Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05375292
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2022-05-05
Brief Title:
Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPOP-AORTA
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 patients 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 20 Euro Qol EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative
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 patients 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 20 Euro Qol EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None