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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05375292

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Other: PREHABILITATION	N/A

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 :

Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism
Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently
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 WHODAS 2.0, EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Monocentric, interventional, randomized, controlled, open study.Monocentric, interventional, randomized, controlled, open study.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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 WHODAS2.0 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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

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 WHODAS2.0 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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Outcome Measures

Primary Outcome Measures

functional WHODAS 2.0 score [T0 : Right after the open surgery for AAA]
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
functional WHODAS 2.0 score [T3M : 3 months after the open surgery for AAA]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)