Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months

NCT ID: NCT04351815

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2022-03-11

Brief Summary

This study aimed to evaluated the interest of a short-term (2 weeks) prehabilitation program compared to no prehabilitation before thoracic or urological surgery

Detailed Description

Prehabilitation is a form of global strength training, aims to improve functional capacity before surgery.This preparation compensate for its decrease due to the intervention. This process includes physical training, nutritional and psychological care.

Previous studies consider 4 weeks to be the ideal duration time for such program. However, extended program duration may reduce subject compliance and may not be possible for patient who can not or do not want to postponed their surgery.

Conditions

Thoracic Diseases; Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Short prehabilitation

This arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support.

Group Type: EXPERIMENTAL

Short term prehabilitation (2 weeks)

Intervention Type: BEHAVIORAL

• Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
• Patient will be asked to follow a 2 weeks prehabilitation program
• 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
• 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)

No prehabilitation

This arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support.

Group Type: OTHER

No specific intervention

Intervention Type: OTHER

• Standard care: Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
• Patients will be asked to maintain regular physical activity without support
• 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
• 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)

Interventions

Short term prehabilitation (2 weeks)

• Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
• Patient will be asked to follow a 2 weeks prehabilitation program
• 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
• 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)

Intervention Type: BEHAVIORAL

No specific intervention

• Standard care: Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
• Patients will be asked to maintain regular physical activity without support
• 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
• 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men or women aged 55 or over
• Requiring major surgery (thoracic or urological surgery: kidney or bladder) within 15 days after the completion of the inclusion assessment
• Having signed a consent form after a reflection period
• Being affiliated to a Health Insurance plan.

Exclusion Criteria

• Pregnant, parturient or lactating women
• Persons deprived of their liberty: minors or adults subject to legal protection measures or out of state to express their consent
• Patients (men or women) aged <55 years;
• Inability to walk or initial physical assessment
• Inability to complete questionnaires
• Walk> 450 meters in the 6 minute test
• Patients under guardianship or curators.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Other Identifiers

2019_0011

Identifier Type: -

Identifier Source: org_study_id