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RECRUITING
NCT06581939
NA

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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