Abdominal Aortic AneurysmREHAB-AAANCT07690046
Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair
A study testing Structured cardiovascular rehabilitation in people with Abdominal Aortic Aneurysm, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Structured cardiovascular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an abdominal aortic aneurysm (AAA) and an indication for repair, ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Acute AAA repair
- AAA size ≥7cm
- Para/suprarenal AAA
- AAA due to a connective tissue disorder
- Impaired mobility
- Life expectancy <12 months
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Medical University Innsbruck
Innsbruck, Tyrol, 6020
Michaela Enzmann, MD, +43 50504 22587, michaela.enzmann@i-med.ac.at
About this study
Official title: Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair-REHAB-AAA, a Randomised Controlled Pilot Study
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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Structured cardiovascular rehabilitation
- Keywords
- cardiovascular rehabilitation, abdominal aortic aneurysm, endovascular aortic repair, open aortic repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured cardiovascular rehabilitationOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular rehabilitation | Experimental | This group receives a three-week inpatient cardiovascular rehabilitation program three months after the procedure. Receives: Other: Structured cardiovascular rehabilitation |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VO2max
Maximal oxygen uptake
Measured: Before the procedure and 1 year after aortic repair
6-minute walking distance (6MWD)
Walking distance after 6 minutes
Measured: Before the procedure and 1 year after aortic repair
Secondary outcomes (6)
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
Measured: Before surgery and 1 year after aortic repair
Surgery related complications and reoperations
Number of surgically related complications and reoperations
Measured: After 30 days and after 1 year after aortic repair.
Change of blood pressure
Measured: 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.
Measured: 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
Measured: 30 days and 1 year after aortic repair.
Serum lipid profile
Measured: Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Oct 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaela Enzmann, MD, Principal investigator, Department of Vascular Surgery, Medical University of Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690046
- Sponsor's protocol ID
- EK Nr: 1128/2026
- Acronym
- REHAB-AAA
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study relevant pseudonymized IPD will be shared by the study team upon reasonable request.
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.
PubMed 26756766Wee 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.
PubMed 30606665Aronov 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.
PubMed 31495389
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair-REHAB-AAA, a Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07690046
- Acronym / sponsor ID
- REHAB-AAA / EK Nr: 1128/2026
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- cardiovascular rehabilitation, abdominal aortic aneurysm, endovascular aortic repair, open aortic repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular rehabilitation | Experimental | Other: Structured cardiovascular rehabilitationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an abdominal aortic aneurysm (AAA) and an indication for repair, ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Acute AAA repair
- AAA size ≥7cm
- Para/suprarenal AAA
- AAA due to a connective tissue disorder
- Impaired mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured cardiovascular rehabilitationAlso: cardiovascular rehabilitationParticipants after open or endovascular abdominal aortic aneurysm repair will receive a three-week inpatient structured cardiovascular rehabilitation program three months after the procedure. | Other | Cardiovascular rehabilitation |
Primary outcome
Change of VO2max
Time frame: Before the procedure and 1 year after aortic repair
Maximal oxygen uptake
6-minute walking distance (6MWD)
Time frame: Before the procedure and 1 year after aortic repair
Walking distance after 6 minutes
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 26756766Barakat 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.
- Background: PubMed 30606665Wee 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.
- Background: PubMed 31495389Aronov 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.
- Individual participant dataSharing planned: Yes. Study relevant pseudonymized IPD will be shared by the study team upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michaela Enzmann, MD principal investigator
Department of Vascular Surgery, Medical University of Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured cardiovascular rehabilitation in people with Abdominal Aortic Aneurysm, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela Enzmann, MD (+43 50504 22587, michaela.enzmann@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VO2max (time frame: Before the procedure and 1 year after aortic repair). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07690046, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.