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Withdrawn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
About this trial
This is an interventional prevention trial for Thoracic Diseases focused on measuring prehabilitation
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.
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
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
We'll reach out to this number within 24 hrs