Clinical trial NCT04351815: Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months
Official title: Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thoracic Diseases
Urologic Diseases
Keywords: prehabilitation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
timeFrame: 7 months
measure: Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (Borg scale)
timeFrame: 7 months
Secondary outcomes:
measure: Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in cardio-respiratory capacity (spirometry: maximal voluntary ventilation) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in cardio-respiratory capacity (spirometry: functional residual capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in the muscular mass of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in the muscular strength of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 15 days compared to the initial assessment
timeFrame: 15 days
measure: Evaluate compliance to the prehabilitation program
timeFrame: 15 days
measure: Evaluate post-surgery complications (classification)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications (length of stay)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications (mortality)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications (re-hospitalization)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications : comparison between predicted complications and actual complications (ARISCAT)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications : comparison between predicted complications and actual complications (LEE)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSPOM)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications : comparison between predicted complications and actual complications (Charlson index)
timeFrame: 2 months and 6 months
measure: Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSSUM score)
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (6 minutes walk test) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (spirometry: maximal voluntary ventilation) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (spirometry: functional residual capacity) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in the muscular mass of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in the muscular strength of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
timeFrame: 2 months and 6 months
measure: Evaluated the compliance to the prehabilitation program
timeFrame: 2 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References: