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

Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months: a Randomized Controlled Study

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

Study Overview

• Status: Withdrawn
• Conditions: Urologic Diseases; Thoracic Diseases
• Intervention / Treatment: Behavioral: Short term prehabilitation (2 weeks); Other: No specific intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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)
OTHER: 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.	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 months
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)	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 days
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).	15 days
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)	15 days
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).	15 days
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).	15 days
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.	15 days
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).	15 days
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.	15 days
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.	15 days
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).	15 days
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).	15 days
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).	15 days
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).	15 days
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).	15 days
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.	15 days
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))	15 days
Evaluate compliance to the prehabilitation program	Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance).	15 days
Evaluate post-surgery complications (classification)	Classification of complications according to Dindo and Clavien (grades I, II, IIIa, IIIb, IVa, IVb or V).	2 months and 6 months
Evaluate post-surgery complications (length of stay)	Length of stay in hospital, in intensive care unit or continuous monitoring unit (number of days).	2 months and 6 months
Evaluate post-surgery complications (mortality)	Hospital and 30-day mortality (patient status).	2 months and 6 months
Evaluate post-surgery complications (re-hospitalization)	Re-hospitalization in the same hospital within 30 days of discharge from the initial hospitalization (yes/no).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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.)	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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.	2 months and 6 months
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).	2 months and 6 months
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.	2 months and 6 months
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.	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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).	2 months and 6 months
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)	2 months and 6 months
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).	2 months and 6 months
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.	2 months and 6 months
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)).	2 months and 6 months
Evaluated the compliance to the prehabilitation program	Overall compliance score regarding physical training, proteins intake, well-being and fatigue (complete, partial or non compliance)	2 months and 6 months

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2019
• Primary Completion (ACTUAL): March 11, 2022
• Study Completion (ACTUAL): March 11, 2022

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: prehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases; Urologic Diseases
• Other Study ID Numbers: 2019_0011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No