Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair

N/ANot Yet RecruitingNCT07690046

Medical University Innsbruck40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysm

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of VO2max

Maximal oxygen uptake

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

6-minute walking distance (6MWD)

Walking distance after 6 minutes

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

Secondary Outcomes

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

Time frame: Before surgery and 1 year after aortic repair

Surgery related complications and reoperations

Number of surgically related complications and reoperations

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

Change of blood pressure

Time frame: 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.

Time frame: 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

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

Serum lipid profile