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Can tailored nutrition and exercise after ICU boost recovery?

NCT ID NCT06581939

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a personalized program of nutrition and physical activity, started early in the ICU and continued at home, helps people recover better after being on a breathing machine and heart-support drugs. 830 adults will be randomly assigned to either this program or usual care. The main goal is to see how far they can walk in 6 minutes, 6 months later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
individualized rehabilitation program combining nutritional therapy, physiotherapy, and physical activity
What this could lead to
If it works, this could point toward a standard rehab program to help ICU survivors recover faster and better after a serious illness.
What could go wrong
This is a large trial, but the intervention is complex and depends on patient adherence. Results may not apply to all ICU patients, and the program requires significant resources.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 830 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

Shock

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mechanical ventilation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    52 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH d'Albi

    RECRUITING

    Albi, 81013, France

  • CH d'Angoulème

    RECRUITING

    Angoulême, 16959, France

  • CH d'Annecy Genevois

    RECRUITING

    Épagny, 74370, France

  • CH d'Argenteuil

    RECRUITING

    Argenteuil, 95100, France

  • CH d'Haguenau

    RECRUITING

    Haguenau, 67504, France

  • CH d'Orléans

    RECRUITING

    Orléans, 45100, France

  • CH de Belfort

    RECRUITING

    Belfort, 90015, France

  • CH de Béthune

    RECRUITING

    Béthune, 62408, France

  • CH de Cholet

    RECRUITING

    Cholet, 49325, France

  • CH de Dieppe

    RECRUITING

    Dieppe, 76202, France

  • CH de Lens

    RECRUITING

    Lens, 62300, France

  • CH de Lomme

    RECRUITING

    Lomme, 59462, France

  • CH de Lorient

    RECRUITING

    Lorient, 56100, France

  • CH de Saint-Brieuc

    RECRUITING

    Saint-Brieuc, 22027, France

  • CH de Saint-Malo

    RECRUITING

    St-Malo, 35403, France

  • CH de Valenciennes

    RECRUITING

    Valenciennes, 59322, France

  • CH de Vannes

    RECRUITING

    Vannes, 56017, France

  • CH de Vendée

    RECRUITING

    La Roche-sur-Yon, 85925, France

  • CH de Verdun

    RECRUITING

    Verdun, 55100, France

  • CH du Mans

    RECRUITING

    Le Mans, 72037, France

  • CHRU de Lille

    RECRUITING

    Lille, 59037, France

  • CHU d'Amiens

    RECRUITING

    Amiens, 80054, France

  • CHU d'Amiens - Site Sud

    RECRUITING

    Amiens, 80054, France

  • CHU d'Angers

    RECRUITING

    Angers, 49933, France

  • CHU de Besançon

    RECRUITING

    Besançon, 25030, France

  • CHU de Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33000, France

  • CHU de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU de Dijon

    RECRUITING

    Dijon, 21079, France

  • CHU de Grenoble

    RECRUITING

    Grenoble, 38043, France

  • CHU de Lyon

    RECRUITING

    Lyon, 69437, France

  • CHU de Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU de Nantes

    RECRUITING

    Nantes, 44000, France

  • CHU de Nice

    RECRUITING

    Nice, 06200, France

  • CHU de Nice - Hôpital Pasteur

    RECRUITING

    Nice, 06100, France

  • CHU de Reims

    RECRUITING

    Reims, 51092, France

  • CHU de Rennes

    RECRUITING

    Rennes, 35033, France

  • CHU de Rouen

    RECRUITING

    Rouen, 76000, France

  • CHU de Saint-Etienne

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • CHU de Strasbourg - Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67200, France

  • CHU de Strasbourg - Nouvel Hôpital Civil

    RECRUITING

    Strasbourg, 67091, France

  • CHU de Tours

    RECRUITING

    Tours, 37044, France

  • Centre Hospitalier Sud Essonne

    RECRUITING

    Étampes, 91150, France

  • Centre Hospitalier William Morey

    RECRUITING

    Chalon-sur-Saône, 71100, France

  • Centre Hospitalier de Saint-Nazaire

    RECRUITING

    Saint-Nazaire, 44600, France

  • Hôpital Cochin - AP-HP

    RECRUITING

    Paris, 75014, France

  • Hôpital Delafontaine

    RECRUITING

    Saint-Denis, 93200, France

  • Hôpital Foch

    RECRUITING

    Suresnes, 92150, France

  • Hôpital Raymond Poincaré - AP-HP

    RECRUITING

    Garches, 92380, France

  • Hôpital Saint-Louis - AP-HP

    RECRUITING

    Paris, 75010, France

  • Hôpital Tenon - AP-HP

    RECRUITING

    Paris, 75970, France

  • Hôpital de Bicêtre - AP-HP

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital la Pitié-Salpétrière - AP-HP

    RECRUITING

    Paris, 75651, France

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Other studies related to the condition(s) this trial covers.