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Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm (EPOP-AORTA)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PREHABILITATION
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Abdominal Aortic Aneurysm focused on measuring aaa, prehabilitation, quality of life, physical therapy, open surgery

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uh ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PREHABILITATION GROUP

CONTROL GROUP

Arm Description

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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.

Outcomes

Primary Outcome Measures

functional WHODAS 2.0 score
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
functional WHODAS 2.0 score
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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
January 6, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05375292
Brief Title
Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm
Acronym
EPOP-AORTA
Official Title
Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
aaa, prehabilitation, quality of life, physical therapy, open surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, interventional, randomized, controlled, open study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREHABILITATION GROUP
Arm Type
Experimental
Arm Description
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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
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 WHODAS2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.
Intervention Type
Other
Intervention Name(s)
PREHABILITATION
Intervention Description
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 Outcome Measure Information:
Title
functional WHODAS 2.0 score
Description
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
Time Frame
T0 : Right after the open surgery for AAA
Title
functional WHODAS 2.0 score
Description
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
Time Frame
T3M : 3 months after the open surgery for AAA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien Hostalrich, MD
Phone
05 61 32 26 20
Email
hostalrich.a@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Virgile Pinelli, MD
Phone
05 61 32 26 20
Email
pinelli.v@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien Hostalrich, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uh Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélien Hostalrich, MD
Phone
0561322620
Email
hostalrich.a@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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