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Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm

Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05375292
Acronym
EPOP-AORTA
Enrollment
60
Registered
2022-05-16
Start date
2022-12-06
Completion date
2025-06-30
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

aaa, prehabilitation, quality of life, physical therapy, open surgery

Brief summary

This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

Detailed description

Open surgery of abdominal aortic aneurysms (AAA) is the reference treatment in a large number of cases. This is a heavy procedure performed in patients around 70 years of age. In post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients. The goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living. The pre-habilitation protocol includes 3 parts : 1. Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism 2. Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently 3. Cardio-respiratory endurance. For the experimental group: Initial visit with adaptive rehabilitation physician, 6-8 weeks prior to surgery: * Clinical examination with Wood classification - limits and restrictions. * Assessment of environmental resources * Definition pre-habilitation protocol and post-operative rehabilitation pathway * application of the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician. For the control group: Support without pre-approval with application of other common practices of the service. Follow up of both groups: Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up). Mail-out of World Health Organisation Disability Assessment Schedule (WHODAS) 2.0, Euro Qol (EQ)-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Interventions

OTHERPREHABILITATION

Customized program made by the physical therapist based on the first visit. It includes 3 parts : 1. Nutrition advices that ensures adequate caloric and protein intake to support muscle anabolism 2. Muscle building over a few sessions with a physiotherapist to learn exercises and then independently redo them 3. Cardio-respiratory endurance exercises.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Monocentric, interventional, randomized, controlled, open study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Supra renal/Juxta-renal/Sub renal) treated with conventional surgery. * Surgical indication of aneurysm by size (50-55mm)

Exclusion criteria

\- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.

Design outcomes

Primary

MeasureTime frameDescription
functional WHODAS 2.0 scoreT0 : Right after the open surgery for AAAthe WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities

Countries

France

Contacts

Primary ContactAurélien Hostalrich, MD
hostalrich.a@chu-toulouse.fr05 61 32 26 20
Backup ContactVirgile Pinelli, MD
pinelli.v@chu-toulouse.fr05 61 32 26 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026