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

NCT05375292 | Recruiting

• 1 other identifier: RC31/21/0618
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

aaa; prehabilitation; quality of life; physical therapy; open surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Interventions

PREHABILITATION OTHER

Customized 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.

PREHABILITATION GROUP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Uh Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Alzheimer Disease

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aurélien Hostalrich, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, interventional, randomized, controlled, open study.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: December 6, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)