Mechanical VentilationNUTRIREA-4NCT06581939
Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU
A study testing Rehabilitation group in people with Mechanical Ventilation, run by Nantes University Hospital at 52 sites in France.
Trial summary
The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Rehabilitation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 52 sitesFrance
- Study dates
- 14 Dec 2024to 14 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, and expected to be required for at least 48 hours after randomization
- Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
- Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)
- Age 18 or older
- Patient and/or next-of-kin informed about the trial and having consented to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law.
- Covered by the French public health-insurance system
Who cannot join
- MV started more than 24 hours earlier
- Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease
- Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission
- Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence)
- Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name)
- Communication difficulties via telephone or video consultation (pre-existing severe hearing or visual impairment)
Show all 17Show fewer
- Pre-existing chronic illness with life expectancy <6 months
- Pre-existing cognitive impairment
- Pre-existing spinal injury
- Inability to walk before the critical illness
- Acute or chronic neuromuscular disease
- Brain injury, e.g., due to cardiac arrest, stroke, or severe trauma
- Pregnancy, recent delivery, or lactation
- Adult under guardianship
- Correctional facility inmate
- Institutionalized patient
- Prior inclusion in a randomized trial designed to compare rehabilitation programs delivered to patients during critical illness
Trial locations and contacts
52 sites in 1 country. Contact the study team or a site near you to ask about taking part.
52 sites in 1 country
France52 sites, 52 recruiting
- Recruiting
CH d'Albi
Albi, 81013
Christophe HENRY, christophe.henry@ch-albi.fr
- Recruiting
CHU d'Amiens - Site Sud
Amiens, 80054
Julien MAIZEL, maizel.julien@chu-amiens.fr
- Recruiting
CHU d'Amiens
Amiens, 80054
Stéphanie MALAQUIN, malaquin.stephanie@chu-amiens.fr
- Recruiting
CHU d'Angers
Angers, 49933
Marc PIERROT, mapierrot@chu-angers.fr
- Recruiting
CH d'Angoulème
Angoulême, 16959
Laurent LAINE, laurent.laine@ch-angouleme.fr
- Recruiting
CH d'Argenteuil
Argenteuil, 95100
Gaëtan PLANTEFEVE, gaetan.plantefeve@ch-argenteuil.fr
- Recruiting
CH de Belfort
Belfort, 90015
Julio BADIE, julio.badie@hnfc.fr
- Recruiting
CHU de Besançon
Besançon, 25030
Gaël PITON, gpiton@chu-besancon.fr
- Recruiting
CH de Béthune
Béthune, 62408
Ghada SBOUI, gsboui@ch-bethune.fr
- Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Vivien GUILLOTIN, vivien.guillotin@chu-bordeaux.fr
- Recruiting
Centre Hospitalier William Morey
Chalon-sur-Saône, 71100
Thomas MALDINEY, +33 3 85 44 66 88, thomas.maldiney@ch-chalon71.fr
- Recruiting
CH de Cholet
Cholet, 49325
Anne-Astrid BOURION, anne-astrid.bourion@ch-cholet.fr
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Claire DUPUIS, cdupuis@chu-clermontferrand.fr
- Recruiting
CH de Dieppe
Dieppe, 76202
Jean-Philippe RIGAUD, jrigaud@ch-dieppe.fr
- Recruiting
CHU de Dijon
Dijon, 21079
Jean-Pierre QUENOT, jean-pierre.quenot@chu-dijon.fr
- Recruiting
CH d'Annecy Genevois
Épagny, 74370
Marie ROUGON, mrougon@ch-annecygenevois.fr
- Recruiting
Centre Hospitalier Sud Essonne
Étampes, 91150
Akli CHERMAK, achermak@ch-sudessonne.fr
- Recruiting
Hôpital Raymond Poincaré - AP-HP
Garches, 92380
Virginie MAXIME, virginie.maxime@aphp.fr
- Recruiting
CHU de Grenoble
Grenoble, 38043
Louis-Marie GALERNEAU, lmgalerneau@chu-grenoble.fr
- Recruiting
CH d'Haguenau
Haguenau, 67504
Quentin GEORGES, quentin.georges@ch-haguenau.fr
- Recruiting
CH de Vendée
La Roche-sur-Yon, 85925
Isabelle VINATIER, isabelle.vinatier@ght85.fr
- Recruiting
Hôpital de Bicêtre - AP-HP
Le Kremlin-Bicêtre, 94275
Laurent GUERIN, laurent.guerin@aphp.fr
- Recruiting
CH du Mans
Le Mans, 72037
Mickaël LANDAIS, mlandais@ch-lemans.fr
- Recruiting
CH de Lens
Lens, 62300
Olivier NIGEON, onigeon@ch-lens.fr
- Recruiting
CHRU de Lille
Lille, 59037
Claire BOUREL, claire.bourel@chru-lille.fr
- Recruiting
CH de Lomme
Lomme, 59462
Thierry VAN DER LINDEN, vanderlinden.thierry@ghicl.net
- Recruiting
CH de Lorient
Lorient, 56100
Béatrice LACOMBE, b.lacombe@ghbs.bzh
- Recruiting
CHU de Lyon
Lyon, 69437
Laurent ARGAUD, laurent.argaud@chu-lyon.fr
- Recruiting
CHU de Montpellier
Montpellier, 34295
Samir JABER, s-jaber@chu-montpellier.fr
- Recruiting
CHU de Nantes
Nantes, 44000
Jean REIGNIER, MD, 0240087361, jean.reignier@chu-nantes.fr
- Recruiting
CHU de Nice - Hôpital Pasteur
Nice, 06100
Matthieu BOIFFIER, boiffier.m@chu-nice.fr
- Recruiting
CHU de Nice
Nice, 06200
Clément SACCHERI, saccheri.c@chu-nice.fr
- Recruiting
CH d'Orléans
Orléans, 45100
Maxime DESGROUAS, maxime.desgrouas@chr-orleans.fr
- Recruiting
Hôpital Saint-Louis - AP-HP
Paris, 75010
Michael DARMON, michael.darmon@aphp.fr
- Recruiting
Hôpital Cochin - AP-HP
Paris, 75014
Jean-Paul MIRA, jean-paul.mira@cch.aphp.fr
- Recruiting
Hôpital la Pitié-Salpétrière - AP-HP
Paris, 75651
Elise MORAWIEC, elise.morawiec@aphp.fr
- Recruiting
Hôpital Tenon - AP-HP
Paris, 75970
BEURTON Alexandra, alexandra.beurton@aphp.fr
- Recruiting
CHU de Reims
Reims, 51092
Maxime BERTRAND, mbertrand@chu-reims.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Jean-Marc TADIE, jeanmarc.tadie@chu-rennes.fr
- Recruiting
CHU de Rouen
Rouen, 76000
Fabienne TAMION, fabienne.tamion@chu-rouen.fr
- Recruiting
CH de Saint-Brieuc
Saint-Brieuc, 22027
Mattieu DEBARRE, matthieu.debarre@ch-stbrieuc.fr
- Recruiting
Hôpital Delafontaine
Saint-Denis, 93200
Daniel SILVA, daniel.silva@ch-stdenis.fr
- Recruiting
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, 44600
Damien MULLER, mailto:d.muller@ch-saintnazaire.fr
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Guillaume THIERY, guillaume.thiery@chu-st-etienne.fr
- Recruiting
CH de Saint-Malo
St-Malo, 35403
Nicolae-Vlad BOTOC, n.botoc@ch-stmalo.fr
- Recruiting
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091
Hamid MERDJI, hamid.merdji@chru-strasbourg.fr
- Recruiting
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200
Jean-Etienne HERBRECHT, jean-etienne.herbrecht@chru-strasbourg.fr
- Recruiting
Hôpital Foch
Suresnes, 92150
Jérôme DEVAQUET, j.devaquet@hopital-foch.org
- Recruiting
CHU de Tours
Tours, 37044
Emmanuelle MERCIER, emercier@med.univ-tours.fr
- Recruiting
CH de Valenciennes
Valenciennes, 59322
Fabien LAMBIOTTE, lambiotte-f@ch-valenciennes.fr
- Recruiting
CH de Vannes
Vannes, 56017
Agathe DELBOVE, agathe.delbove@ch-bretagne-atlantique.fr
- Recruiting
CH de Verdun
Verdun, 55100
Thibault NOEL, tnoel@ch-verdun.fr
About this study
Official title: Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU : A Multicenter Randomized Controlled Trial
The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care.
