Clinical trial NCT05375292: Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm
Official title: Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: aaa
prehabilitation
quality of life
physical therapy
open surgery
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, interventional, randomized, controlled, open study.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: functional WHODAS 2.0 score
timeFrame: T0 : Right after the open surgery for AAA
measure: functional WHODAS 2.0 score
timeFrame: 3 months after the open surgery for AAA
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Uh Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Aurélien Hostalrich, MD
role: PRINCIPAL_INVESTIGATOR
References: