Abdominal Aortic Aneurysm
Conditions
Keywords
cardiovascular rehabilitation, abdominal aortic aneurysm, endovascular aortic repair, open aortic repair
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.
Interventions
OTHERStructured 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.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of VO2max | Before the procedure and 1 year after aortic repair | Maximal oxygen uptake |
| 6-minute walking distance (6MWD) | Before the procedure and 1 year after aortic repair | Walking distance after 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the results of the The Short Form (36) Health Survey (SF-36) questionnaire | 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 |
| Surgery related complications and reoperations | After 30 days and after 1 year after aortic repair. | Number of surgically related complications and reoperations |
| 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. | 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. |
| Major adverse cardiovascular events (MACE) | 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 |
| Serum lipid profile | Blood pressure and serum lipid profile preoperative and 1 year after aortic repair. | — |
Contacts
CONTACTMichaela Enzmann, MD
CONTACTAngelika Gratl
PRINCIPAL_INVESTIGATORMichaela Enzmann, MD
Department of Vascular Surgery, Medical University of Innsbruck, Austria
Outcome results
None listed