From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.
- Conditions
- Mechanical Ventilation
- Being tested
- Rehabilitation group, Control group
- Keywords
- Critical care, Nutritional support, Mechanical ventilation, Shock, Macronutrients, Rehabilitation, Physiotherapy, Adapted physical activity
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation groupProcedure or surgery
In the rehabilitation group, patients will follow an individualized rehabilitation program started early in the ICU and continued in the post-ICU ward then at home for 12 weeks, combining goal-directed nutrition and physical activity, tailored to gains made over time by each patient, with the involvement of dieticians, physiotherapists, and adapted-physical-activity instructors.
Control groupProcedure or surgery
In the control group, patients will receive usual care from day-0 to day-180.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation group | Experimental | Individualized rehabilitation program Receives: Procedure: Rehabilitation group |
| Control group | Active comparator | Usual care Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute-walk distance
The primary endpoint is the 6-minute-walk distance (6MWD), in meters, assessed by blinded physicians and research nurses during a hospital visit 6 months after randomization.
Measured: 6 months
Secondary outcomes (32)
Handgrip strength
Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization
Measured: 6 months after randomization
Medical Research Council (MRC) score
MRC score at 6 months after randomization
Measured: 6 months after randomization
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
MAMC at 6 months after randomization
Measured: 6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 3 months after randomization
Measured: 3 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 4 months after randomization
Measured: 4 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 5 months after randomization
Measured: 5 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 6 months after randomization
Measured: 6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF score at 12 months after randomization
Measured: 12 months after randomization
Calorie intakes
Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
Measured: From day 0 to 12 months
Protein intakes
Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
Measured: From day 0 to 12 months
Body weight
Mean changes in body weight measured at 6 months)
Measured: 6 months
Mortality rates
90-day mortality rates
Measured: Day 90
Mortality rates
6-month mortality rates
Measured: 6 months
Mortality rates
12-months mortality rates
Measured: 12 months
Hypoglycemia
Proportion of patients with at least one hypoglycemia from day 0 to day 7
Measured: From day 0 to day 7
Blood glucose
Mean blood glucose from day 0 to day 7
Measured: From day 0 to day 7
Quality of life assessed using the Short Form 36 Health Survey (SF-36)
SF-36 scores 6 and 12 months after randomization
Measured: 6 and 12 months
Handgrip strength
Handgrip strength (Kg and percent of predicted strength) at ICU discharge
Measured: ICU discharge, an average of 10 days
Handgrip strength
Handgrip strength (Kg and percent of predicted strength) at hospital discharge
Measured: Hospital discharge, an average of 20 days
Medical Research Council (MRC) score
MRC score at ICU discharge
Measured: ICU discharge, an average of 10 days
Medical Research Council (MRC) score
MRC score at hospital discharge
Measured: Hospital discharge, an average of 20 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
MAMC at ICU discharge
Measured: ICU discharge, an average of 10 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
MAMC at hospital discharge
Measured: Hospital discharge, an average of 20 days
Body weight
Mean changes in body weight measured at ICU discharge
Measured: ICU discharge, an average of 10 days
Mortality rates
ICU discharge mortality rates
Measured: ICU discharge, an average of 10 days
Mechanical Ventilation (MV) duration
Days of MV
Measured: From D0 until the date of cessation of mechanical ventilation, an average of 7 days
ICU-acquired infection
Proportion of patients with at least one ICU-acquired infection
Measured: From day 0 until the date of discharge from ICU, an average of 10 days
ICU and hospital stay lengths
ICU and hospital stay lengths (days)
Measured: From day 0 until the day of discharge from hospital, an average of 20 days
Mortality rates
Hospital discharge mortality rates
Measured: Hospital discharge, an average of 20 days
Insulin
Days on insulin in the ICU
Measured: From day 0 until the date of ICU discharge, an average of 10 days
Delay from randomization to first standing-up
Delay from randomization to first standing-up (days)
Measured: From date of randomization until the date of first standing-up, an average of 7 days
Delay from randomization to first walking
Delay from randomization to first walking (days)
Measured: From date of randomization until the date of first walking, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start14 Dec 2024
- Primary completion14 Dec 2027 (estimated)
- Study completion14 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean REIGNIER, MD, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581939
- Sponsor's protocol ID
- RC23_0585
- Acronym
- NUTRIREA-4
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the demographic characteristics and primary and secondary outcomes reported in the main publication, together with the data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU : A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06581939
- Acronym / sponsor ID
- NUTRIREA-4 / RC23_0585
- Conditions
- Mechanical Ventilation
- Keywords
- Critical care, Nutritional support, Mechanical ventilation, Shock, Macronutrients, Rehabilitation, Physiotherapy, Adapted physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2024 (actual)
- Primary completion
- 14 Dec 2027 (estimated)
- Study completion
- 14 Jun 2028 (estimated)
- First posted
- 3 Sep 2024 (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.
