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Prehabilitation for Abdominal Aortic Aneurysm Repair

N/A

Waitlist Available

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm

Be older than 18 years old

Must not have

Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair

Participants with ruptured or symptomatic AAA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 weeks and at 1 year postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether a pre-op program of exercise, nutrition, and psych support can help people with an artery enlargement in the abdomen to reduce complications after surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves non-invasive methods like exercise and nutrition rather than medication or surgery itself, side effects are minimal but may include typical risks associated with starting new exercise routines such as muscle strains.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My abdominal aortic aneurysm is ruptured or causing symptoms.

Select...

My abdominal aorta is 7cm or wider.

Select...

I cannot exercise due to severe joint, muscle, or nerve problems.

Select...

I cannot exercise due to high blood pressure or heart issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks and at 1 year postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks and at 1 year postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks and at 1 year postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative complications measured by the Comprehensive Complication Index (CCI)

Secondary study objectives

6-Minute Walk Test

Anxiety

Body Fat percentage

+24 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met