Abdominal Aortic AneurysmEPOP-AORTANCT05375292
Evaluation of the Impact of Prehabilitation on Recovery Following Open Surgery for Abdominal Aortic Aneurysm
A study testing PREHABILITATION in people with Abdominal Aortic Aneurysm, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- PREHABILITATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Toulouse
Toulouse, 31059
Aurélien Hostalrich, MD, 0561322620, hostalrich.a@chu-toulouse.fr
About this study
Official title: Efficacy of Pre-Operative Prehabilitation in Patients Undergoing 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.
Read the 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 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
- Being tested
- PREHABILITATION
- Keywords
- aaa, prehabilitation, quality of life, physical therapy, open surgery
- Medical subject headings
- Aortic Aneurysm, Abdominal, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREHABILITATIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PREHABILITATION GROUP | Experimental | 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. Receives: Other: PREHABILITATION |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months after the open surgery for AAA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start6 Dec 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, interventional, randomized, controlled, open study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien Hostalrich, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375292
- Sponsor's protocol ID
- RC31/21/0618
- Acronym
- EPOP-AORTA
- Status last verified
- Jul 2024
- First submitted
- 5 May 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT05375292
- Acronym / sponsor ID
- EPOP-AORTA / RC31/21/0618
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- aaa, prehabilitation, quality of life, physical therapy, open surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 World Health Organisation Disability Assessment Schedule (WHODAS) 2.0, Euro Qol (EQ)-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, interventional, randomized, controlled, open study.
| Arm | Type | Receives |
|---|---|---|
| PREHABILITATION GROUP | Experimental | Other: PREHABILITATIONInitial 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREHABILITATIONCustomized 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. | Other | PREHABILITATION GROUP |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien Hostalrich, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREHABILITATION in people with Abdominal Aortic Aneurysm, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélien Hostalrich, MD (05 61 32 26 20, hostalrich.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional WHODAS 2.0 score (time frame: T0 : Right after the open surgery for AAA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.