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NCT Number: NCT07690046

Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: cardiovascular rehabilitation

Primary outcomes

  1. Change of VO2max

    Time frame: Before the procedure and 1 year after aortic repair

    Maximal oxygen uptake

  2. 6-minute walking distance (6MWD)

    Time frame: Before the procedure and 1 year after aortic repair

    Walking distance after 6 minutes

Secondary outcomes

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

    Time frame: Before surgery and 1 year after aortic repair

    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

  2. Surgery related complications and reoperations

    Time frame: After 30 days and after 1 year after aortic repair.

    Number of surgically related complications and reoperations

  3. Change of blood pressure

    Time frame: Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.

  4. Mini-mental state examination

    Time frame: Preoperative and 1 year after aortic repair.

    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.

  5. Major adverse cardiovascular events (MACE)

    Time frame: 30 days and 1 year after aortic repair.

    Number of composite adverse cardiovascular events: non-fatal myocardial infarction, stroke, coronary and peripheral arterial disease revascularization, non-traumatic amputation

  6. Serum lipid profile

    Time frame: Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelika Gratl

CONTACT

[email protected]

+43 50504 22587

Michaela Enzmann, MD

CONTACT

[email protected]

+43 50504 22587

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: REHAB-AAA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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