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Not yet recruiting NCT07690046

Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair

No phase Interventional Abdominal Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured cardiovascular rehabilitation.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Other Structured 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.

Primary outcome measures

  • Change of VO2max [Time frame: Before the procedure and 1 year after aortic repair]
  • 6-minute walking distance (6MWD) [Time frame: Before the procedure and 1 year after aortic repair]
Secondary outcome measures (6)
  • 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]
  • Surgery 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 [Time frame: Preoperative and 1 year after aortic repair.]
  • Major adverse cardiovascular events (MACE) [Time frame: 30 days and 1 year after aortic repair.]
  • Serum lipid profile [Time frame: Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07690046 · EK Nr: 1128/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