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Clinical Trials/NCT05375292
NCT05375292
Recruiting
N/A

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

University Hospital, Toulouse1 site in 1 country60 target enrollmentDecember 6, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm
Sponsor
University Hospital, Toulouse
Enrollment
60
Locations
1
Primary Endpoint
functional WHODAS 2.0 score
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2022
End Date
June 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

functional WHODAS 2.0 score

Time Frame: 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

Study Sites (1)

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