Health TrialsbyHealthPanel

Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair

ConditionAbdominal Aortic Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with an abdominal aortic aneurysm (AAA) and an indication for repair, ability to understand and willingness to sign a written informed consent document.

Disqualifiers

Acute AAA repair

AAA size ≥7cm

Para/suprarenal AAA

AAA due to a connective tissue disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured cardiovascular rehabilitation

    Other intervention

    Participants after open or endovascular abdominal aortic aneurysm repair will receive a three-week inpatient structured cardiovascular rehabilitation program three months after the procedure.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Cardiovascular rehabilitationExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of VO2max

Maximal oxygen uptake

Time frame
Before the procedure and 1 year after aortic repair
2

6-minute walking distance (6MWD)

Walking distance after 6 minutes

Time frame
Before the procedure and 1 year after aortic repair

Secondary outcomes

1

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
2

Surgery related complications and reoperations

Number of surgically related complications and reoperations

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

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University Innsbruck

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: