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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiovascular rehabilitation | Experimental | This group receives a three-week inpatient cardiovascular rehabilitation program three months after the procedure. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Michaela Enzmann, MD | Department of Vascular Surgery, Medical University of Innsbruck, Austria | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26756766 | Background | 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. | |
| 30606665 | 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. |
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Study relevant pseudonymized IPD will be shared by the study team upon reasonable request.
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Randomized controlled trial
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|
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. |
| 31495389 | 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. |
| D001018 |
| Aortic Diseases |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |