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NCT Number: NCT05375292

Evaluation of the Impact of Prehabilitation on Recovery Following 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.

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Key information

Conditions

Abdominal Aortic Aneurysm Alzheimer Disease Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uh Toulouse

Toulouse, 31059, France

Location status: Recruiting

Location contact

Aurélien Hostalrich, MD

CONTACT

[email protected]

0561322620

About this study

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 World Health Organisation Disability Assessment Schedule (WHODAS) 2.0, Euro Qol (EQ)-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prehabilitation

Other

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.

Primary outcomes

  1. functional WHODAS 2.0 score

    Time frame: 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

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Aurélien Hostalrich, MD

CONTACT

[email protected]

05 61 32 26 20

Virgile Pinelli, MD

CONTACT

[email protected]

05 61 32 26 20

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: EPOP-AORTA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 16, 2022
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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