Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm (EPOP-AORTA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Other: PREHABILITATION

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélien Hostalrich, MD; Phone Number: 05 61 32 26 20; Email: hostalrich.a@chu-toulouse.fr
• Study Contact Backup: Name: Virgile Pinelli, MD; Phone Number: 05 61 32 26 20; Email: pinelli.v@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • UH Toulouse
    • Contact: Aurélien Hostalrich, MD; Phone Number: 0561322620; Email: hostalrich.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PREHABILITATION GROUP; Initial visit with the adaptive rehabilitation physician, 6-8 weeks prior to surgery: Clinical examination with Wood classification description of impairments, activity limits and participation restrictions.; Assessment of environmental resources; Definition with the patient of the extended ambulatory pre-habilitation protocol, identification with the post-operative rehabilitation pathway,; Provide the patient with a follow-up workbook of the personalized pre-approval protocol and, if the patient's condition requires it, orders for physiotherapy. Then apply the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician. - Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up). Mail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.	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.
No Intervention: CONTROL GROUP; Support without pre-approval with application of other common practices of the service. Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up). Mail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Aurélien Hostalrich, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; prehabilitation; physical therapy; open surgery; aaa
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: RC31/21/0618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No