Brief 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.

Conditions

• Mechanical Ventilation

Intervention / Treatment

• Procedure: Rehabilitation group
• Procedure: Control group

Primary Outcome Measures

• 6-minute-walk distance (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.

Countries

France

Locations and Investigators

• CH d'Albi, Albi, France (Recruiting)
  • Christophe HENRY
• CHU d'Amiens - Site Sud, Amiens, France (Recruiting)
  • Julien MAIZEL
• CHU d'Amiens, Amiens, France (Recruiting)
  • Stéphanie MALAQUIN
• CHU d'Angers, Angers, France (Recruiting)
  • Marc PIERROT
• CH d'Angoulème, Angoulême, France (Recruiting)
  • Laurent LAINE
• CH d'Argenteuil, Argenteuil, France (Recruiting)
  • Gaëtan PLANTEFEVE
• CH de Belfort, Belfort, France (Recruiting)
  • Julio BADIE
• CHU de Besançon, Besançon, France (Recruiting)
  • Gaël PITON
• CH de Béthune, Béthune, France (Recruiting)
  • Ghada SBOUI
• CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, France (Recruiting)
  • Vivien GUILLOTIN
• Centre Hospitalier William Morey, Chalon-sur-Saône, France (Recruiting)
  • Thomas MALDINEY
• CH de Cholet, Cholet, France (Recruiting)
  • Anne-Astrid BOURION
• CHU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
  • Claire DUPUIS
• CH de Dieppe, Dieppe, France (Recruiting)
  • Jean-Philippe RIGAUD
• CHU de Dijon, Dijon, France (Recruiting)
  • Jean-Pierre QUENOT
• CH d'Annecy Genevois, Épagny, France (Recruiting)
  • Marie ROUGON
• Centre Hospitalier Sud Essonne, Étampes, France (Recruiting)
  • Akli CHERMAK
• Hôpital Raymond Poincaré - AP-HP, Garches, France (Recruiting)
  • Virginie MAXIME
• CHU de Grenoble, Grenoble, France (Recruiting)
  • Louis-Marie GALERNEAU
• CH d'Haguenau, Haguenau, France (Recruiting)
  • Quentin GEORGES
• CH de Vendée, La Roche-sur-Yon, France (Recruiting)
  • Isabelle VINATIER
• Hôpital de Bicêtre - AP-HP, Le Kremlin-Bicêtre, France (Recruiting)
  • Laurent GUERIN
• CH du Mans, Le Mans, France (Recruiting)
  • Mickaël LANDAIS
• CH de Lens, Lens, France (Recruiting)
  • Olivier NIGEON
• CHRU de Lille, Lille, France (Recruiting)
  • Claire BOUREL
• CH de Lomme, Lomme, France (Recruiting)
  • Thierry VAN DER LINDEN
• CH de Lorient, Lorient, France (Recruiting)
  • Béatrice LACOMBE
• CHU de Lyon, Lyon, France (Recruiting)
  • Laurent ARGAUD
• CHU de Montpellier, Montpellier, France (Recruiting)
  • Samir JABER
• CHU de Nantes, Nantes, France (Recruiting)
  • Jean REIGNIER, MD
• CHU de Nice - Hôpital Pasteur, Nice, France (Recruiting)
  • Matthieu BOIFFIER
• CHU de Nice, Nice, France (Recruiting)
  • Clément SACCHERI
• CH d'Orléans, Orléans, France (Recruiting)
  • Maxime DESGROUAS
• Hôpital Saint-Louis - AP-HP, Paris, France (Recruiting)
  • Michael DARMON
• Hôpital Cochin - AP-HP, Paris, France (Recruiting)
  • Jean-Paul MIRA
• Hôpital la Pitié-Salpétrière - AP-HP, Paris, France (Recruiting)
  • Elise MORAWIEC
• Hôpital Tenon - AP-HP, Paris, France (Recruiting)
  • BEURTON Alexandra
• CHU de Reims, Reims, France (Recruiting)
  • Maxime BERTRAND
• CHU de Rennes, Rennes, France (Recruiting)
  • Jean-Marc TADIE
• CHU de Rouen, Rouen, France (Recruiting)
  • Fabienne TAMION
• CH de Saint-Brieuc, Saint-Brieuc, France (Recruiting)
  • Mattieu DEBARRE
• Hôpital Delafontaine, Saint-Denis, France (Recruiting)
  • Daniel SILVA
• Centre Hospitalier de Saint-Nazaire, Saint-Nazaire, France (Recruiting)
  • Damien MULLER
• CHU de Saint-Etienne, Saint-Priest-en-Jarez, France (Recruiting)
  • Guillaume THIERY
• CH de Saint-Malo, St-Malo, France (Recruiting)
  • Nicolae-Vlad BOTOC
• CHU de Strasbourg - Nouvel Hôpital Civil, Strasbourg, France (Recruiting)
  • Hamid MERDJI
• CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg, France (Recruiting)
  • Jean-Etienne HERBRECHT
• Hôpital Foch, Suresnes, France (Recruiting)
  • Jérôme DEVAQUET
• CHU de Tours, Tours, France (Recruiting)
  • Emmanuelle MERCIER
• CH de Valenciennes, Valenciennes, France (Recruiting)
  • Fabien LAMBIOTTE

And 2 other sites.

Study Officials

• Jean REIGNIER, MD, PhD (Principal Investigator) — Nantes University Hospital