Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair

NCT07690046 | Not Yet Recruiting

• 1 other identifier: EK Nr: 1128/2026
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

cardiovascular rehabilitation; abdominal aortic aneurysm; endovascular aortic repair; open aortic repair

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change of the results of the The Short Form (36) Health Survey (SF-36) questionnaire

  Before surgery and 1 year after aortic repair

• Surgery 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

  Preoperative and 1 year after aortic repair.

• Major adverse cardiovascular events (MACE)

  30 days and 1 year after aortic repair.

Study Arms (2)

Cardiovascular rehabilitation

EXPERIMENTAL

This group receives a three-week inpatient cardiovascular rehabilitation program three months after the procedure.

Other: Structured cardiovascular rehabilitation

Standard care

NO INTERVENTION

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.

Interventions

Structured cardiovascular rehabilitation OTHER

Participants after open or endovascular abdominal aortic aneurysm repair will receive a three-week inpatient structured cardiovascular rehabilitation program three months after the procedure.

Also known as: cardiovascular rehabilitation

Cardiovascular rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Related Publications (3)

• 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.

  PMID: 26756766 BACKGROUND

• 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.

  PMID: 30606665 BACKGROUND

• 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.

  PMID: 31495389 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michaela Enzmann, MD

  Department of Vascular Surgery, Medical University of Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela Enzmann, MD

CONTACT

+43 50504 22587; michaela.enzmann@i-med.ac.at

Angelika Gratl

CONTACT

+43 50504 22587; angelika.gratl@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP