Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID05375292

Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm

Led by University Hospital, Toulouse · Updated on 2024-07-18

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a prehabilitation program on recovery after open surgery for abdominal aortic aneurysm (AAA). This study is a pilot, prospective, randomized control trial aiming to estimate the functional recovery over three months post-surgery between patients who undergo outpatient prehabilitation and those who do not. Open surgery for AAA is a major procedure often performed in patients around 70 years old, with a focus on improving overall functional status to maintain independence in daily activities. The prehabilitation program includes three parts: nutritional advice to ensure adequate caloric and protein intake, muscle-building sessions with a physiotherapist to teach exercises for independent practice, and cardio-respiratory endurance exercises. Participants in the experimental group meet with an adaptive rehabilitation physician 6-8 weeks before surgery to define a personalized prehabilitation protocol and post-operative rehabilitation plan. The control group receives usual care without the prehabilitation protocol. Both groups have post-operative follow-up visits with the surgeon. Participants will complete questionnaires assessing disability and quality of life (WHODAS 2.0, Euro Qol EQ-5D-5L, and DIJON) at 3 and 6 months after surgery. Functional recovery is measured using the WHODAS 2.0 score immediately after surgery and at 3 months post-operatively. The study is sponsored by University Hospital, Toulouse, and participants are followed throughout these time points to compare outcomes between groups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
  • Age between 18 and 100 years
Not Eligible

You will not qualify if you...

  • Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Prehabilitation

Duration - 6 to 8 weeks prior to surgery

Participants in the experimental group meet with an adaptive rehabilitation physician 6 to 8 weeks prior to surgery to define a personalized prehabilitation protocol including nutrition advice, muscle building exercises, and cardio-respiratory endurance training.

1 initial visit with adaptive rehabilitation physician and several physiotherapy sessions

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo open surgery for abdominal aortic aneurysm followed by immediate postoperative care.

1 surgical procedure and immediate post-operative care visits

Post-operative Follow-up

Duration - 6 months post-operative

Participants attend follow-up visits with the surgeon and complete mailed questionnaires assessing functional status and quality of life at 3 and 6 months after surgery.

Follow-up visits with surgeon and questionnaires mailed at 3 and 6 months post-operative

Trial Site Locations

Total: 1 location

1

Uh Toulouse

Toulouse, France, 31059

Actively Recruiting

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Research Team

A

Aurélien Hostalrich, MD

V

Virgile Pinelli, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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