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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.
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 :
For the experimental group:
Initial visit with adaptive rehabilitation physician, 6-8 weeks prior to surgery:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREHABILITATION GROUP | Experimental | Initial visit with the adaptive rehabilitation physician, 6-8 weeks prior to surgery:
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. |
|
| CONTROL GROUP | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREHABILITATION | Other | Customized program made by the physical therapist based on the first visit. It includes 3 parts :
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | T0 : Right after the open surgery for AAA |
| 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 | 3 months after the open surgery for AAA |
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Inclusion Criteria:
Exclusion Criteria:
- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélien Hostalrich, MD | Contact | 05 61 32 26 20 | hostalrich.a@chu-toulouse.fr | |
| Virgile Pinelli, MD | Contact | 05 61 32 26 20 | pinelli.v@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aurélien Hostalrich, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uh Toulouse | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Monocentric, interventional, randomized, controlled, open study.
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|
| D001018 |
| Aortic Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |