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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
Sponsor: Nantes University Hospital
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 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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
830
Start Date
2024-12-14
Completion Date
2027-12-14
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Rehabilitation group
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 group
In the control group, patients will receive usual care from day-0 to day-180.
Locations (52)
CH d'Albi
Albi, France
CHU d'Amiens - Site Sud
Amiens, France
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CH d'Angoulème
Angoulême, France
CH d'Argenteuil
Argenteuil, France
CH de Belfort
Belfort, France
CHU de Besançon
Besançon, France
CH de Béthune
Béthune, France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
CH de Cholet
Cholet, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CH de Dieppe
Dieppe, France
CHU de Dijon
Dijon, France
CH d'Annecy Genevois
Épagny, France
Centre Hospitalier Sud Essonne
Étampes, France
Hôpital Raymond Poincaré - AP-HP
Garches, France
CHU de Grenoble
Grenoble, France
CH d'Haguenau
Haguenau, France
CH de Vendée
La Roche-sur-Yon, France
Hôpital de Bicêtre - AP-HP
Le Kremlin-Bicêtre, France
CH du Mans
Le Mans, France
CH de Lens
Lens, France
CHRU de Lille
Lille, France
CH de Lomme
Lomme, France
CH de Lorient
Lorient, France
CHU de Lyon
Lyon, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
CHU de Nice - Hôpital Pasteur
Nice, France
CHU de Nice
Nice, France
CH d'Orléans
Orléans, France
Hôpital Saint-Louis - AP-HP
Paris, France
Hôpital Cochin - AP-HP
Paris, France
Hôpital la Pitié-Salpétrière - AP-HP
Paris, France
Hôpital Tenon - AP-HP
Paris, France
CHU de Reims
Reims, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
CH de Saint-Brieuc
Saint-Brieuc, France
Hôpital Delafontaine
Saint-Denis, France
Centre Hospitalier de Saint-Nazaire
Saint-Nazaire, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
CH de Saint-Malo
St-Malo, France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Hôpital Foch
Suresnes, France
CHU de Tours
Tours, France
CH de Valenciennes
Valenciennes, France
CH de Vannes
Vannes, France
CH de Verdun
Verdun, France