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Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months (PREHAB-COURT)

Primary Purpose

Thoracic Diseases, Urologic Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short term prehabilitation (2 weeks)
No specific intervention
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracic Diseases focused on measuring prehabilitation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Short prehabilitation

    No prehabilitation

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
    Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters)
    Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (Borg scale)
    Change in the Borg scale (exertion from 0 to 10: 0 meaning no exertion, 10 meaning maximal exertion)

    Secondary Outcome Measures

    Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment
    VO2 Max Testing, measured in milliliters of oxygen used in one minute per kilogram of body weight (milliliter per kilogram per minute).
    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
    Evolution of Maximal Voluntary Ventilation (MVV in liter per minute).
    Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Evolution of Vital Capacity (VC in liter)
    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
    Evolution of Functional residual capacity (FRC in milliliter per kilogram).
    Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Heart rate at 40 watt during a cardiac stress test (beats per minute).
    Evaluated the change in the muscular mass of patient following a short prehabilitation at 15 days compared to the initial assessment
    Quadriceps area in square centimeters.
    Evaluated the change in the muscular strength of patient following a short prehabilitation at 15 days compared to the initial assessment
    Hand grip Test (measure in Newton).
    Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Weight in kilogram.
    Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Percentage of lean mass.
    Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 15 days compared to the initial assessment
    SF-36 quality of life scale (eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state).
    Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Hospital Anxiety and Depression Scale (HADS)(a fourteen item scale that generates : Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression).
    Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS) : PROMIS Fatigue-Short Form (seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week on a 5-point Likert scale, ranging from 1 = never to 5 = always).
    Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Sleep Disturbance-Short Form (eight items that measure both the experience problems with sleep and the interference of problems with sleep on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Pain Interference - Short Form (six items that measure both the experience of pain and the interference of pain on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Geriatric health status screening tool (G8 score) (8 questions score between 0 and 17, a higher score indicates a better health status). For geriatric patient only.
    Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Instrumental activities of daily living scale (8 domains of function ranges from 0 (low function, dependent) to 8 (high function, independent))
    Evaluate compliance to the prehabilitation program
    Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance).
    Evaluate post-surgery complications (classification)
    Classification of complications according to Dindo and Clavien (grades I, II, IIIa, IIIb, IVa, IVb or V).
    Evaluate post-surgery complications (length of stay)
    Length of stay in hospital, in intensive care unit or continuous monitoring unit (number of days).
    Evaluate post-surgery complications (mortality)
    Hospital and 30-day mortality (patient status).
    Evaluate post-surgery complications (re-hospitalization)
    Re-hospitalization in the same hospital within 30 days of discharge from the initial hospitalization (yes/no).
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (ARISCAT)
    ARISCAT score (risk of postoperative respiratory complication considered to be low for a score less than 26, moderate for a score of 26 to 44, and high for a score of 45 or more).
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (LEE)
    LEE score (postoperative cardiac risk (infarction, heart failure, death): 0-1 low risk, 2 significant risk, more than 3 major risk).
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSPOM)
    Preoperative Score To Predict Postoperative Mortality (POSPOM) system (scale of 0 to 50 points, with 0 given to patients with the lowest risk).
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (Charlson index)
    Charlson index (22 conditions are assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. A higher score indicates a higher risk of mortality.)
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSSUM score)
    Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity score (POSSUM score) (18 factors scored exponentially increasing from 1 to 8. A higher score indicates a higher risk of mortality).
    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
    Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters).
    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
    VO2 Max Testing, measured in milliliters of oxygen used in one minute per kilogram of body weight (milliliter per kilogram per minute).
    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
    Evolution of Maximal Voluntary Ventilation (MVV in liter per minute).
    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
    Evolution of Vital Capacity (VC in liter).
    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
    Evolution of Functional residual capacity (FRC in milliliter per kilogram).
    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
    Heart rate at 40 watt during a cardiac stress test (beats per minute).
    Evaluated the change in the muscular mass of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Quadriceps area in square centimeters.
    Evaluated the change in the muscular strength of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Hand grip Test (measure in Newton).
    Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Weight in kilogram.
    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
    Percentage of lean mass.
    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
    SF-36 quality of life scale (eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state).
    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
    Hospital Anxiety and Depression Scale (HADS) (a fourteen item scale that generates : Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression).
    Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS) : PROMIS Fatigue-Short Form (seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week on a 5-point Likert scale, ranging from 1 = never to 5 = always).
    Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Sleep Disturbance-Short Form (eight items that measure both the experience problems with sleep and the interference of problems with sleep on daily activities over the past week, ranging from 1 = not at all to 5 = very much)
    Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Pain Interference - Short Form (six items that measure both the experience of pain and the interference of pain on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    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
    Geriatric health status screening tool (G8 score) (8 questions score between 0 and 17, a higher score indicates a better health status). For geriatric patient only.
    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
    Instrumental activities of daily living scale (8 domains of function ranges from 0 (low function, dependent) to 8 (high function, independent)).
    Evaluated the compliance to the prehabilitation program
    Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance)

    Full Information

    First Posted
    February 14, 2020
    Last Updated
    August 2, 2022
    Sponsor
    Hopital Foch
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04351815
    Brief Title
    Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months
    Acronym
    PREHAB-COURT
    Official Title
    Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months: a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    As the possible regulatory deadline for the research was exceeded, due to logistical difficulties in setting up the study, and in agreement with the sponsor and the principal investigator, it was decided not to extend the study.
    Study Start Date
    December 20, 2019 (Actual)
    Primary Completion Date
    March 11, 2022 (Actual)
    Study Completion Date
    March 11, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hopital Foch

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Diseases, Urologic Diseases
    Keywords
    prehabilitation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Short prehabilitation
    Arm Type
    Experimental
    Arm Description
    This arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support.
    Arm Title
    No prehabilitation
    Arm Type
    Other
    Arm Description
    This arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Short term prehabilitation (2 weeks)
    Intervention Description
    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
    Other
    Intervention Name(s)
    No specific intervention
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
    Description
    Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters)
    Time Frame
    7 months
    Title
    Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (Borg scale)
    Description
    Change in the Borg scale (exertion from 0 to 10: 0 meaning no exertion, 10 meaning maximal exertion)
    Time Frame
    7 months
    Secondary Outcome Measure Information:
    Title
    Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    VO2 Max Testing, measured in milliliters of oxygen used in one minute per kilogram of body weight (milliliter per kilogram per minute).
    Time Frame
    15 days
    Title
    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
    Description
    Evolution of Maximal Voluntary Ventilation (MVV in liter per minute).
    Time Frame
    15 days
    Title
    Evaluated the change in cardio-respiratory capacity (spirometry: vital capacity) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Evolution of Vital Capacity (VC in liter)
    Time Frame
    15 days
    Title
    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
    Description
    Evolution of Functional residual capacity (FRC in milliliter per kilogram).
    Time Frame
    15 days
    Title
    Evaluated the change in cardio-respiratory capacity (heart rate) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Heart rate at 40 watt during a cardiac stress test (beats per minute).
    Time Frame
    15 days
    Title
    Evaluated the change in the muscular mass of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Quadriceps area in square centimeters.
    Time Frame
    15 days
    Title
    Evaluated the change in the muscular strength of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Hand grip Test (measure in Newton).
    Time Frame
    15 days
    Title
    Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Weight in kilogram.
    Time Frame
    15 days
    Title
    Evaluated the change in the body mass (lean mass) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Percentage of lean mass.
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (quality of life) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    SF-36 quality of life scale (eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state).
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (anxiety and depression) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Hospital Anxiety and Depression Scale (HADS)(a fourteen item scale that generates : Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression).
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS) : PROMIS Fatigue-Short Form (seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week on a 5-point Likert scale, ranging from 1 = never to 5 = always).
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Sleep Disturbance-Short Form (eight items that measure both the experience problems with sleep and the interference of problems with sleep on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Pain Interference - Short Form (six items that measure both the experience of pain and the interference of pain on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (geriatric health) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Geriatric health status screening tool (G8 score) (8 questions score between 0 and 17, a higher score indicates a better health status). For geriatric patient only.
    Time Frame
    15 days
    Title
    Evaluated the change on the psychological state (daily living) of patient following a short prehabilitation at 15 days compared to the initial assessment
    Description
    Instrumental activities of daily living scale (8 domains of function ranges from 0 (low function, dependent) to 8 (high function, independent))
    Time Frame
    15 days
    Title
    Evaluate compliance to the prehabilitation program
    Description
    Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance).
    Time Frame
    15 days
    Title
    Evaluate post-surgery complications (classification)
    Description
    Classification of complications according to Dindo and Clavien (grades I, II, IIIa, IIIb, IVa, IVb or V).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications (length of stay)
    Description
    Length of stay in hospital, in intensive care unit or continuous monitoring unit (number of days).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications (mortality)
    Description
    Hospital and 30-day mortality (patient status).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications (re-hospitalization)
    Description
    Re-hospitalization in the same hospital within 30 days of discharge from the initial hospitalization (yes/no).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (ARISCAT)
    Description
    ARISCAT score (risk of postoperative respiratory complication considered to be low for a score less than 26, moderate for a score of 26 to 44, and high for a score of 45 or more).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (LEE)
    Description
    LEE score (postoperative cardiac risk (infarction, heart failure, death): 0-1 low risk, 2 significant risk, more than 3 major risk).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSPOM)
    Description
    Preoperative Score To Predict Postoperative Mortality (POSPOM) system (scale of 0 to 50 points, with 0 given to patients with the lowest risk).
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (Charlson index)
    Description
    Charlson index (22 conditions are assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. A higher score indicates a higher risk of mortality.)
    Time Frame
    2 months and 6 months
    Title
    Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSSUM score)
    Description
    Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity score (POSSUM score) (18 factors scored exponentially increasing from 1 to 8. A higher score indicates a higher risk of mortality).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Change on the 6-minute walk test (distance covered over a time of 6 minutes in meters).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    VO2 Max Testing, measured in milliliters of oxygen used in one minute per kilogram of body weight (milliliter per kilogram per minute).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Evolution of Maximal Voluntary Ventilation (MVV in liter per minute).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Evolution of Vital Capacity (VC in liter).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Evolution of Functional residual capacity (FRC in milliliter per kilogram).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Heart rate at 40 watt during a cardiac stress test (beats per minute).
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change in the muscular mass of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Quadriceps area in square centimeters.
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change in the muscular strength of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Hand grip Test (measure in Newton).
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Weight in kilogram.
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Percentage of lean mass.
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    SF-36 quality of life scale (eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Hospital Anxiety and Depression Scale (HADS) (a fourteen item scale that generates : Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression).
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS) : PROMIS Fatigue-Short Form (seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week on a 5-point Likert scale, ranging from 1 = never to 5 = always).
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Sleep Disturbance-Short Form (eight items that measure both the experience problems with sleep and the interference of problems with sleep on daily activities over the past week, ranging from 1 = not at all to 5 = very much)
    Time Frame
    2 months and 6 months
    Title
    Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 2 and 6 months compared to the initial assessment
    Description
    Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS Pain Interference - Short Form (six items that measure both the experience of pain and the interference of pain on daily activities over the past week, ranging from 1 = not at all to 5 = very much).
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Geriatric health status screening tool (G8 score) (8 questions score between 0 and 17, a higher score indicates a better health status). For geriatric patient only.
    Time Frame
    2 months and 6 months
    Title
    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
    Description
    Instrumental activities of daily living scale (8 domains of function ranges from 0 (low function, dependent) to 8 (high function, independent)).
    Time Frame
    2 months and 6 months
    Title
    Evaluated the compliance to the prehabilitation program
    Description
    Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance)
    Time Frame
    2 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Morgan Le Guen, MD
    Organizational Affiliation
    Hopital Foch
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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