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

NCT ID: NCT05375292

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2025-06-30

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Group Type: EXPERIMENTAL

PREHABILITATION

Intervention Type: OTHER

Customized program made by the physical therapist based on the first visit.

It includes 3 parts :

1. Nutrition advices that ensures adequate caloric and protein intake to support muscle anabolism

2. Muscle building over a few sessions with a physiotherapist to learn exercises and then independently redo them

3. Cardio-respiratory endurance exercises.

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 WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PREHABILITATION

Customized program made by the physical therapist based on the first visit.

It includes 3 parts :

1. Nutrition advices that ensures adequate caloric and protein intake to support muscle anabolism

2. Muscle building over a few sessions with a physiotherapist to learn exercises and then independently redo them

3. Cardio-respiratory endurance exercises.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélien Hostalrich, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Uh Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aurélien Hostalrich, MD

Role: CONTACT

hostalrich.a@chu-toulouse.fr

05 61 32 26 20

Virgile Pinelli, MD

Role: CONTACT

pinelli.v@chu-toulouse.fr

05 61 32 26 20

Facility Contacts

Aurélien Hostalrich, MD

Role: primary

hostalrich.a@chu-toulouse.fr

0561322620

Other Identifiers

RC31/21/0618

Identifier Type: -

Identifier Source: org_study_id