Home › Trials › NCT06581939

Rehabilitation program for ICU patients on mechanical ventilation

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

NA · Nantes University Hospital · NCT06581939

This study is testing a special rehabilitation program that includes nutrition and exercise for ICU patients on ventilators to see if it helps them recover better after their hospital stay.

Quick facts

PhaseNA
Study typeInterventional
Enrollment830 (estimated)
Ages18 Years and up
SexAll
SponsorNantes University Hospital (other)
Locations52 sites (Albi and 51 other locations)
Trial IDNCT06581939 on ClinicalTrials.gov

What this trial studies

The NUTRIREA-4 trial aims to evaluate the effectiveness of a tailored rehabilitation program that combines nutritional therapy, physiotherapy, and physical activity for patients who have undergone invasive mechanical ventilation and vasopressor therapy in the ICU. Participants will be randomly assigned to receive either the early extended rehabilitation program or usual care, with the goal of improving long-term outcomes for critically ill survivors. The program will begin in the ICU and continue through the post-ICU recovery phase and at home after discharge. This approach seeks to enhance both general and muscle health in patients recovering from critical illness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have recently started invasive mechanical ventilation and are receiving vasopressor therapy for shock.

Not a fit: Patients who have been on mechanical ventilation for more than 24 hours prior to enrollment or have specific nutritional needs may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve recovery outcomes and quality of life for patients after critical illness.

How similar studies have performed: Other studies have shown promising results with similar rehabilitation approaches in critical care settings, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Albi and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Mechanical Ventilation, Critical care, Nutritional support, Mechanical ventilation, Shock, Macronutrients, Rehabilitation, Physiotherapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.