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

Abdominal Aortic Aneurysm Clinical Trial

— EPOP-AORTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375292
• Other study ID #: RC31/21/0618
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Toulouse
• Contact: Aurélien Hostalrich, MD
• Phone: 05 61 32 26 20
• Email: hostalrich.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
France	Uh Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional WHODAS 2.0 score	the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities	T0 : Right after the open surgery for AAA
Primary	functional WHODAS 2.0 score	the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities	3 months after the open surgery for AAA