The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care.
From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation group | Experimental | Procedure: Rehabilitation groupIndividualized rehabilitation program |
| Control group | Active comparator | Procedure: Control groupUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, and expected to be required for at least 48 hours after randomization
- Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
- Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)
- Age 18 or older
- Patient and/or next-of-kin informed about the trial and having consented to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law.
Key exclusion criteria (17 listed)
- MV started more than 24 hours earlier
- Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease
- Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission
- Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence)
- Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name)
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 |
|---|---|---|
| Rehabilitation groupIn the rehabilitation group, patients will follow an individualized rehabilitation program started early in the ICU and continued in the post-ICU ward then at home for 12 weeks, combining goal-directed nutrition and physical activity, tailored to gains made over time by each patient, with the involvement of dieticians, physiotherapists, and adapted-physical-activity instructors. | Procedure or surgery | Rehabilitation group |
| Control groupIn the control group, patients will receive usual care from day-0 to day-180. | Procedure or surgery | Control group |
Primary outcome
6-minute-walk distance
Time frame: 6 months
The primary endpoint is the 6-minute-walk distance (6MWD), in meters, assessed by blinded physicians and research nurses during a hospital visit 6 months after randomization.
32 secondary outcomes
Handgrip strength
Time frame: 6 months after randomization
Medical Research Council (MRC) score
Time frame: 6 months after randomization
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Time frame: 6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 3 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 4 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 5 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 12 months after randomization
Calorie intakes
Time frame: From day 0 to 12 months
Protein intakes
Time frame: From day 0 to 12 months
Body weight
Time frame: 6 months
Mortality rates
Time frame: Day 90
Mortality rates
Time frame: 6 months
Mortality rates
Time frame: 12 months
Hypoglycemia
Time frame: From day 0 to day 7
Blood glucose
Time frame: From day 0 to day 7
Quality of life assessed using the Short Form 36 Health Survey (SF-36)
Time frame: 6 and 12 months
Handgrip strength
Time frame: ICU discharge, an average of 10 days
Handgrip strength
Time frame: Hospital discharge, an average of 20 days
Medical Research Council (MRC) score
Time frame: ICU discharge, an average of 10 days
Medical Research Council (MRC) score
Time frame: Hospital discharge, an average of 20 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Time frame: ICU discharge, an average of 10 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
Time frame: Hospital discharge, an average of 20 days
Body weight
Time frame: ICU discharge, an average of 10 days
Mortality rates
Time frame: ICU discharge, an average of 10 days
Mechanical Ventilation (MV) duration
Time frame: From D0 until the date of cessation of mechanical ventilation, an average of 7 days
ICU-acquired infection
Time frame: From day 0 until the date of discharge from ICU, an average of 10 days
ICU and hospital stay lengths
Time frame: From day 0 until the day of discharge from hospital, an average of 20 days
Mortality rates
Time frame: Hospital discharge, an average of 20 days
Insulin
Time frame: From day 0 until the date of ICU discharge, an average of 10 days
Delay from randomization to first standing-up
Time frame: From date of randomization until the date of first standing-up, an average of 7 days
Delay from randomization to first walking
Time frame: From date of randomization until the date of first walking, an average of 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the demographic characteristics and primary and secondary outcomes reported in the main publication, together with the data dictionary.
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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.
Jean REIGNIER, MD, PhD principal investigator
Nantes University Hospital
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation group in people with Mechanical Ventilation, run by Nantes University Hospital at 52 sites in France.
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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane MAUGARS (+33(0)253482473, diane.maugars@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute-walk distance (time frame: 6 months). 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 2 Oct 2026.