' health before surgery. By focusing on patient engagement and empowerment, it aims to improve surgical outcomes and recovery, offering a proactive way to prepare patients for the challenges of major surgery.

What evidence suggests that this multimodal prehabilitation is effective for reducing complications after abdominal aortic aneurysm surgery?

Research shows that preparing for surgery with exercise, good nutrition, and mental health support can reduce complications after major surgeries. Previous studies have found that this approach significantly decreases post-surgery issues and improves the quality of life for patients, especially those receiving cancer treatment. In this trial, participants in the intervention group will follow a personalized multimodal prehabilitation program, which includes these pre-surgery efforts, to optimize their preoperative health status. For surgeries like abdominal aortic aneurysm repair, evidence suggests that exercise can boost physical fitness and lower the risk of complications. These pre-surgery efforts help patients recover faster and more effectively. In short, taking active steps before surgery can significantly improve recovery outcomes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Participants should have the ability to give informed consent

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05756283

Study Details | NCT05756283 | The PREHAAAB Trial: ... The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA ...

2. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(24)00374-1/fulltext

Feasibility and Efficacy of a Multimodal Prehabilitation ... Multimodal prehabilitation (MP) has shown a significant decrease in postoperative complications accompanied by an improvement of the quality of life in oncology ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38158811/

Multimodal Prehabilitation for Patients Undergoing ... Multimodal prehabilitation is safe and feasible in patients awaiting endovascular aneurysm repair. The importance of this finding is that ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1078588421000940

The Content of Pre-habilitative Interventions for Patients ... This study provides a review of current evidence investigating pre-habilitation in patients undergoing abdominal aorta aneurysm (AAA) repair and its effects on ...

5. withpower.com withpower.com/trial/phase-aneurysm-8-2023-0cacd

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8275457/

Prehabilitation exercise therapy before elective abdominal ... We included randomised controlled trials (RCTs) that compared exercise therapy with usual care (no exercise) before elective abdominal aortic aneurysm (AAA) ...