Thoracic DiseasesPREHAB-COURTNCT04351815
Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months
A study testing Short term prehabilitation (2 weeks) and No specific intervention in people with Thoracic Diseases and Urologic Diseases, run by Hopital Foch.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Thoracic Diseases, Urologic Diseases
- What is being tested?
- Short term prehabilitation (2 weeks) and No specific intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2019to 11 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
Read the detailed description
Prehabilitation is a form of global strength training, aims to improve functional capacity before surgery.This preparation compensate for its decrease due to the intervention. This process includes physical training, nutritional and psychological care.
Previous studies consider 4 weeks to be the ideal duration time for such program. However, extended program duration may reduce subject compliance and may not be possible for patient who can not or do not want to postponed their surgery.
- Conditions
- Thoracic Diseases, Urologic Diseases
- Being tested
- Short term prehabilitation (2 weeks), No specific intervention
- Keywords
- prehabilitation
- Medical subject headings
- Thoracic Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short term prehabilitation (2 weeks)Behavioural
- Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
- Patient will be asked to follow a 2 weeks prehabilitation program
- 2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
- 6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
No specific interventionOther
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Short prehabilitation | Experimental | This arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support. Receives: Behavioral: Short term prehabilitation (2 weeks) |
| No prehabilitation | Other | This arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support. Receives: Other: No specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 7 months
Secondary outcomes (44)
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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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))
Measured: 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).
Measured: 15 days
Evaluate post-surgery complications (classification)
Classification of complications according to Dindo and Clavien (grades I, II, IIIa, IIIb, IVa, IVb or V).
Measured: 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).
Measured: 2 months and 6 months
Evaluate post-surgery complications (mortality)
Hospital and 30-day mortality (patient status).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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)).
Measured: 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)
Measured: 2 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 Dec 2019
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351815
- Sponsor's protocol ID
- 2019_0011
- Acronym
- PREHAB-COURT
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Prehabilitation Program : Interest of on Resumption of Function at 2 Months: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04351815
- Acronym / sponsor ID
- PREHAB-COURT / 2019_0011
- Conditions
- Thoracic Diseases, Urologic Diseases
- Keywords
- prehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short prehabilitation | Experimental | Behavioral: Short term prehabilitation (2 weeks)This arm will benefit from a 2 weeks prehabilitation program including a personalized dietetic and physical training program as well as psychological support. |
| No prehabilitation | Other | Other: No specific interventionThis arm will not benefit from a prehabilitation program before surgery. Patients will be told to maintain a regular physical activity without support. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Short prehabilitation |
| 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) | Other | No prehabilitation |
Primary outcome
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test)
Time frame: 7 months
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)
Time frame: 7 months
Change in the Borg scale (exertion from 0 to 10: 0 meaning no exertion, 10 meaning maximal exertion)
44 secondary outcomes
Evaluated the change in cardio-respiratory capacity (VO2 max) of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 15 days
Evaluated the change in the muscular mass of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 15 days
Evaluated the change in the muscular strength of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 15 days
Evaluated the change in the body mass (weight) of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 15 days
Evaluated the change on the psychological state (fatigue) of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 15 days
Evaluated the change on the psychological state (sleep) of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 15 days
Evaluated the change on the psychological state (pain) of patient following a short prehabilitation at 15 days compared to the initial assessment
Time frame: 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
Time frame: 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
Time frame: 15 days
Evaluate compliance to the prehabilitation program
Time frame: 15 days
Evaluate post-surgery complications (classification)
Time frame: 2 months and 6 months
Evaluate post-surgery complications (length of stay)
Time frame: 2 months and 6 months
Evaluate post-surgery complications (mortality)
Time frame: 2 months and 6 months
Evaluate post-surgery complications (re-hospitalization)
Time frame: 2 months and 6 months
Evaluate post-surgery complications : comparison between predicted complications and actual complications (ARISCAT)
Time frame: 2 months and 6 months
Evaluate post-surgery complications : comparison between predicted complications and actual complications (LEE)
Time frame: 2 months and 6 months
Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSPOM)
Time frame: 2 months and 6 months
Evaluate post-surgery complications : comparison between predicted complications and actual complications (Charlson index)
Time frame: 2 months and 6 months
Evaluate post-surgery complications : comparison between predicted complications and actual complications (POSSUM score)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Related trials for Thoracic Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Le Guen, MD principal investigator
Hopital Foch
Questions about this trial
What is this clinical trial studying?
A study testing Short term prehabilitation (2 weeks) and No specific intervention in people with Thoracic Diseases and Urologic Diseases, run by Hopital Foch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluated the change in physical condition of patient following a short prehabilitation compared to the initial assessment (6 minutes walk test) (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.