Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair (REHAB-AAA)

Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair-REHAB-AAA, a Randomised Controlled Pilot Study

Evidence about the benefit of cardiovascular rehabilitation (CR) after open or endovascular repair of an infrarenal aortic aneurysm is lacking. The positive effect of CR on the cardiovascular fitness, quality of life and mortality is well established in other cardiovascular fields like cardiac surgery.

The aim of this study is to determine whether participation in a structured CR, compared with standard postoperative care (SC), results in greater improvements in cardiorespiratory fitness in patients following abdominal aortic aneurysm repair.

The study will also evaluate whether CR, compared with SC, improves health-related quality of life, reduces cardiovascular risk-factors and adverse cardiovascular events and preserves of cognitive function over the follow-up period. Furthermore, the number of complications and reoperations will be evaluated.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Other: Structured cardiovascular rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michaela Enzmann, MD; Phone Number: +43 50504 22587; Email: michaela.enzmann@i-med.ac.at
• Study Contact Backup: Name: Angelika Gratl; Phone Number: +43 50504 22587; Email: angelika.gratl@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with an abdominal aortic aneurysm (AAA) and an indication for repair, ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Acute AAA repair
• AAA size ≥7cm
• Para/suprarenal AAA
• AAA due to a connective tissue disorder
• Impaired mobility
• Life expectancy <12 months
• Severe co-morbidities influencing or preventing CR (e.g. ≥COPD II, PAD ≥ Rutherford 3, dialysis)
• Participation in another interventional study that may confound the study endpoints
• Patients <18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiovascular rehabilitation; This group receives a three-week inpatient cardiovascular rehabilitation program three months after the procedure.	Other: Structured cardiovascular rehabilitation; Participants after open or endovascular abdominal aortic aneurysm repair will receive a three-week inpatient structured cardiovascular rehabilitation program three months after the procedure.; Other Names: cardiovascular rehabilitation
No Intervention: Standard care; Participants assigned to standard care will be advised to optimize their cardiovascular risk factors and to engage in regular moderate-intensity cardiovascular exercise; however, no supervised cardiovascular rehabilitation or structured exercise program will be prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of VO2max	Maximal oxygen uptake	Before the procedure and 1 year after aortic repair
6-minute walking distance (6MWD)	Walking distance after 6 minutes	Before the procedure and 1 year after aortic repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the results of the The Short Form (36) Health Survey (SF-36) questionnaire	Quality of life questionnaire evaluating 36 items on a scale of 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability	Before surgery and 1 year after aortic repair
Surgery related complications and reoperations	Number of surgically related complications and reoperations	After 30 days and after 1 year after aortic repair.
Change of blood pressure		Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.
Mini-mental state examination	Change of the mini-mental-score (0-30 points). Any score of 24 or more indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.	Preoperative and 1 year after aortic repair.
Major adverse cardiovascular events (MACE)	Number of composite adverse cardiovascular events: non-fatal myocardial infarction, stroke, coronary and peripheral arterial disease revascularization, non-traumatic amputation	30 days and 1 year after aortic repair.
Serum lipid profile		Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Michaela Enzmann, MD, Department of Vascular Surgery, Medical University of Innsbruck, Austria

Publications and helpful links

General Publications

• 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.
• Wee IJY, Choong AMTL. A systematic review of the impact of preoperative exercise for patients with abdominal aortic aneurysm. J Vasc Surg. 2020 Jun;71(6):2123-2131.e1. doi: 10.1016/j.jvs.2018.09.039. Epub 2019 Jan 1.
• Aronov D, Bubnova M, Iosseliani D, Orekhov A. Clinical Efficacy of small a, Cyrillic Medical Centre- and Home-based Cardiac Rehabilitation Program for Patients with Coronary Heart Disease After Coronary Bypass Graft Surgery. Arch Med Res. 2019 Apr;50(3):122-132. doi: 10.1016/j.arcmed.2019.07.007. Epub 2019 Aug 7.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: abdominal aortic aneurysm; endovascular aortic repair; cardiovascular rehabilitation; open aortic repair
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Cardiac Rehabilitation
• Other Study ID Numbers: EK Nr: 1128/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study relevant pseudonymized IPD will be shared by the study team upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No