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

Last updated: July 17, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

PREHABILITATION

Clinical Study ID

NCT05375292
RC31/21/0618
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Suprarenal/Juxta-renal/Sub renal) treated with conventional surgery.

  • Surgical indication of aneurysm by size (50-55mm)

Exclusion

Exclusion Criteria:

  • Patient requiring urgent management that does not allow for a pre-authorisationprotocol of at least 6 weeks.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: PREHABILITATION
Phase:
Study Start date:
December 06, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Uh Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

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